Structure LinkId Text Cardinality Type Flags Description & Constraints Protocol_questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate#1.0.0 p1 Research Study 0..1 group p1.1 Study Type 1..1 choice Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding p1.1_help Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) 0..1 display p1.2 Intervention 1..1 choice Enable When: p1.1 = Interventional (Temporary Codes#INT) Options: 4 options p1.2_help A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise. 0..1 display p1.3 Does this protocol require a FDA exemption? 0..1 choice Enable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV) p1.2 = Device (Temporary Codes#DEV) Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding p1.30 Is an IND or IDE being used in this study? 0..1 choice Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding p1.30_help Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? 0..1 display p1.4 Type of exemption 0..1 choice Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding p1.4_help Select Investigational New Drug (IND) or Investigational Device Exemption (IDE) 0..1 display p1.5 Study Title 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.1').answer.value p1.5_help The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s) 0..1 display p1.6 Study Title (Short) 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value p1.6_help A short study title written in language intended for the lay public. 0..1 display p1.61 Lead Principal Investigator 0..1 group p1.61.1 First Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value p1.61.1_help First or given name of the lead principal investigator 0..1 display p1.61.2 Last Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value p1.61.2_help Surname or family name 0..1 display p1.61.7 Suffix 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value p1.61.7_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display p1.61.8 Degree(s) 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value p1.61.8_help Professional and Academic degrees of the lead principal investigator 0..1 display p1.61.3 Department Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value p1.61.4 Address 0..1 group p1.61.4.1 Street Address 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value p1.61.4.2 City 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value p1.61.4.3 State 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value p1.61.4.4 Zip Code 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value p1.61.4.5 Country 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value p1.61.5 Phone 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value p1.61.5_help 10-digit phone number, including area code 0..1 display p1.61.6 Email 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value p1.61_help The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm 0..1 display p1.7 Additional Investigator 0..1 choice Options: 2 options p1.7_help Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial. 0..1 display p1.8 Additional Investigator 0..* group Enable When: p1.7 = Yes (expandedYes-NoIndicator#Y) p1.8.1 Additional Investigator Role 0..1 open-choice Options: 3 options p1.8.2 First Name 0..1 string p1.8.2_help First or given name of the additional investigator 0..1 display p1.8.3 Last Name 0..1 string p1.8.3_help Surname or family name 0..1 display p1.8.8 Suffix 0..1 string p1.8.8_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display p1.8.9 Degree(s) 0..1 string p1.8.9_help Professional and Academic degrees of the additional investigator 0..1 display p1.8.4 Department Name 0..1 string p1.8.5 Address 0..1 group p1.8.5.1 Street Address 0..1 string p1.8.5.2 City 0..1 string p1.8.5.3 State 0..1 string p1.8.5.4 Zip Code 0..1 string p1.8.5.5 Country 0..1 string p1.8.6 Phone 0..1 string p1.8.6_help 10-digit phone number, including area code 0..1 display p1.8.7 Email 0..1 string p1.9 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value p1.9_help Provided by the sIRB. Will not be available at the time of initial submission. 0..1 display p1.10 Sponsor Name(s) and Protocol Number 0..1 group ExternalDataFor_p1.10.1.1 External Data For linkId p1.10.1.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value p1.10.1 Sponsor 0..* group p1.10.1.1 Sponsor Name 0..1 open-choice p1.10.1.2 Sponsor Protocol Number 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.where(answer.valueString = %sponsorSelectedThisRepetition)).item.where(linkId = 'in5.4').answer.valueString p1.10.1.2_help Unique Protocol Identification Number used by the sponsor. 0..1 display p1.11 ClinicalTrials.Gov Identifier 0..1 string p1.11_help The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). 0..1 display p1.12 Grant Title 0..1 text p1.12_help Funding Opportunity Title 0..1 display p1.13 NIH Grant Number 0..1 text p1.14 IND Number 0..1 string Enable When: p1.4 = IND (Temporary Codes#IND) Expressions: Calculated Value: iif(%typeExemptionIDEIDN = 'IND', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value) p1.15 IDE Number 0..1 string Enable When: p1.4 = IDE (Temporary Codes#IDE) Expressions: Calculated Value: iif(%typeExemptionIDEIDN = 'IDE', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value) p1.16 Study Product Name 0..1 text p1.16_help Generic, followed by marketed name if applicable 0..1 display p1.17 Study Product Provider 0..1 text p1.17_help e.g. NIH, or company 0..1 display p1.18 Funding Organization(s), Address and Contact Information 0..1 group ExternalDataFor_p1.18.1.1 External Data For linkId p1.18.1.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value p1.18.1 Funding Organization 0..* group p1.18.1.1 Name 0..1 open-choice p1.18.1.2 Address 0..1 group p1.18.1.2.1 Street Address 0..1 string p1.18.1.2.2 City 0..1 string p1.18.1.2.3 State 0..1 string p1.18.1.2.4 Zip Code 0..1 string p1.18.1.2.5 Country 0..1 string p1.18.1.5 Phone 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %fundingOrgName)).item.where(linkId = 'in5.3').answer.value p1.18.1.5_help 10-digit phone number, including area code 0..1 display p1.18.1.4 Email 0..1 string p1.18_help e.g. NIH, or company 0..1 display p1.19 Sponsor(s), Address and Contact Information 0..1 group ExternalDataFor_p1.19.1.1 External Data For linkId p1.19.1.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value p1.19.1 Sponsor 0..* group p1.19.1.1 Name 0..1 open-choice p1.19.1.2 Department Name 0..1 string p1.19.1.3 Address 0..1 group p1.19.1.3.1 Street Address 0..1 string p1.19.1.3.2 City 0..1 string p1.19.1.3.3 State 0..1 string p1.19.1.3.4 Zip Code 0..1 string p1.19.1.3.5 Country 0..1 string p1.19.1.4 Email 0..1 string p1.19.1.5 Phone 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %sponsorOrgNameSelectedThisRepetition)).item.where(linkId = 'in5.3').answer.value p1.19.1.5_help 10-digit phone number, including area code 0..1 display p1.19_help Individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation. 0..1 display p1.20 Medical Monitor 0..1 group p1.20_help Medical expert for the clinical trial 0..1 display p1.20.1 First Name 0..1 string p1.20.1_help First or given name of the medical monitor 0..1 display p1.20.2 Last Name 0..1 string p1.20.2_help Surname or family name 0..1 display p1.20.6 Suffix 0..1 string p1.20.6_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display p1.20.7 Degree(s) 0..1 string p1.20.7_help Professional and Academic degrees of the medical monitor 0..1 display p1.20.3 Phone 0..1 string p1.20.3_help 10-digit phone number, including area code 0..1 display p1.20.4 Email 0..1 string p1.20.5 Address 0..1 group p1.20.5.1 Street Address 0..1 string p1.20.5.2 City 0..1 string p1.20.5.3 State 0..1 text p1.20.5.4 Zip Code 0..1 string p1.20.5.5 Country 0..1 string p1.21 Confidentialty Statement 0..1 text p1.23 Protocol Version Number 0..1 string p1.24 Protocol Version Date 0..1 date p2 Protocol Amendment Summary of Changes Table 0..* group p2.1 Affected Section(s) 0..1 text p2.2 Summary of Revisions Made 0..1 text p2.3 Rationale 0..1 text p2.4 Statement of Compliance 1..1 text Initial Value: string = [Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be IRB-approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.] p2.4_help Select one of the two statements below. If the study is an intramural NIH study, use the second statement below 0..1 display p3 Protocol Summary 0..1 group p3.1 Synopsis 0..1 group p3.1.1 Title (Full) 0..1 string Expressions: Initial Value: %resource.item.item.where(linkId = 'p1.5').answer.value p3.1.2 Title (Short) 0..1 string Expressions: Initial Value: %resource.item.item.where(linkId = 'p1.6').answer.value p3.1.3 Study Description 0..1 text p3.1.3_help Short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length. A detailed schematic describing all visits and a schedule of assessments should be included in the Schema and Schedule of Activities 0..1 display p3.1.4 Objectives 0..1 text p3.1.4_help Include the primary and secondary objectives.Theseobjectives should be thesame as the objectives contained in the body of the protocol. These align with Primary Purpose in clinicaltrials.gov 0..1 display p3.1.5 End Points 0..1 text p3.1.5_help Primary endpoint and secondary endpoints.These endpoints should be the same as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov 0..1 display p3.1.6 Accrual Ceiling/Number of Participants (projected-for all sites) 0..1 integer p3.1.6_help The total number of subjects expected to complete the study. This includes expected sample size and estimated ineligible persons after signing a screening consent. 0..1 display p3.1.7 Study Population 0..1 text p3.1.7_help Specify sample size, gender, age, demographic group, general health status, and geographic location. 0..1 display p3.1.8 Phase 0..1 choice Options: 3 options p3.1.8_help Applies to drugs and biologics. 0..1 display p3.1.9 Description of Sites/Facilities Enrolling Participants 0..1 text p3.1.9_help Brief description of planned facilities/participating sites enrolling participants. Indicate number of sites and if the study is intended to include sites outside the United States. 0..1 display p3.1.10 Description of Study Intervention ( Agent/Procedure)/Investigational Product 0..1 text p3.1.10_help Describe the study intervention. If the study interventionis a drug or biologic, include dose and route of administration. For devices,provide a description ofeach important component, ingredient,property and the principle of operation of the device. 0..1 display p3.1.11 Study Duration 0..1 text p3.1.11_help Estimated time (in months) from when the study opens to enrollment until completion of data analyses 0..1 display p3.1.12 Participant Duration 0..1 text p3.1.12_help Time (e.g., in months) it will take for each individual participant to complete all participant visits. 0..1 display p3.1.13 Methodology 0..1 text p3.1.13_help Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc. 0..1 display p3.1.14 Duration of Investigational Product Administration 0..1 text Enable When: p1.1 = Interventional (Temporary Codes#INT) p3.1.14_help Total duration of investigational product administration (including any open-label lead-in, if applicable). 0..1 display p3.1.15 Key Procedures 0..1 text p3.1.15_help Procedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws) 0..1 display p3.1.16 Main Inclusion/Exclusion Criteria 0..1 text p3.1.16_help Entire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section. 0..1 display p3.1.17 Reference Therapy 0..1 text Enable When: p1.1 = Interventional (Temporary Codes#INT) p3.1.17_help Note if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo 0..1 display p3.1.18 Statistical Analysis 0..1 text p3.1.18_help A very brief description of the main elements of the statistical methodology to be used in the study. Limit this section to discussion of the analysis of the primary endpoint and perhaps the main secondary endpoint. 0..1 display p3.2 Schema 0..1 group p3.2.1 Attach schema here 0..1 attachment p3.2_help This section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.) The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 +/- 7; etc. 0..1 display p3.3 Schedule of Activities 0..1 group p3.3.1 Schedule of Activities 0..1 text p3.3.1_help Describe the schedule of activities in the text box here or attach a copy of the Schedule of Activities below. 0..1 display p3.3.3 Schedule of Activities Attachment 0..1 group p3.3.3.1 Describe the file that is being attached (optional) 0..1 string p3.3.3.2 Attachment 0..1 attachment p3.3_help The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment. Either describe in the text box here or attach a copy of the Schedule of Activities. 0..1 display p4 Introduction, Background Information and Scientific Rational 0..1 group p4.1 Background 0..1 group p4.1.1 Describe the relevant literature and the specific gaps in current knowledge that this study intends to address 0..1 text p4.1.1_help Gaps that this study intends to address based on literature 0..1 display p4.1.2 Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge 0..1 text p4.1.2_help Based on the existing literature and how it will add to existing knowledge 0..1 display p4.1.3 Describe the relevance and usefulness of the objectives 0..1 text p4.1.4 Is this the first time the study drug, device, or intervention/procedure will be used in humans. 0..1 choice Options: 2 options p4.1.5 If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date 0..1 text Enable When: p4.1.4 = No (expandedYes-NoIndicator#N) p4.1.5_help Details If the intervention/drug/device is not the first time used. 0..1 display p4.1.6 Investigational Product 0..1 group Enable When: p1.1 = Interventional (Temporary Codes#INT) p4.1.6_help In this section include the name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable. 0..1 display p4.1.6.1 Name and Description 0..1 text p4.1.6.2 Preclinical Data 0..1 text p4.1.6.3 Clinical Data to Date 0..1 group p4.1.6.3.1 Human Pharmacokinetics 0..1 text p4.1.6.3.2 Clinical Studies in adults 0..1 text p4.1.6.3.3 Clinical Studies in Children 0..1 text p4.1.7 Is there an active control group? 0..1 choice Options: 2 options p4.1.8 Active Control Group 0..1 group Enable When: p4.1.7 = Yes (expandedYes-NoIndicator#Y) p4.1.8.1 Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment 0..1 text p4.1.8.2 Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study. 0..1 choice Options: 2 options p4.1.8.3 Is the active control an established effective intervention? 0..1 choice Options: 2 options p4.1.8.4 If no, clarify how it is ethically justified to use this control in the study 0..1 text Enable When: p4.1.8.3 = No (expandedYes-NoIndicator#N) p4.2 Study Rationale 0..1 text p4.2_help The problems or question and reason for conducting the study. E.g. explain the population, disease, standard of care (if there is one), and limitations of knowledge or available therapy. 0..1 display p4.3 Risk/Benefit Assessment 0..1 group p4.3.1 Potential Risks 0..1 group p4.3.1.1 List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks 0..1 text p4.3.1.2 State which study interventions may have unknown risks 0..1 text p4.3.1.3 State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant 0..1 text p4.3.1.4 Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community 0..1 text p4.3.1.5 Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):? 0..1 choice Options: 2 options p4.3.1.6 Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.) 0..1 group Enable When: p4.3.1.5 = Yes (expandedYes-NoIndicator#Y) p4.3.1.6.1 Describe these risks 0..1 text p4.3.1.6.2 Describe the procedures that will be put in place to minimize these risks 0..1 text p4.3.1.6.3 Describe how these procedures are adequate for the location where study procedures will be performed 0..1 text p4.3.1.7 Other risks 0..1 text p4.3.2 Potential Benefits 0..1 group p4.3.2.1 Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits 0..1 text p4.3.2.1_help Note: Payments and incentives are not considered benbefits. 0..1 display p4.3.2.2 Describe any benefit to the population from which the participant is drawn 0..1 text p4.3.2.3 Describe any benefit to science, society, and humanity in general 0..1 text p4.3.2.4 Other benefits 0..1 text p4.3.3 Alternatives to Study Participation 0..1 group p4.3.3.1 Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.) 0..1 text p4.3.3.2 Describe the standard clinical care that may be an alternative 0..1 text p4.3.3.3 Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting 0..1 text p4.3.3.4 Other alternatives to study participation 0..1 text p5 Study Purpose, Objectives or Specific Aims 0..1 group p5_help Describe the purpose, specific aims, or objectives of the study 0..1 display p5.1 Hypothesis 0..1 text p5.2 Primary Objectives 0..1 text p5.2_help The main question the study seeks to answer. 0..1 display p5.3 Secondary Objectives 0..1 text p5.3_help The secondary objective(s) are goals that will provide further information on the use of the intervention. 0..1 display p5.4 Tertiary/Exploratory Objectives 0..1 text p5.4_help Tertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research. 0..1 display p6 Study Endpoints 0..1 group p6_help Precise definitions of the study endpoints and criteria for evaluation 0..1 display p6.1 Primary Endpoints 0..1 text p6.1_help Description of primary endpoints identified in the primary Study Protocol. 0..1 display p6.1.1 Justification for Endpoints 0..1 text p6.1.1_help Briefly explain why the endpoint(s) were chosen. 0..1 display p6.2 Secondary Endpoints 0..1 text p6.2.1 Justification for Secondary Endpoints 0..1 text p6.2.1_help Briefly explain why the endpoint(s) were chosen. 0..1 display p6.3 Tertiary Endpoints 0..1 text p6.3_help Exploratory endpoints should be specified. Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. 0..1 display p6.3.1 Justification for Tertiary Endpoints 0..1 text p6.3.1_help Briefly explain why the endpoint(s) were chosen. 0..1 display p6.4 Primary Safety endpoints 0..1 text p6.5 Secondary Safety endpoints 0..1 text p6.6 Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims. 0..1 text p7 Study Design 0..1 group p7.1 Overall Design 0..1 text p7.1_help The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design should be consistent with the Protocol Synopsis and Protocol Schema. 0..1 display p7.2 Scientific Rationale for Study Design 0..1 text p7.2_help Describe the rationale for the type and selection of control (e.g. placebo, active drug, dose-response, historical) and study design (e.g., non-inferiority as opposed to superiority). Discuss known or potential problems associated with the control chosen in light of the specific disease and intervention(s) being studied. 0..1 display p7.3 Justification for Dose 0..1 text Enable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV) p7.4 Justification for Intervention 0..1 text Enable When: p1.1 = Interventional (Temporary Codes#INT) p7.4_help Provide a justification for the route of administration, planned maximum dosage, and dosing regimen, including starting dose, of the study intervention(s) and control product(s). 0..1 display p7.5 End of Study Definition 0..1 text p7.5_help A clinical trial is considered completed when participants are no longer being examined or the last participant's last study visit has occurred. 0..1 display p7.6 Screening Activities 0..1 text p7.7 Study Intervention Activities 0..1 text p7.8 Follow Up Activities 0..1 text p7.9 Allocation to Interventional Group 0..1 text p7.10 Study/Data Collection Instruments 0..1 text p7.11 Research Setting 0..1 text p7.15 Study Design Attachments 0..* group p7.15_help Attach documents related to the Study Design here such as Study Intervention Activities descriptions, Follow Up plans and Study/Data Collection Instruments 0..1 display p7.15.1 Describe the file that is being attached 0..1 string p7.15.2 Attachment 0..1 attachment p8 Study Population 0..1 group p8.1 Participant Selection 0..1 group p8.1.1 Category/Group (eg. Adults, controls, parents, children) 0..1 text p8.1.2 Age Range 0..1 text p8.1.3 Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures) 0..1 integer p8.1.4 Number Expected to Complete the Study or Needed to Address the Research Question 0..1 integer p8.1.5 Total Number of participants 0..1 integer p8.1.6 Overall study sample size (if multisite) 0..1 integer p9 Study Enrollment and Withdrawal 0..1 group p9.1 Eligibility Criteria 0..1 group p9.1.1 Inclusion and Exclusion Criteria 0..1 group p9.1.1.1 Inclusion Criteria 0..* text p9.1.1.1_help Description of criteria that define participants to include in study 0..1 display p9.1.1.2 Exclusion Criteria 0..* text p9.1.1.2_help Description of criteria that define participants to exclude in study 0..1 display p9.1.2 Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination) 0..1 text p9.1.3 State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study 0..1 text p9.1.4 Can study participants participate in another research study while participating in this research study 0..1 choice Options: 2 options p9.1.5 Screen Failures 0..1 text p9.1.5_help Participants who are consented to participate in the clinical trial, who do not meet one or more criteria required for participation in the trial during the screening procedures, are considered screen failures. Indicate how screen failures will be handled in the trial, including conditions and criteria upon which re-screening is acceptable, when applicable. 0..1 display p9.1.6 Lifestyle Considerations 0..1 text p9.1.6_help Describe any restrictions during any parts of the study pertaining to lifestyle and/or diet (e.g., food and drink restrictions, timing of meals relative to dosing, intake of caffeine, alcohol, or tobacco, or limits on activity), and considerations for household contacts. Describe what action will be taken if prohibited medications, treatments or procedures are indicated for care (e.g., early withdrawal). 0..1 display p9.1.7 Vulnerable Populations 0..1 group p9.1.7.1 Can or will pregnant women be enrolled 0..1 choice Options: 2 options p9.1.7.2 Enrollment of Pregnant Women 0..1 group Enable When: p9.1.7.1 = Yes (expandedYes-NoIndicator#Y) p9.1.7.2.1 Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses 0..1 text p9.1.7.2.2 Are there any risk to the fetus from the study interventions or procedures. 0..1 choice Options: 2 options p9.1.7.2.3 Risks to Fetus 0..1 text Enable When: p9.1.7.2.2 = Yes (expandedYes-NoIndicator#Y) p9.1.7.2.4 Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus 0..1 choice Options: 2 options p9.1.7.2.5 Describe benefit for the women or fetus 0..1 text Enable When: p9.1.7.2.4 = Yes (expandedYes-NoIndicator#Y) p9.1.7.2.6 If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means 0..1 text Enable When: p9.1.7.2.4 = No (expandedYes-NoIndicator#N) p9.1.7.2.7 Describe the biomedical knowledge that is expected to result from this research for this population 0..1 text p9.1.7.2.8 Describe how any risk of this research is the least possible for achieving the objectives of the research 0..1 text p9.1.7.2.9 Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate 0..1 text p9.1.7.3 Can or will the research involve neonates of uncertain viability or non-viable neonates? 0..1 choice Options: 2 options p9.1.7.31 Research involving neonates of uncertain viability or non-viable neonates 0..1 group Enable When: p9.1.7.3 = Yes (expandedYes-NoIndicator#Y) p9.1.7.31.1 Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates 0..1 text p9.1.7.31.2 Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means 0..1 text p9.1.7.31.3 Describe whether there will be added risk to the neonate resulting from the research 0..1 text p9.1.7.31.4 Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate 0..1 text p9.1.7.31.5 No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study 0..1 choice Options: 2 options p9.1.7.31.6 Individuals engaged in the research will have no part in determining the viability of a neonate 0..1 choice Options: 2 options p9.1.7.31.7 For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate 0..1 choice Options: 2 options p9.1.7.31.8 For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective 0..1 choice Options: 2 options p9.1.7.4 Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled? 0..1 choice Options: 2 options p9.1.7.5 Enrollment of participants who are not yet adults (neonates, children, teenagers) 0..1 group Enable When: p9.1.7.4 = Yes (expandedYes-NoIndicator#Y) p9.1.7.5.1 I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years). 0..1 choice Options: 2 options p9.1.7.5.1.1 If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined 0..1 text p9.1.7.5.2 Describe how permission to participate in the study will be obtained from the parents or legal guardians 0..1 text p9.1.7.5.3 Assent process of children 0..1 group p9.1.7.5.3.1 Describe waiting period between informing the prospective participant and obtaining the assent 0..1 text p9.1.7.5.3.2 Describe any process to ensure ongoing assent 0..1 text p9.1.7.5.3.3 Describe Research team members involved in the assent process 0..1 text p9.1.7.5.3.4 Describe how long children will have to consider study participation 0..1 text p9.1.7.5.3.5 Describe steps that will be taken to minimize the possibility of coercion or undue influence 0..1 text p9.1.7.5.3.6 Describe steps that will be taken to ensure the participants's understanding 0..1 text p9.1.7.5.3.7 If assent will not be obtained from children, specify why 0..1 text p9.1.7.5.3.8 Will children reach 18 years of age while in the study? 0..1 choice Options: 2 options p9.1.7.5.3.9 Children reaching 18 years of age while in the study 0..1 group Enable When: p9.1.7.5.3.8 = Yes (expandedYes-NoIndicator#Y) p9.1.7.5.3.9.1 Describe the plan to obtain written informed consent from the participant at age 18 years 0..1 text p9.1.7.5.3.9.2 Describe who will be responsible for managing the plan 0..1 text p9.1.7.5.3.9.3 Describe where the consent discussion will take place 0..1 text p9.1.7.5.3.9.4 Describe what will happen if the participant cannot be located to provide consent at age 18 years 0..1 text p9.1.7.6 Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child? 0..1 choice Options: 2 options p9.1.7.7 Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child. 0..1 group Enable When: p9.1.7.6 = Yes (expandedYes-NoIndicator#Y) p9.1.7.7.1 Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate 0..1 text p9.1.7.7.2 Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making 0..1 text p9.1.7.7.3 Describe any additional steps or procedures that will be used when performing informed consent with this population 0..1 text p9.1.7.8 Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled? 0..1 choice Options: 2 options p9.1.7.9 Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent 0..1 group Enable When: p9.1.7.8 = Yes (expandedYes-NoIndicator#Y) p9.1.7.9.1 Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context 0..1 text p9.1.7.9.2 Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent 0..1 text p9.1.7.9.4 Describe the process to determine whether or not the individual is capable of consent 0..1 text p9.1.7.9.5 Describe who will determine if the participant is able to provide informed consent 0..1 text p9.1.7.9.6 Describe how it will be determined whether the participant is able to provide informed consent 0..1 text p9.1.7.9.7 Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent 0..1 text p9.1.7.9.8 List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.) 0..1 text p9.1.7.9.9 If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent 0..1 text p9.1.7.9.10 Process for assent of participants 0..1 group p9.1.7.9.10.1 Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not 0..1 text p9.1.7.9.10.2 If assent will not be obtained from some or all participants, an explanation of why not 0..1 text p9.1.7.9.10.3 Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents 0..1 text p9.1.7.9.11 Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use 0..1 text p9.1.7.9.12 Participants will be withdrawn if they appear to be unduly distressed at any time during the study. 0..1 choice Options: 2 options p9.1.7.10 Can or will prisoners be enrolled? 0..1 choice Options: 2 options p9.1.7.11 Enrollment of prisoners 0..1 group Enable When: p9.1.7.10 = Yes (expandedYes-NoIndicator#Y) p9.1.7.11.1 Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired 0..1 text p9.1.7.11.2 Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers 0..1 text p9.1.7.11.3 Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project 0..1 text p9.1.7.11.4 Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole. 0..1 choice Options: 2 options p9.1.7.11.6 If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact 0..1 text p9.1.7.12 Can or will students and/or employees be enrolled in this research? 0..1 choice Options: 2 options p9.1.7.13 Enrollment of students and/or employees 0..1 group Enable When: p9.1.7.12 = Yes (expandedYes-NoIndicator#Y) p9.1.7.13.1 Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees 0..1 text p9.1.7.13.2 Describe how potential coercion will be eliminated 0..1 text p9.1.7.13.3 Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that 0..1 text p9.1.7.13.4 Describe additional safeguards included to protect the rights and welfare of students and employees 0..1 text p9.1.7.13.5 Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee 0..1 text p9.1.7.13.6 Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized. 0..1 choice Options: 2 options p9.1.7.14 Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)? 0..1 choice Options: 2 options p9.1.7.15 Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody). 0..1 group Enable When: p9.1.7.14 = Yes (expandedYes-NoIndicator#Y) p9.1.7.15.1 Describe the justification for recruiting and enrolling this population 0..1 text p9.1.7.15.2 Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that 0..1 text p9.1.7.15.3 Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that 0..1 text p9.1.7.15.4 Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research 0..1 text p9.1.7.15.5 Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian 0..1 text p9.1.7.15.6 Is the study is greater than minimal risk? 0..1 choice Options: 2 options p9.1.7.15.7 Greater than minimal risk study 0..1 group Enable When: p9.1.7.15.6 = Yes (expandedYes-NoIndicator#Y) p9.1.7.15.7.1 Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards 0..1 text p9.1.7.15.7.2 Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis 0..1 text p9.1.7.15.7.3 Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research 0..1 text p9.1.7.15.7.4 The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. 0..1 choice Options: 2 options p9.2 Strategies for Recruitment and Retention 0..1 group p9.2.1 Recruitment Methods 0..1 group p9.2.1.1 Describe when, where, and how potential participants will be recruited 0..1 text p9.2.1.1_help Provide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire. 0..1 display p9.2.1.2 When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.). 0..1 text p9.2.1.3 Describe source of participants (for example, patient population, local community, etc.) 0..1 text p9.2.1.4 Describe methods that will be used to identify potential participants 0..1 text p9.2.1.5 Describe how the recruitment methods described will be effective in attracting the targeted participant population 0..1 text p9.3 Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.) 0..1 text p10 Study Intervention 0..1 group Enable When: p1.1 = Interventional (Temporary Codes#INT) p10.1 Study Agent 0..1 group p10.1.1 Study Agent and Control Description 0..1 text p10.1.2 Receipts/Acquisition 0..1 text p10.1.2_help State how the study intervention and control product will be provided to the investigator, including who will be supplying the investigational product and any other protocol dictated medications/devices. If investigational product(s) will be purchased through commercial sources, state this. 0..1 display p10.1.3 Study Agent Accountability/ Return or Destruction of Investigational Product 0..1 text p10.1.3_help Describe plans about how and by whom the study intervention will be distributed, including participation of a drug repository or pharmacy, and plans for disposal of expired or return of unused product. 0..1 display p10.1.4 Formulation and appearance of Control Product 0..1 text p10.1.4_help Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product. 0..1 display p10.1.5 Formulation and appearance of Test Product 0..1 text p10.1.5_help Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product. 0..1 display p10.1.6 Packaging and Labeling 0..1 text p10.1.6_help Describe the packaging and labeling of the study intervention and control product, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling. 0..1 display p10.1.7 Product Storage and Stability 0..1 text p10.1.7_help Describe storage and stability requirements (e.g., protection from light, temperature, humidity) for the study intervention and control product. For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken). 0..1 display p10.1.8 Preparation 0..1 text p10.1.8_help Description of the preparation of the study intervention and control product, including any preparation required by study staff and/or study participants. Include thawing, diluting, mixing, and reconstitution/preparation instructions, as appropriate. For devices, include any relevant assembly or use instructions. 0..1 display p10.1.9 Administration and/or Dosing 0..1 text p10.1.9_help Describe the procedures for selecting each participant's dose of study intervention and control product. For drugs, that includes the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time study participants will be administered the study intervention), the planned route of administration (e.g., oral, nasal, intramuscular), and the relation of dosing to meals. 0..1 display p10.1.10 Route of Administration 0..1 text p10.1.11 Starting Dose and Dose Escalation Schedule 0..1 text p10.1.11_help State the starting dose and schedule of the study intervention and control product, including the maximum and minimum duration for those participants who continue in the study. For example, in some oncology trials for participants with no available therapeutic alternatives, intervention continues even after disease progression. In this instance, consider alternative designs that enable participants to rollover to a continued treatment arm and include appropriate instructions to guide this implementation. 0..1 display p10.1.12 Dose Adjustments/Modifications/Delays 0..1 text p10.1.13 Duration of Therapy 0..1 text p10.1.14 Tracking Dose 0..1 text p10.1.15 Device Specific Considerations 0..1 text p10.1.16 Administration Instructions 0..1 text p10.1.17 Dispensing [authority, requirements] 0..1 text p10.1.18 Supply of Study Drug at the Site 0..1 text p10.2 Study Behavioral or Social Intervention(s) 0..1 group Enable When: p1.2 = Social/Behavioral/educational (SBE) (Temporary Codes#SBE) p10.2.1 Administration of Intervention 0..1 text p10.2.2 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 0..1 text p10.2.3 Assessment of participant Compliance with Study Intervention 0..1 text p10.3 Study Procedural Intervention(s) Description 0..1 group p10.3.1 Administration of Procedural Intervention 0..1 text p10.3.2 Procedures for Training of Clinicians on Procedural Intervention 0..1 text p10.3.3 Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention 0..1 text p10.3.3_help Define how adherence to the protocol (e.g., administration of study intervention, use of device,) will be assessed, and verified (if applicable, e.g., plasma assays, electronic monitoring devices, daily diaries). Include a discussion of what documents are mandatory to complete (e.g., participant drug log) and what source documents/records will be used to calculate study intervention compliance. 0..1 display p10.4 Participant Compliance and Monitoring 0..1 text p10.5 Study Intervention/Experimental Manipulation Adherence 0..1 text p11 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal 0..1 group p11.1 Discontinuation of Study Intervention 0..1 text p11.1_help Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the study. This section should state which adverse events would result in discontinuation of study intervention or participant discontinuation/withdrawal. In addition, participants may discontinue the study intervention, but remain in the study for follow-up, especially for safety and efficacy study endpoints (if applicable). A Case Report Form (CRF) should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal. 0..1 display p11.2 Participant withdrawal and Termination 0..1 group p11.2.1 Reasons for Withdrawal or Termination 0..1 text p11.2.2 Handling of Participant Withdrawal or Termination 0..1 text p11.2.3 Replacement of participants 0..1 text p11.3 Lost to Follow-Up 0..1 text p11.3_help The protocol should describe the nature and duration of study follow-up. Participants are considered lost to follow-up when they stop reporting to scheduled study visits and cannot be reached to complete all protocol-required study procedures. Describe the plans to minimize loss to follow-up and missing data. 0..1 display p12 Study Procedures 0..1 group p12.1 Study Procedures/Evaluations 0..1 group p12.1.1 Study Specific Procedures 0..1 text p12.1.2 Standard of Care Study Procedures 0..1 text p12.2 Laboratory Procedures/Evaluations 0..1 group p12.2.1 Clinical Laboratory Evaluations 0..1 text p12.2.2 Research Laboratory Evaluations 0..1 text p12.2.3 Other Assays or Procedures 0..1 text p12.2.4 Specimen Preparation, Handling, and Storage 0..1 text p12.2.5 Specimen Shipment 0..1 text p12.3 Data Collection and Follow Up for Withdrawn participants 0..1 text p12.4 Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception). 0..1 text p12.5 Precautionary Medications, Treatments, and Procedures 0..1 text p12.6 Prohibited Medications, Treatments, and Procedures 0..1 text p12.7 Prophylactic Medications, Treatments, and Procedures 0..1 text p12.8 Rescue Medications, Treatments, and Procedures 0..1 text p12.8_help List all medications, treatments, and/or procedures that may be provided during the study for "rescue therapy" and relevant instructions about administration of rescue medications. 0..1 display p12.9 Participant Access to Study Agent at Study Closure 0..1 text p12.10 Concomitant Medications, Treatments , and Procedures 0..1 text p12.10_help This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed. Describe the data that will be recorded related to permitted concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures. Include details about when the information will be collected (e.g., screening, all study visits). Describe how allowed concomitant therapy might affect the outcome (e.g., drug-drug interaction, direct effects on the study endpoints) and how the independent effects of concomitant and study interventions could be ascertained. 0..1 display p13 Schedule of Study Procedures 0..1 group p13.1 Screening 0..1 text p13.2 Enrollment/Visit 1/Baseline Visit 0..1 text p13.3 Intermediate Visits 0..* text p13.4 Final Study Visit 0..1 text p13.5 Withdrawal/Early Termination Visit 0..1 text p13.6 Unscheduled Visit 0..1 text p13.7 Follow Up Phase of the Study 0..1 group p13.7.1 Visit 0..* text p13.7.2 End of Study Visit 0..1 text p13.15 Schedule of Study Procedures Attachments 0..* group p13.15_help Attachments regarding the Schedule of Study Procedures can be attached here. 0..1 display p13.15.1 Describe the file that is being attached (optional) 0..1 string p13.15.2 Attachment 0..1 attachment p14 Assessment of Safety 0..1 group p14_help Assessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants, the risks of the study intervention, and other study procedures and the characteristics of the study population (e.g., vulnerable populations such as children). 0..1 display p14.1 Specification of Safety Parameters 0..1 group p14.1.1 Definition of Adverse Events(AE) 0..1 text p14.1.1_help Provide the definition of an AE being used for the clinical trial. 0..1 display p14.1.2 Definition of Serious Adverse Events (SAE) 0..1 text p14.1.2_help Provide the definition of an SAE being used for the clinical trial. 0..1 display p14.1.3 Definition of Unanticipated Problems 0..1 text p14.1.3_help This includes any incident or outcome that is not expected in terms of nature, frequency, or severity related to the research procedures and participants. 0..1 display p14.2 Classification of an Adverse Event 0..1 group p14.2.1 Severity of an Event 0..1 text p14.2.1_help All AEs are assessed by the study clinician using a protocol defined grading system. Describe the method of grading an AE for severity. For example, many toxicity tables are available for use and are adaptable to various study designs. 0..1 display p14.2.2 Relationship to Study Intervention/Experimental Manipulation 0..1 text p14.2.2_help Description of the method of determining the relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. Some protocols may use a binary assessment (related/not related); others may have a scale of relatedness. 0..1 display p14.2.3 Expectedness 0..1 text p14.2.3_help Description of an adverse event, the nature or severity is not in Investigator Brochure or has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere 0..1 display p14.3 Time Period and Frequencey for Event Assessment and Follow-Up 0..1 text p14.4 Reporting Procedures 0..1 group p14.4.1 Notifying the IRB 0..1 group p14.4.1.1 Adverse Event Reporting 0..1 text p14.4.1.1_help Description of the AE reporting procedures, including timeframes 0..1 display p14.4.1.2 Serious Adverse Event Reporting 0..1 text p14.4.1.2_help Description of the SAE reporting procedures, including timeframes 0..1 display p14.4.1.3 Unanticipated Problem Reporting 0..1 text p14.4.1.3_help This section addresses responsibilities of investigators for reporting of UPs. Describe the UP reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., DSMB, safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the UP report forms. Institutions engaged in human subjects research conducted or supported by Department of Health and Human Services (DHHS) must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others (45 CFR 46.103(b)(5)). Furthermore, for research covered by an assurance approved for federal wide use by OHRP, DHHS regulations at 45 CFR 46.103(a) require that institutions promptly report any unanticipated problems to OHRP. Refer to the Reportable Events guidance in IRBear for further details. 0..1 display p14.4.1.4 Reporting of Pregnancy 0..1 text p14.4.1.4_help State the study's pregnancy-related policy and procedure. Include appropriate mechanisms for reporting to the DCC or NIH, the IND or IDE sponsor, study leadership, IRB, and regulatory agencies. Provide appropriate modifications to study procedures (e.g., discontinuation of study intervention, while continuing safety follow-up, requesting permission to follow pregnant women to pregnancy outcome). 0..1 display p14.4.2 Notifyiing the Study Sponsor 0..1 text p14.4.3 Notifying the FDA 0..1 text p14.4.4 Notifying Participating Investigators 0..1 text p14.4.5 Reporting Events to Participants 0..1 text p14.4.5_help Describe how participants will be informed about AEs and SAEs, and study-related results on an individual or aggregate level. In addition, describe plans for detecting and managing incidental findings associated with study procedures 0..1 display p14.4.6 Events of Special Interest 0..1 text p14.4.6_help Describe any other events that merit reporting to the sponsor, study leadership, IRB, and regulatory agencies. For example, in oncology trials, secondary malignancies are often captured. 0..1 display p14.5 Follow Up Report 0..1 text p14.6 Study Halting/Stopping Rules 0..1 text p15 Statistical Considerations 0..1 group p15.1 Statistical and Analytical Plans(SAP) 0..1 text p15.2 Statistical Hypotheses 0..1 text p15.2_help State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, specifying the type of comparison (e.g., superiority, equivalence or non-inferiority, dose response) and time period for which each endpoint will be analyzed. 0..1 display p15.3 Analysis Datasets 0..1 text p15.3_help Clearly identify and describe the analysis datasets (e.g., which participants will be included in each). 0..1 display p15.4 Populations for Analysis 0..1 text p15.5 Sample Size Determination 0..1 text p15.5_help Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate and judge the feasibility of enrolling and following the necessary number of participants. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses (e.g., sub analyses or moderator analyses involving an interaction term) 0..1 display p15.6 Description of Statistical Methods 0..1 group p15.6.1 General Approach 0..1 text p15.6.2 Analysis of Primary Efficacy Endpoints(s) 0..1 text p15.6.3 Analysis of Secondary Endpoint(s) 0..1 text p15.6.4 Safety Analyses 0..1 text p15.6.4_help Describe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). The information included here should be consistent with the information contained within Assessment of Safety section. 0..1 display p15.6.5 Adherence and Retention Analyses 0..1 text p15.6.6 Baseline Descriptive Statistics 0..1 text p15.6.7 Planned Interim Analyses 0..1 group p15.6.7.1 Safety Review 0..1 text p15.6.7.2 Efficacy Review 0..1 text p15.6.8 Additional Sub-Group Analyses 0..1 text p15.6.9 Multiple Comparison/Multiplicity 0..1 text p15.6.10 Tabulation of Individual Response Data 0..1 text p15.6.11 Exploratory Analyses 0..1 text p15.6.12 Pharmacokinetic Analysis (if applicable) 0..1 text p15.7 Sample Size 0..1 text p15.7_help Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants.Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses. 0..1 display p15.8 Measures to Minimize Bias 0..1 group p15.8.1 Enrollment/Randomization/Masking Procedures 0..1 text p15.8.2 Evaluation of Success of Blinding 0..1 text p15.8.3 Breaking the Study Blind/Participant Code 0..1 text p16 Supporting Documentation and Operational Considerations 0..1 group p16.1 Regulatory, Ethical and Study Oversight Considerations 0..1 group p16.1.1 Protocol Amendments 0..1 text p16.1.2 Ethical Standard 0..1 text p16.1.3 Institutional Review Board 0..1 text p16.1.4 Informed Consent Process 0..1 group p16.1.4.1 Consent/Assent and Other Informational Documents Provided to Participants 0..1 text p16.1.4.2 Consent Procedures and Documentation 0..1 group p16.1.4.2.1 Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research 0..1 text p16.1.4.2.2 Describe the parental permission process and the child assent process. (If study involves children) 0..1 text p16.1.4.2.3 Some participants may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals 0..1 text p16.1.4.2.4 Methods of Informed Consent for non-English Speakers 0..1 text p16.1.4.2.5 Waiver or Alteration of Consent Process 0..1 text p16.1.4.2.6 HIPAA Authorization 0..1 group p16.1.4.2.6.1 Participant's Capacity to Give Legally Effective Consent 0..1 text p16.1.4.3 Indicate where the consent process will take place. 0..1 text p16.1.5 Participant data and Confidentialty 0..1 group p16.1.5.1 Research Use of Stored Human Samples, Specimens, or Data 0..1 text p16.1.5.2 Confidentiality of Research Biospeciemen/Data 0..1 text p16.1.5.3 Certificate of Confidentiality (if applicable) 0..1 text p16.1.5.4 Provisions to Protect the Privacy of Participants 0..1 text p16.1.6 Future Use of Stored Human Specimens and Data 0..1 text p16.1.7 Study Discontinuation and Closure 0..1 text p16.1.8 Key Roles and Expertise of Study Team 0..* group p16.1.8.1 First Name 0..1 string p16.1.8.1_help First or given name 0..1 display p16.1.8.2 Last Name 0..1 string p16.1.8.2_help Surname or family name 0..1 display p16.1.8.3 Position/Title 0..1 string p16.1.8.4 Responsibilities 0..1 text p16.1.8_help Provide a list of persons, companies, and/or groups serving in key roles in the conduct or oversight of the trial. This should include the sponsormedical expert for the trial (medical monitor), investigator responsible for conducting the trial (principal investigator (PI)), qualified clinician responsible for the siteclinical decisions (site investigator), and any clinical laboratory(ies) or other institutions involved in the trial. Other key roles may include the NIH point of contact (program director or officer), regulatory specialist, biostatistician, data coordinating center (DCC), data management center, data manager, or industry partner. 0..1 display p16.1.9 Safety Oversight 0..1 text p16.1.10 Clinical Monitoring 0..1 text p16.1.11 Quality Assurance and Quality Control 0..1 text p16.1.12 Data Handling and Record Keeping 0..1 group p16.1.12.1 Data Quality Control and Reporting 0..1 text p16.1.12.2 Data Collection and Management Responsibilities 0..1 text p16.1.12.3 Data Archival 0..1 text p16.1.12.4 Study Records Retention 0..1 group p16.1.12.4.1 Photographs, Audio/Video Recordings Retention 0..1 text p16.1.12.4.2 Data and/or Biological Specimens Access 0..1 text p16.1.12.4.3 Data and/or Biological Specimens Retention/Banking 0..1 text p16.1.13 Protocol Deviations 0..1 text p16.1.14 Publication and Data Sharing Policy 0..1 text p16.1.15 Conflict of Interest Policy 0..1 text p16.1.16 Source Documents and Access to Source Data/Documents 0..1 text p16.1.17 Collections of Photographs, or Audio/Video Recording 0..1 text p16.2 Prior Approvals/Attachments Requiring Signatures 0..1 group p16.2.1 Prior Approvals/Attachments Requiring Signatures 0..1 text p16.2.2 Attachment 0..1 attachment p16.2.2_help Attach any prior approvals or documents requiring signatures 0..1 display p16.3 Additional Considerations 0..1 text p16.4 Abbreviations and Special Terms 0..1 text p16.5 Other Supporting Documentation and Operational Considerations Attachments 0..* group p16.5.1 Describe the file that is being attached (optional) 0..1 string p16.5.2 Attachment 0..1 attachment p16.5.2_help Other supporting documentation or operational consideration documentation can be attached here, if relevant 0..1 display p17 Study Administration 0..1 group p17.1 Setting 0..1 group p17.1.1 Describe the sites / locations where your research team will conduct the research 0..1 text p17.2 Registration 0..1 group p17.2.1 Describe the steps the research team will take to ensure that a participant is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.) 0..1 text p17.3 Resources Available 0..1 group p17.3.1 Describe the roles/tasks of each research team member 0..1 text p17.3.2 Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead 0..1 text p17.3.3 Describe the coverage plan to address any issues (including participant safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI 0..1 text p17.3.4 Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities 0..1 text p17.3.5 Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study? 0..1 choice Options: 2 options p17.4 IRB Review 0..1 group p17.4.1 An appropriate IRB , registered with the OHRP ,review and approve this study. 0..1 choice Options: 2 options p17.4.2 Any amendments to the protocol or informed consent documents will be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to participants? 0..1 choice Options: 2 options p17.5 Community-Based Participatory Research/Field Research 0..1 group p17.5.1 Can or will this study involve community-based participatory research? 0..1 choice Options: 2 options p17.5.2 Community-based participatory research 0..1 group Enable When: p17.5.1 = Yes (expandedYes-NoIndicator#Y) p17.5.2.1 Describe the communities that will be involved in this research 0..1 text p17.5.2.2 Describe the composition and involvement of any community advisory board 0..1 text p17.5.2.3 Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research 0..1 text p17.5.2.4 Describe the plans on dissemination and publication of study results which are in agreement with the community 0..1 text p17.6 Multi Site Research 0..1 group p17.6.1 Describe the plan for tracking IRB approval of documents and consent forms for each site 0..1 text p17.6.2 Name of the sponsor(s) and Contract Research Organization (CRO) 0..1 group ExternalDataFor_p17.6.2.1 External Data For linkId p17.6.2.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value p17.6.2.1 Name of the sponsor(s) 0..* open-choice p17.6.2.2 Name of the Contract Research Organization (CRO) 0..1 string Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'CRO').item.where(linkId = 'in5.2').answer.value p17.6.3 Describe the training that will be provided to the enrolling sites staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented 0..1 text p17.6.4 Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites 0..1 text p17.6.5 Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms 0..1 text p17.6.6 Describe the plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed). If available, please provide the Data Sharing Plan or Policy 0..1 text p17.6.7 Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations 0..1 group p17.6.7.1 Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.) 0..1 text p17.6.7.2 Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail? 0..1 text p17.6.8 Describe the plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA) 0..1 text p17.6.9 Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable) 0..1 group p17.6.9.1 Describe how they will be provided to each enrolling site 0..1 text p17.6.9.2 Describe how dispensing will be monitored 0..1 text p17.6.9.3 Describe what investigational product accountability procedures will be implemented 0..1 text p17.6.10 Describe the procedures for study closures and early site termination 0..1 text p17.6.11 Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution) 0..1 text p17.7 Key Roles and Study Governance 0..1 text p18 Study Finances 0..1 group p18.1 Funding Source 0..1 text p18.2 Costs to the participant 0..1 text p18.3 Participant Reimbursements or Payments 0..1 text p18.4 Compensation for Research-Related Injury 0..1 text p19 References 0..1 group p19.1 List any references here, unless already cited. 0..1 text p19.2 Reference list attachment (optional) 0..1 group p19.2.1 Describe the file that is being attached (optional) 0..1 string p19.2.2 Attachment 0..1 attachment p19.2_help Reference list can be attached here 0..1 display p25 Other Attachments to the Protocol 0..1 group p25.1 Other Attachment(s) to the Protocol 0..* group p25.1.1 Describe the file that is being attached 0..1 string p25.1.2 Attachment 0..1 attachment p25.1_help Attach any other relevant materials here, if not attached in other sections of the form 0..1 display ADMIN00 Administrative Use Only 0..1 group ADMIN01 Link ID prefix 0..1 string Initial Value: string = p ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value ADMIN04 Questionnaire Response ID of the local considerations Questionnaire Response, if any 0..1 string Documentation for this format Option Sets Answer options for p1.1 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational") Answer options for p1.2 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DBV ("Drug/Biologic/Vaccine") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEV ("Device") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SBE ("Social/Behavioral/educational (SBE)") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRO ("Procedural") Answer options for p1.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p1.30 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p1.4 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE") Answer options for p1.7 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p1.8.1 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COPI ("Co-Principal Investigator") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COI ("Co-Investigator") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PD ("Program Director") Answer options for p3.1.8 http://terminology.hl7.org/CodeSystem/research-study-phase#phase-2 ("Phase 2") http://terminology.hl7.org/CodeSystem/research-study-phase#phase-3 ("Phase 3") http://terminology.hl7.org/CodeSystem/research-study-phase#phase-4 ("Phase 4") Answer options for p4.1.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p4.1.7 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p4.1.8.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p4.1.8.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p4.3.1.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.2.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.2.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.31.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.31.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.31.7 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.31.8 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.5.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.5.3.8 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.8 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.9.12 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.10 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.11.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.12 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.13.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.14 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.15.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p9.1.7.15.7.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p17.3.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p17.4.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p17.4.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for p17.5.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
The content of the Questionnaire Response transferred to this Questionnaire during form launch
The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
variable to store the incoming data from the launchContext extension for populate and other expressions
%resource.item.item.where(linkId = 'p1.4').answer.value.code
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding
Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding
Does this protocol require a FDA exemption?
%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
Is an IND or IDE being used in this study?
Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?
%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
Select Investigational New Drug (IND) or Investigational Device Exemption (IDE)
%lookupInitiateStudy.descendants().where(linkId = 'in1.1').answer.value
The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)
%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
A short study title written in language intended for the lay public.
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
First or given name of the lead principal investigator
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
Professional and Academic degrees of the lead principal investigator
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value
10-digit phone number, including area code
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm
Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.
First or given name of the additional investigator
Professional and Academic degrees of the additional investigator
%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
Provided by the sIRB. Will not be available at the time of initial submission.
%lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression).
Sponsor Selected for this repetition of the repeating group
item.where(linkId = 'p1.10.1.1').answer.valueCoding.display
%resource.repeat(item).where(linkId = 'ExternalDataFor_p1.10.1.1').answer.value
%lookupInitiateStudy.item.where(linkId = 'in5' and item.where(answer.valueString = %sponsorSelectedThisRepetition)).item.where(linkId = 'in5.4').answer.valueString
Unique Protocol Identification Number used by the sponsor.
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
iif(%typeExemptionIDEIDN = 'IND', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
iif(%typeExemptionIDEIDN = 'IDE', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
Generic, followed by marketed name if applicable
Funding Organization(s), Address and Contact Information
item.where(linkId = 'p1.18.2.1').answer.valueCoding.display
%resource.repeat(item).where(linkId = 'ExternalDataFor_p1.18.1.1').answer.value
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %fundingOrgName)).item.where(linkId = 'in5.3').answer.value
Sponsor(s), Address and Contact Information
item.where(linkId = 'p1.19.1').answer.valueCoding.display
%resource.repeat(item).where(linkId = 'ExternalDataFor_p1.19.1.1').answer.value
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %sponsorOrgNameSelectedThisRepetition)).item.where(linkId = 'in5.3').answer.value
Individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation.
First or given name of the medical monitor
Professional and Academic degrees of the medical monitor
Protocol Amendment Summary of Changes Table
[Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be IRB-approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.]
Select one of the two statements below. If the study is an intramural NIH study, use the second statement below
%resource.item.item.where(linkId = 'p1.5').answer.value
%resource.item.item.where(linkId = 'p1.6').answer.value
Short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length. A detailed schematic describing all visits and a schedule of assessments should be included in the Schema and Schedule of Activities
Include the primary and secondary objectives.Theseobjectives should be thesame as the objectives contained in the body of the protocol. These align with Primary Purpose in clinicaltrials.gov
Primary endpoint and secondary endpoints.These endpoints should be the same as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov
Accrual Ceiling/Number of Participants (projected-for all sites)
The total number of subjects expected to complete the study. This includes expected sample size and estimated ineligible persons after signing a screening consent.
Specify sample size, gender, age, demographic group, general health status, and geographic location.
Description of Sites/Facilities Enrolling Participants
Brief description of planned facilities/participating sites enrolling participants. Indicate number of sites and if the study is intended to include sites outside the United States.
Description of Study Intervention ( Agent/Procedure)/Investigational Product
Describe the study intervention. If the study interventionis a drug or biologic, include dose and route of administration. For devices,provide a description ofeach important component, ingredient,property and the principle of operation of the device.
Estimated time (in months) from when the study opens to enrollment until completion of data analyses
Time (e.g., in months) it will take for each individual participant to complete all participant visits.
Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc.
Duration of Investigational Product Administration
Total duration of investigational product administration (including any open-label lead-in, if applicable).
Procedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws)
Entire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section.
Note if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo
A very brief description of the main elements of the statistical methodology to be used in the study. Limit this section to discussion of the analysis of the primary endpoint and perhaps the main secondary endpoint.
This section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.) The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 +/- 7; etc.
This section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.) The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 ±7; etc.
Describe the schedule of activities in the text box here or attach a copy of the Schedule of Activities below.
Describe the file that is being attached (optional)
The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment. Either describe in the text box here or attach a copy of the Schedule of Activities.
Introduction, Background Information and Scientific Rational
Describe the relevant literature and the specific gaps in current knowledge that this study intends to address
Gaps that this study intends to address based on literature
Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge
Based on the existing literature and how it will add to existing knowledge
Describe the relevance and usefulness of the objectives
Is this the first time the study drug, device, or intervention/procedure will be used in humans.
If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date
Details If the intervention/drug/device is not the first time used.
In this section include the name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable.
Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment
Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study.
Is the active control an established effective intervention?
If no, clarify how it is ethically justified to use this control in the study
The problems or question and reason for conducting the study. E.g. explain the population, disease, standard of care (if there is one), and limitations of knowledge or available therapy.
List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks
State which study interventions may have unknown risks
State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant
Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community
Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?
Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.)
Describe the procedures that will be put in place to minimize these risks
Describe how these procedures are adequate for the location where study procedures will be performed
Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits
Note: Payments and incentives are not considered benbefits.
Describe any benefit to the population from which the participant is drawn
Describe any benefit to science, society, and humanity in general
Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.)
Describe the standard clinical care that may be an alternative
Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting
Other alternatives to study participation
Study Purpose, Objectives or Specific Aims
Describe the purpose, specific aims, or objectives of the study
The main question the study seeks to answer.
The secondary objective(s) are goals that will provide further information on the use of the intervention.
Tertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research.
Precise definitions of the study endpoints and criteria for evaluation
Description of primary endpoints identified in the primary Study Protocol.
Briefly explain why the endpoint(s) were chosen.
Exploratory endpoints should be specified. Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses.
Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.
The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design should be consistent with the Protocol Synopsis and Protocol Schema.
Describe the rationale for the type and selection of control (e.g. placebo, active drug, dose-response, historical) and study design (e.g., non-inferiority as opposed to superiority). Discuss known or potential problems associated with the control chosen in light of the specific disease and intervention(s) being studied.
Provide a justification for the route of administration, planned maximum dosage, and dosing regimen, including starting dose, of the study intervention(s) and control product(s).
A clinical trial is considered completed when participants are no longer being examined or the last participant's last study visit has occurred.
Attach documents related to the Study Design here such as Study Intervention Activities descriptions, Follow Up plans and Study/Data Collection Instruments
Describe the file that is being attached
Category/Group (eg. Adults, controls, parents, children)
Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)
Number Expected to Complete the Study or Needed to Address the Research Question
Overall study sample size (if multisite)
Description of criteria that define participants to include in study
Description of criteria that define participants to exclude in study
Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination)
State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study
Can study participants participate in another research study while participating in this research study
Participants who are consented to participate in the clinical trial, who do not meet one or more criteria required for participation in the trial during the screening procedures, are considered screen failures. Indicate how screen failures will be handled in the trial, including conditions and criteria upon which re-screening is acceptable, when applicable.
Describe any restrictions during any parts of the study pertaining to lifestyle and/or diet (e.g., food and drink restrictions, timing of meals relative to dosing, intake of caffeine, alcohol, or tobacco, or limits on activity), and considerations for household contacts. Describe what action will be taken if prohibited medications, treatments or procedures are indicated for care (e.g., early withdrawal).
Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses
Are there any risk to the fetus from the study interventions or procedures.
Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus
If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means
Describe the biomedical knowledge that is expected to result from this research for this population
Describe how any risk of this research is the least possible for achieving the objectives of the research
Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate
Can or will the research involve neonates of uncertain viability or non-viable neonates?
Research involving neonates of uncertain viability or non-viable neonates
Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates
Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means
Describe whether there will be added risk to the neonate resulting from the research
Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate
No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study
Individuals engaged in the research will have no part in determining the viability of a neonate
For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate
For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective
Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?
Enrollment of participants who are not yet adults (neonates, children, teenagers)
I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years).
If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined
Describe how permission to participate in the study will be obtained from the parents or legal guardians
Describe waiting period between informing the prospective participant and obtaining the assent
Describe any process to ensure ongoing assent
Describe Research team members involved in the assent process
Describe how long children will have to consider study participation
Describe steps that will be taken to minimize the possibility of coercion or undue influence
Describe steps that will be taken to ensure the participants's understanding
If assent will not be obtained from children, specify why
Will children reach 18 years of age while in the study?
Children reaching 18 years of age while in the study
Describe the plan to obtain written informed consent from the participant at age 18 years
Describe who will be responsible for managing the plan
Describe where the consent discussion will take place
Describe what will happen if the participant cannot be located to provide consent at age 18 years
Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child?
Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child.
Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate
Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making
Describe any additional steps or procedures that will be used when performing informed consent with this population
Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?
Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent
Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context
Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent
Describe the process to determine whether or not the individual is capable of consent
Describe who will determine if the participant is able to provide informed consent
Describe how it will be determined whether the participant is able to provide informed consent
Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent
List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.)
If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent
Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not
If assent will not be obtained from some or all participants, an explanation of why not
Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents
Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use
Participants will be withdrawn if they appear to be unduly distressed at any time during the study.
Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired
Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers
Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project
Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.
If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact
Can or will students and/or employees be enrolled in this research?
Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees
Describe how potential coercion will be eliminated
Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that
Describe additional safeguards included to protect the rights and welfare of students and employees
Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee
Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized.
Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)?
Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody).
Describe the justification for recruiting and enrolling this population
Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that
Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that
Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research
Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian
Is the study is greater than minimal risk?
Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards
Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis
Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research
The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.
Strategies for Recruitment and Retention
Describe when, where, and how potential participants will be recruited
Provide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire.
When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).
Describe source of participants (for example, patient population, local community, etc.)
Describe methods that will be used to identify potential participants
Describe how the recruitment methods described will be effective in attracting the targeted participant population
Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.)
State how the study intervention and control product will be provided to the investigator, including who will be supplying the investigational product and any other protocol dictated medications/devices. If investigational product(s) will be purchased through commercial sources, state this.
Study Agent Accountability/ Return or Destruction of Investigational Product
Describe plans about how and by whom the study intervention will be distributed, including participation of a drug repository or pharmacy, and plans for disposal of expired or return of unused product.
Formulation and appearance of Control Product
Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.
Formulation and appearance of Test Product
Describe the packaging and labeling of the study intervention and control product, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling.
Describe storage and stability requirements (e.g., protection from light, temperature, humidity) for the study intervention and control product. For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken).
Description of the preparation of the study intervention and control product, including any preparation required by study staff and/or study participants. Include thawing, diluting, mixing, and reconstitution/preparation instructions, as appropriate. For devices, include any relevant assembly or use instructions.
Describe the procedures for selecting each participant's dose of study intervention and control product. For drugs, that includes the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time study participants will be administered the study intervention), the planned route of administration (e.g., oral, nasal, intramuscular), and the relation of dosing to meals.
Starting Dose and Dose Escalation Schedule
State the starting dose and schedule of the study intervention and control product, including the maximum and minimum duration for those participants who continue in the study. For example, in some oncology trials for participants with no available therapeutic alternatives, intervention continues even after disease progression. In this instance, consider alternative designs that enable participants to rollover to a continued treatment arm and include appropriate instructions to guide this implementation.
Study Behavioral or Social Intervention(s)
Procedures for Training Interventionalists and Monitoring Intervention Fidelity
Assessment of participant Compliance with Study Intervention
Study Procedural Intervention(s) Description
Administration of Procedural Intervention
Procedures for Training of Clinicians on Procedural Intervention
Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention
Define how adherence to the protocol (e.g., administration of study intervention, use of device,) will be assessed, and verified (if applicable, e.g., plasma assays, electronic monitoring devices, daily diaries). Include a discussion of what documents are mandatory to complete (e.g., participant drug log) and what source documents/records will be used to calculate study intervention compliance.
Study Intervention/Experimental Manipulation Adherence
Study Intervention Discontinuation and Participant Discontinuation/Withdrawal
Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the study. This section should state which adverse events would result in discontinuation of study intervention or participant discontinuation/withdrawal. In addition, participants may discontinue the study intervention, but remain in the study for follow-up, especially for safety and efficacy study endpoints (if applicable). A Case Report Form (CRF) should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal.
Handling of Participant Withdrawal or Termination
The protocol should describe the nature and duration of study follow-up. Participants are considered lost to follow-up when they stop reporting to scheduled study visits and cannot be reached to complete all protocol-required study procedures. Describe the plans to minimize loss to follow-up and missing data.
Specimen Preparation, Handling, and Storage
Data Collection and Follow Up for Withdrawn participants
Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).
Precautionary Medications, Treatments, and Procedures
Prohibited Medications, Treatments, and Procedures
Prophylactic Medications, Treatments, and Procedures
Rescue Medications, Treatments, and Procedures
List all medications, treatments, and/or procedures that may be provided during the study for "rescue therapy" and relevant instructions about administration of rescue medications.
Participant Access to Study Agent at Study Closure
Concomitant Medications, Treatments , and Procedures
This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed. Describe the data that will be recorded related to permitted concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures. Include details about when the information will be collected (e.g., screening, all study visits). Describe how allowed concomitant therapy might affect the outcome (e.g., drug-drug interaction, direct effects on the study endpoints) and how the independent effects of concomitant and study interventions could be ascertained.
Schedule of Study Procedures Attachments
Attachments regarding the Schedule of Study Procedures can be attached here.
Assessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants, the risks of the study intervention, and other study procedures and the characteristics of the study population (e.g., vulnerable populations such as children).
Provide the definition of an AE being used for the clinical trial.
Definition of Serious Adverse Events (SAE)
Provide the definition of an SAE being used for the clinical trial.
This includes any incident or outcome that is not expected in terms of nature, frequency, or severity related to the research procedures and participants.
All AEs are assessed by the study clinician using a protocol defined grading system. Describe the method of grading an AE for severity. For example, many toxicity tables are available for use and are adaptable to various study designs.
Relationship to Study Intervention/Experimental Manipulation
Description of the method of determining the relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. Some protocols may use a binary assessment (related/not related); others may have a scale of relatedness.
Description of an adverse event, the nature or severity is not in Investigator Brochure or has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere
Time Period and Frequencey for Event Assessment and Follow-Up
Description of the AE reporting procedures, including timeframes
Description of the SAE reporting procedures, including timeframes
This section addresses responsibilities of investigators for reporting of UPs. Describe the UP reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., DSMB, safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the UP report forms. Institutions engaged in human subjects research conducted or supported by Department of Health and Human Services (DHHS) must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others (45 CFR 46.103(b)(5)). Furthermore, for research covered by an assurance approved for federal wide use by OHRP, DHHS regulations at 45 CFR 46.103(a) require that institutions promptly report any unanticipated problems to OHRP. Refer to the Reportable Events guidance in IRBear for further details.
State the study's pregnancy-related policy and procedure. Include appropriate mechanisms for reporting to the DCC or NIH, the IND or IDE sponsor, study leadership, IRB, and regulatory agencies. Provide appropriate modifications to study procedures (e.g., discontinuation of study intervention, while continuing safety follow-up, requesting permission to follow pregnant women to pregnancy outcome).
Describe how participants will be informed about AEs and SAEs, and study-related results on an individual or aggregate level. In addition, describe plans for detecting and managing incidental findings associated with study procedures
Describe any other events that merit reporting to the sponsor, study leadership, IRB, and regulatory agencies. For example, in oncology trials, secondary malignancies are often captured.
State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, specifying the type of comparison (e.g., superiority, equivalence or non-inferiority, dose response) and time period for which each endpoint will be analyzed.
Clearly identify and describe the analysis datasets (e.g., which participants will be included in each).
Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate and judge the feasibility of enrolling and following the necessary number of participants. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses (e.g., sub analyses or moderator analyses involving an interaction term)
Analysis of Primary Efficacy Endpoints(s)
Describe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). The information included here should be consistent with the information contained within Assessment of Safety section.
Pharmacokinetic Analysis (if applicable)
Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants.Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses.
Enrollment/Randomization/Masking Procedures
Breaking the Study Blind/Participant Code
Supporting Documentation and Operational Considerations
Regulatory, Ethical and Study Oversight Considerations
Consent/Assent and Other Informational Documents Provided to Participants
Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research
Describe the parental permission process and the child assent process. (If study involves children)
Some participants may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals
Methods of Informed Consent for non-English Speakers
Participant's Capacity to Give Legally Effective Consent
Indicate where the consent process will take place.
Research Use of Stored Human Samples, Specimens, or Data
Confidentiality of Research Biospeciemen/Data
Certificate of Confidentiality (if applicable)
Provisions to Protect the Privacy of Participants
Future Use of Stored Human Specimens and Data
Provide a list of persons, companies, and/or groups serving in key roles in the conduct or oversight of the trial. This should include the sponsormedical expert for the trial (medical monitor), investigator responsible for conducting the trial (principal investigator (PI)), qualified clinician responsible for the siteclinical decisions (site investigator), and any clinical laboratory(ies) or other institutions involved in the trial. Other key roles may include the NIH point of contact (program director or officer), regulatory specialist, biostatistician, data coordinating center (DCC), data management center, data manager, or industry partner.
Data Collection and Management Responsibilities
Photographs, Audio/Video Recordings Retention
Data and/or Biological Specimens Retention/Banking
Source Documents and Access to Source Data/Documents
Collections of Photographs, or Audio/Video Recording
Prior Approvals/Attachments Requiring Signatures
Attach any prior approvals or documents requiring signatures
Other Supporting Documentation and Operational Considerations Attachments
Other supporting documentation or operational consideration documentation can be attached here, if relevant
Describe the sites / locations where your research team will conduct the research
Describe the steps the research team will take to ensure that a participant is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.)
Describe the roles/tasks of each research team member
Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead
Describe the coverage plan to address any issues (including participant safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI
Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities
Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?
An appropriate IRB , registered with the OHRP ,review and approve this study.
Any amendments to the protocol or informed consent documents will be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to participants?
Community-Based Participatory Research/Field Research
Can or will this study involve community-based participatory research?
Describe the communities that will be involved in this research
Describe the composition and involvement of any community advisory board
Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research
Describe the plans on dissemination and publication of study results which are in agreement with the community
Describe the plan for tracking IRB approval of documents and consent forms for each site
Name of the sponsor(s) and Contract Research Organization (CRO)
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Name of the Contract Research Organization (CRO)
Describe the training that will be provided to the enrolling sites staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented
Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites
Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms
Describe the plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed). If available, please provide the Data Sharing Plan or Policy
Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations
Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.)
Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?
Describe the plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA)
Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable)
Describe how they will be provided to each enrolling site
Describe how dispensing will be monitored
Describe what investigational product accountability procedures will be implemented
Describe the procedures for study closures and early site termination
Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution)
Compensation for Research-Related Injury
List any references here, unless already cited.
Attach any other relevant materials here, if not attached in other sections of the form
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Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
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ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any
Questionnaire Response ID of the local considerations Questionnaire Response, if any