LinkId Text Definition Answer protocol-populate-exampleQR QuestionnaireResponse p1 Research Study p1.1 Study Type Temporary Codes INT: Interventional p1.2 Intervention Temporary Codes DBV: Drug/Biologic/Vaccine p1.3 Does this protocol require a FDA exemption? expandedYes-NoIndicator Y: Yes p1.30 Is an IND or IDE being used in this study? expandedYes-NoIndicator Y: Yes p1.4 Type of exemption Temporary Codes IND: IND p1.5 Study Title A clinical study of the efficacy of Drug A for arthritis p1.6 Study Title (Short) Study of Drug A for arthritis p1.61 Lead Principal Investigator p1.61.1 First Name Jane p1.61.2 Last Name Doe p1.61.8 Degree(s) MD p1.61.3 Department Name Orthopedics p1.61.4 Address p1.61.4.1 Street Address 105 Sample University Ct. p1.61.4.2 City Sample City p1.61.4.3 State NC p1.61.4.4 Zip Code 27612 p1.61.4.5 Country United States p1.61.5 Phone 567-123-1234 p1.61.6 Email drjanedoe@sampleuniversity.edu p1.7 Additional Investigator expandedYes-NoIndicator Y: Yes p1.8 Additional Investigator p1.8.1 Additional Investigator Role Temporary Codes PD: Program Director p1.8.2 First Name [answer] p1.8.3 Last Name [answer] p1.8.8 Suffix [answer] p1.8.9 Degree(s) [answer] p1.8.4 Department Name [answer] p1.8.5 Address p1.8.5.1 Street Address [answer] p1.8.5.2 City [answer] p1.8.5.3 State [answer] p1.8.5.4 Zip Code 12345 p1.8.5.5 Country [answer] p1.8.6 Phone 111-111-11111 p1.8.7 Email [answer] p1.9 IRB Protocol Number PRO098765 p1.10 Sponsor Name(s) and Protocol Number ExternalDataFor_p1.10.1.1 External Data For linkId p1.10.1.1 p1.10.1 Sponsor p1.10.1.1 Sponsor Name [not stated] : National Government Funder p1.10.1.2 Sponsor Protocol Number Gov-123456 p1.10.1 Sponsor p1.10.1.1 Sponsor Name [not stated] : Organization of Arthritis Patients Foundation p1.11 ClinicalTrials.Gov Identifier 12345 p1.12 Grant Title A ClinicalStudy of Drug A for arthritis12345 p1.13 NIH Grant Number 12345 p1.14 IND Number 432fdw512432fqsdf p1.16 Study Product Name Drug A p1.17 Study Product Provider [answer] p1.18 Funding Organization(s), Address and Contact Information ExternalDataFor_p1.18.1.1 External Data For linkId p1.18.1.1 p1.18.1 Funding Organization p1.18.1.1 Name [not stated] : National Government Funder p1.18.1.2 Address p1.18.1.2.1 Street Address [answer] p1.18.1.2.2 City [answer] p1.18.1.2.3 State [answer] p1.18.1.2.4 Zip Code [answer] p1.18.1.2.5 Country [answer] p1.18.1.5 Phone 800-123-1234 p1.18.1.4 Email [answer] p1.18.1 Funding Organization p1.18.1.1 Name [not stated] : Organization of Arthritis Patients Foundation p1.18.1.2 Address p1.18.1.2.1 Street Address [answer] p1.18.1.2.2 City [answer] p1.18.1.2.3 State [answer] p1.18.1.2.4 Zip Code [answer] p1.18.1.2.5 Country [answer] p1.18.1.5 Phone [answer] p1.18.1.4 Email [answer] p1.19 Sponsor(s), Address and Contact Information ExternalDataFor_p1.19.1.1 External Data For linkId p1.19.1.1 p1.19.1 Sponsor p1.19.1.1 Name [not stated] : National Government Funder p1.19.1.3 Address p1.19.1.3.1 Street Address [answer] p1.19.1.3.2 City [answer] p1.19.1.3.3 State [answer] p1.19.1.3.4 Zip Code [answer] p1.19.1.3.5 Country [answer] p1.19.1.4 Email [answer] p1.19.1.5 Phone 800-123-1234 p1.19.1 Sponsor p1.19.1.1 Name [not stated] : Organization of Arthritis Patients Foundation p1.19.1.3 Address p1.19.1.3.1 Street Address [answer] p1.19.1.3.2 City [answer] p1.19.1.3.3 State [answer] p1.19.1.3.4 Zip Code [answer] p1.19.1.3.5 Country [answer] p1.19.1.4 Email [answer] p1.19.1.5 Phone [answer] p1.20 Medical Monitor p1.20.1 First Name [answer] p1.20.2 Last Name [answer] p1.20.6 Suffix [answer] p1.20.7 Degree(s) [answer] p1.20.3 Phone 202-222-2222 p1.20.4 Email [answer] p1.20.5 Address p1.20.5.1 Street Address [answer] p1.20.5.2 City [answer] p1.20.5.3 State [answer] p1.20.5.4 Zip Code 12345 p1.20.5.5 Country [answer] p1.21 Confidentialty Statement [answer] p1.23 Protocol Version Number 12345 p1.24 Protocol Version Date 2022-02-22 p2 Protocol Amendment Summary of Changes Table p2.1 Affected Section(s) [answer] p2.2 Summary of Revisions Made [answer] p2.3 Rationale [answer] p2 Protocol Amendment Summary of Changes Table p2.1 Affected Section(s) [answer] p2.2 Summary of Revisions Made [answer] p2.3 Rationale [answer] p2.4 Statement of Compliance [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.] p3 Protocol Summary p3.1 Synopsis p3.1.1 Title (Full) A clinical study of the efficacy of Drug A for arthritis p3.1.2 Title (Short) Study of Drug A for arthritis p3.1.3 Study Description [answer] p3.1.4 Objectives [answer] p3.1.5 End Points [answer] p3.1.6 Accrual Ceiling/Number of Participants (projected-for all sites) 200 p3.1.7 Study Population [answer] p3.1.8 Phase ResearchStudyPhase phase-2: Phase 2 p3.1.9 Description of Sites/Facilities Enrolling Participants [answer] p3.1.10 Description of Study Intervention ( Agent/Procedure)/Investigational Product [answer] p3.1.11 Study Duration [answer] p3.1.12 Participant Duration 3 months p3.1.13 Methodology [answer] p3.1.14 Duration of Investigational Product Administration [answer] p3.1.15 Key Procedures [answer] p3.1.16 Main Inclusion/Exclusion Criteria [answer] p3.1.17 Reference Therapy [answer] p3.1.18 Statistical Analysis [answer] p3.2 Schema p3.2.1 Attach schema here No display for Attachment p3.3 Schedule of Activities p3.3.1 Schedule of Activities [answer] p3.3.3 Schedule of Activities Attachment p3.3.3.1 Describe the file that is being attached (optional) [answer] p3.3.3.2 Attachment No display for Attachment p4 Introduction, Background Information and Scientific Rational p4.1 Background p4.1.1 Describe the relevant literature and the specific gaps in current knowledge that this study intends to address [answer] 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 [answer] p4.1.3 Describe the relevance and usefulness of the objectives [answer] p4.1.4 Is this the first time the study drug, device, or intervention/procedure will be used in humans. expandedYes-NoIndicator Y: Yes p4.1.6 Investigational Product p4.1.6.1 Name and Description [answer] p4.1.6.2 Preclinical Data [answer] p4.1.6.3 Clinical Data to Date p4.1.6.3.1 Human Pharmacokinetics [answer] p4.1.6.3.2 Clinical Studies in adults [answer] p4.1.7 Is there an active control group? expandedYes-NoIndicator Y: Yes p4.1.8 Active Control Group 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 [answer] 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. expandedYes-NoIndicator Y: Yes p4.1.8.3 Is the active control an established effective intervention? expandedYes-NoIndicator Y: Yes p4.2 Study Rationale [answer] p4.3 Risk/Benefit Assessment p4.3.1 Potential Risks 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 [answer] p4.3.1.2 State which study interventions may have unknown risks [answer] 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 [answer] 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 [answer] 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.):? expandedYes-NoIndicator Y: Yes 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.) p4.3.1.6.1 Describe these risks [answer] p4.3.1.6.2 Describe the procedures that will be put in place to minimize these risks [answer] p4.3.1.6.3 Describe how these procedures are adequate for the location where study procedures will be performed [answer] p4.3.1.7 Other risks [answer] p4.3.2 Potential Benefits 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 [answer] p4.3.2.2 Describe any benefit to the population from which the participant is drawn [answer] p4.3.2.3 Describe any benefit to science, society, and humanity in general [answer] p4.3.2.4 Other benefits [answer] p4.3.3 Alternatives to Study Participation 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.) [answer] p4.3.3.2 Describe the standard clinical care that may be an alternative [answer] p4.3.3.3 Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting [answer] p4.3.3.4 Other alternatives to study participation [answer] p5 Study Purpose, Objectives or Specific Aims p5.1 Hypothesis [answer] p5.2 Primary Objectives [answer] p5.3 Secondary Objectives [answer] p5.4 Tertiary/Exploratory Objectives [answer] p6 Study Endpoints p6.1 Primary Endpoints [answer] p6.1.1 Justification for Endpoints [answer] p6.2 Secondary Endpoints [answer] p6.2.1 Justification for Secondary Endpoints [answer] p6.3 Tertiary Endpoints [answer] p6.3.1 Justification for Tertiary Endpoints [answer] p6.4 Primary Safety endpoints [answer] p6.5 Secondary Safety endpoints [answer] p6.6 Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims. [answer] p7 Study Design p7.1 Overall Design [answer] p7.2 Scientific Rationale for Study Design [answer] p7.3 Justification for Dose [answer] p7.4 Justification for Intervention [answer] p7.5 End of Study Definition [answer] p7.6 Screening Activities [answer] p7.7 Study Intervention Activities [answer] p7.8 Follow Up Activities [answer] p7.9 Allocation to Interventional Group [answer] p7.10 Study/Data Collection Instruments [answer] p7.11 Research Setting [answer] p7.15 Study Design Attachments p7.15.1 Describe the file that is being attached [answer] p7.15.2 Attachment No display for Attachment p8 Study Population p8.1 Participant Selection p8.1.2 Age Range [answer] p8.1.3 Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures) 150 p8.1.4 Number Expected to Complete the Study or Needed to Address the Research Question 100 p8.1.5 Total Number of participants 200 p8.1.6 Overall study sample size (if multisite) 500 p9 Study Enrollment and Withdrawal p9.1 Eligibility Criteria p9.1.1 Inclusion and Exclusion Criteria p9.1.1.1 Inclusion Criteria [answer] p9.1.1.2 Exclusion Criteria [answer] p9.1.2 Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination) [answer] 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 [answer] p9.1.4 Can study participants participate in another research study while participating in this research study expandedYes-NoIndicator Y: Yes p9.1.5 Screen Failures [answer] p9.1.6 Lifestyle Considerations [answer] p9.1.7 Vulnerable Populations p9.1.7.1 Can or will pregnant women be enrolled expandedYes-NoIndicator N: No p9.1.7.3 Can or will the research involve neonates of uncertain viability or non-viable neonates? expandedYes-NoIndicator N: No p9.1.7.4 Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled? expandedYes-NoIndicator N: No 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? expandedYes-NoIndicator Y: Yes 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. 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 [answer] 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 [answer] p9.1.7.7.3 Describe any additional steps or procedures that will be used when performing informed consent with this population [answer] 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? expandedYes-NoIndicator N: No p9.1.7.10 Can or will prisoners be enrolled? expandedYes-NoIndicator N: No p9.1.7.12 Can or will students and/or employees be enrolled in this research? expandedYes-NoIndicator Y: Yes p9.1.7.13 Enrollment of students and/or employees p9.1.7.13.1 Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees [answer] p9.1.7.13.2 Describe how potential coercion will be eliminated [answer] 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 [answer] p9.1.7.13.4 Describe additional safeguards included to protect the rights and welfare of students and employees [answer] 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 [answer] 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. expandedYes-NoIndicator Y: Yes 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)? expandedYes-NoIndicator N: No p9.2 Strategies for Recruitment and Retention p9.2.1 Recruitment Methods p9.2.1.1 Describe when, where, and how potential participants will be recruited [answer] 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.). [answer] p9.2.1.3 Describe source of participants (for example, patient population, local community, etc.) [answer] p9.2.1.4 Describe methods that will be used to identify potential participants [answer] p9.2.1.5 Describe how the recruitment methods described will be effective in attracting the targeted participant population [answer] p9.3 Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.) [answer] p10 Study Intervention p10.1 Study Agent p10.1.1 Study Agent and Control Description [answer] p10.1.2 Receipts/Acquisition [answer] p10.1.3 Study Agent Accountability/ Return or Destruction of Investigational Product [answer] p10.1.4 Formulation and appearance of Control Product [answer] p10.1.5 Formulation and appearance of Test Product [answer] p10.1.6 Packaging and Labeling [answer] p10.1.7 Product Storage and Stability [answer] p10.1.8 Preparation [answer] p10.1.9 Administration and/or Dosing [answer] p10.1.10 Route of Administration [answer] p10.1.11 Starting Dose and Dose Escalation Schedule [answer] p10.1.12 Dose Adjustments/Modifications/Delays [answer] p10.1.13 Duration of Therapy [answer] p10.1.14 Tracking Dose [answer] p10.1.15 Device Specific Considerations [answer] p10.1.16 Administration Instructions [answer] p10.1.17 Dispensing [authority, requirements] [answer] p10.1.18 Supply of Study Drug at the Site [answer] p10.3 Study Procedural Intervention(s) Description p10.3.1 Administration of Procedural Intervention [answer] p10.3.2 Procedures for Training of Clinicians on Procedural Intervention [answer] p10.3.3 Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention [answer] p10.4 Participant Compliance and Monitoring [answer] p10.5 Study Intervention/Experimental Manipulation Adherence [answer] p11 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal p11.1 Discontinuation of Study Intervention [answer] p11.2 Participant withdrawal and Termination p11.2.1 Reasons for Withdrawal or Termination [answer] p11.2.2 Handling of Participant Withdrawal or Termination [answer] p11.2.3 Replacement of participants [answer] p11.3 Lost to Follow-Up [answer] p12 Study Procedures p12.1 Study Procedures/Evaluations p12.1.1 Study Specific Procedures [answer] p12.1.2 Standard of Care Study Procedures [answer] p12.2 Laboratory Procedures/Evaluations p12.2.1 Clinical Laboratory Evaluations [answer] p12.2.2 Research Laboratory Evaluations [answer] p12.2.3 Other Assays or Procedures [answer] p12.2.4 Specimen Preparation, Handling, and Storage [answer] p12.2.5 Specimen Shipment [answer] p12.3 Data Collection and Follow Up for Withdrawn participants [answer] p12.4 Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception). [answer] p12.5 Precautionary Medications, Treatments, and Procedures [answer] p12.6 Prohibited Medications, Treatments, and Procedures [answer] p12.7 Prophylactic Medications, Treatments, and Procedures [answer] p12.8 Rescue Medications, Treatments, and Procedures [answer] p12.9 Participant Access to Study Agent at Study Closure [answer] p12.10 Concomitant Medications, Treatments , and Procedures [answer] p13 Schedule of Study Procedures p13.1 Screening [answer] p13.2 Enrollment/Visit 1/Baseline Visit [answer] p13.3 Intermediate Visits [answer] p13.4 Final Study Visit [answer] p13.5 Withdrawal/Early Termination Visit [answer] p13.6 Unscheduled Visit [answer] p13.7 Follow Up Phase of the Study p13.7.1 Visit [answer] p13.7.2 End of Study Visit [answer] p13.15 Schedule of Study Procedures Attachments p13.15.2 Attachment No display for Attachment p14 Assessment of Safety p14.1 Specification of Safety Parameters p14.1.1 Definition of Adverse Events(AE) [answer] p14.1.2 Definition of Serious Adverse Events (SAE) [answer] p14.1.3 Definition of Unanticipated Problems [answer] p14.2 Classification of an Adverse Event p14.2.1 Severity of an Event [answer] p14.2.2 Relationship to Study Intervention/Experimental Manipulation [answer] p14.2.3 Expectedness [answer] p14.3 Time Period and Frequencey for Event Assessment and Follow-Up [answer] p14.4 Reporting Procedures p14.4.1 Notifying the IRB p14.4.1.1 Adverse Event Reporting [answer] p14.4.1.2 Serious Adverse Event Reporting [answer] p14.4.1.3 Unanticipated Problem Reporting [answer] p14.4.1.4 Reporting of Pregnancy [answer] p14.4.2 Notifyiing the Study Sponsor [answer] p14.4.3 Notifying the FDA [answer] p14.4.4 Notifying Participating Investigators [answer] p14.4.5 Reporting Events to Participants [answer] p14.4.6 Events of Special Interest [answer] p14.5 Follow Up Report [answer] p14.6 Study Halting/Stopping Rules [answer] p15 Statistical Considerations p15.1 Statistical and Analytical Plans(SAP) [answer] p15.2 Statistical Hypotheses [answer] p15.3 Analysis Datasets [answer] p15.4 Populations for Analysis [answer] p15.5 Sample Size Determination [answer] p15.6 Description of Statistical Methods p15.6.1 General Approach [answer] p15.6.2 Analysis of Primary Efficacy Endpoints(s) [answer] p15.6.3 Analysis of Secondary Endpoint(s) [answer] p15.6.4 Safety Analyses [answer] p15.6.5 Adherence and Retention Analyses [answer] p15.6.6 Baseline Descriptive Statistics [answer] p15.6.7 Planned Interim Analyses p15.6.7.1 Safety Review [answer] p15.6.7.2 Efficacy Review [answer] p15.6.8 Additional Sub-Group Analyses [answer] p15.6.9 Multiple Comparison/Multiplicity [answer] p15.6.10 Tabulation of Individual Response Data [answer] p15.6.11 Exploratory Analyses [answer] p15.6.12 Pharmacokinetic Analysis (if applicable) [answer] p15.7 Sample Size 100 p15.8 Measures to Minimize Bias p15.8.1 Enrollment/Randomization/Masking Procedures [answer] p15.8.2 Evaluation of Success of Blinding [answer] p15.8.3 Breaking the Study Blind/Participant Code [answer] p16 Supporting Documentation and Operational Considerations p16.1 Regulatory, Ethical and Study Oversight Considerations p16.1.1 Protocol Amendments [answer] p16.1.2 Ethical Standard [answer] p16.1.3 Institutional Review Board [answer] p16.1.4 Informed Consent Process p16.1.4.1 Consent/Assent and Other Informational Documents Provided to Participants [answer] p16.1.4.2 Consent Procedures and Documentation 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 [answer] p16.1.4.2.2 Describe the parental permission process and the child assent process. (If study involves children) [answer] 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 [answer] p16.1.4.2.4 Methods of Informed Consent for non-English Speakers [answer] p16.1.4.2.5 Waiver or Alteration of Consent Process [answer] p16.1.4.2.6 HIPAA Authorization p16.1.4.2.6.1 Participant's Capacity to Give Legally Effective Consent [answer] p16.1.4.3 Indicate where the consent process will take place. [answer] p16.1.5 Participant data and Confidentialty p16.1.5.1 Research Use of Stored Human Samples, Specimens, or Data [answer] p16.1.5.2 Confidentiality of Research Biospeciemen/Data [answer] p16.1.5.3 Certificate of Confidentiality (if applicable) [answer] p16.1.5.4 Provisions to Protect the Privacy of Participants [answer] p16.1.6 Future Use of Stored Human Specimens and Data [answer] p16.1.7 Study Discontinuation and Closure [answer] p16.1.8 Key Roles and Expertise of Study Team p16.1.8.1 First Name [answer] p16.1.8.2 Last Name [answer] p16.1.8.3 Position/Title [answer] p16.1.8.4 Responsibilities [answer] p16.1.8 Key Roles and Expertise of Study Team p16.1.8.1 First Name [answer] p16.1.8.2 Last Name [answer] p16.1.8.3 Position/Title [answer] p16.1.8.4 Responsibilities [answer] p16.1.8 Key Roles and Expertise of Study Team p16.1.8.1 First Name [answer] p16.1.8.2 Last Name [answer] p16.1.8.3 Position/Title [answer] p16.1.8.4 Responsibilities [answer] p16.1.8 Key Roles and Expertise of Study Team p16.1.8.1 First Name [answer] p16.1.8.2 Last Name [answer] p16.1.8.3 Position/Title [answer] p16.1.8.4 Responsibilities [answer] p16.1.9 Safety Oversight [answer] p16.1.10 Clinical Monitoring [answer] p16.1.11 Quality Assurance and Quality Control [answer] p16.1.12 Data Handling and Record Keeping p16.1.12.1 Data Quality Control and Reporting [answer] p16.1.12.2 Data Collection and Management Responsibilities [answer] p16.1.12.3 Data Archival [answer] p16.1.12.4 Study Records Retention p16.1.12.4.1 Photographs, Audio/Video Recordings Retention [answer] p16.1.12.4.2 Data and/or Biological Specimens Access [answer] p16.1.12.4.3 Data and/or Biological Specimens Retention/Banking [answer] p16.1.13 Protocol Deviations [answer] p16.1.14 Publication and Data Sharing Policy [answer] p16.1.15 Conflict of Interest Policy [answer] p16.1.16 Source Documents and Access to Source Data/Documents [answer] p16.1.17 Collections of Photographs, or Audio/Video Recording [answer] p16.2 Prior Approvals/Attachments Requiring Signatures p16.2.1 Prior Approvals/Attachments Requiring Signatures [answer] p16.2.2 Attachment No display for Attachment p16.3 Additional Considerations [answer] p16.4 Abbreviations and Special Terms [answer] p16.5 Other Supporting Documentation and Operational Considerations Attachments p16.5.1 Describe the file that is being attached (optional) [answer] p16.5.2 Attachment No display for Attachment p17 Study Administration p17.1 Setting p17.1.1 Describe the sites / locations where your research team will conduct the research [answer] p17.2 Registration 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.) [answer] p17.3 Resources Available p17.3.1 Describe the roles/tasks of each research team member [answer] 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 [answer] 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 [answer] 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 [answer] p17.3.5 Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study? expandedYes-NoIndicator Y: Yes p17.4 IRB Review p17.4.1 An appropriate IRB , registered with the OHRP ,review and approve this study. expandedYes-NoIndicator Y: Yes 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? expandedYes-NoIndicator Y: Yes p17.5 Community-Based Participatory Research/Field Research p17.5.1 Can or will this study involve community-based participatory research? expandedYes-NoIndicator Y: Yes p17.5.2 Community-based participatory research p17.5.2.1 Describe the communities that will be involved in this research [answer] p17.5.2.2 Describe the composition and involvement of any community advisory board [answer] 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 [answer] p17.5.2.4 Describe the plans on dissemination and publication of study results which are in agreement with the community [answer] p17.6 Multi Site Research p17.6.1 Describe the plan for tracking IRB approval of documents and consent forms for each site [answer] p17.6.2 Name of the sponsor(s) and Contract Research Organization (CRO) ExternalDataFor_p17.6.2.1 External Data For linkId p17.6.2.1 p17.6.2.1 Name of the sponsor(s) p17.6.2.2 Name of the Contract Research Organization (CRO) Sample CRO, Inc. 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 [answer] 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 [answer] p17.6.5 Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms [answer] 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 [answer] p17.6.7 Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations 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.) [answer] p17.6.7.2 Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail? [answer] 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) [answer] p17.6.9 Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable) p17.6.9.1 Describe how they will be provided to each enrolling site [answer] p17.6.9.2 Describe how dispensing will be monitored [answer] p17.6.9.3 Describe what investigational product accountability procedures will be implemented [answer] p17.6.10 Describe the procedures for study closures and early site termination [answer] 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) [answer] p17.7 Key Roles and Study Governance [answer] p18 Study Finances p18.1 Funding Source [answer] p18.2 Costs to the participant [answer] p18.3 Participant Reimbursements or Payments [answer] p18.4 Compensation for Research-Related Injury [answer] p19 References p19.1 List any references here, unless already cited. [answer] p19.2 Reference list attachment (optional) p19.2.2 Attachment No display for Attachment p25 Other Attachments to the Protocol p25.1 Other Attachment(s) to the Protocol p25.1.1 Describe the file that is being attached [answer] p25.1.2 Attachment No display for Attachment p25.1 Other Attachment(s) to the Protocol p25.1.1 Describe the file that is being attached [answer] p25.1.2 Attachment No display for Attachment ADMIN00 Administrative Use Only ADMIN01 Link ID prefix p ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any initiate-study-populate-exampleQR ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any ResearchStudyExample-sIRB Documentation for this format
Does this protocol require a FDA exemption?
Is an IND or IDE being used in this study?
A clinical study of the efficacy of Drug A for arthritis
Organization of Arthritis Patients Foundation
A ClinicalStudy of Drug A for arthritis12345
Funding Organization(s), Address and Contact Information
Sponsor(s), Address and Contact Information
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.]
Accrual Ceiling/Number of Participants (projected-for all sites)
Description of Sites/Facilities Enrolling Participants
Description of Study Intervention ( Agent/Procedure)/Investigational Product
Duration of Investigational Product Administration
Describe the file that is being attached (optional)
Introduction, Background Information and Scientific Rational
Describe the relevant literature and the specific gaps in current knowledge that this study intends to address
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
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.
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?
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
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
Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.
Describe the file that is being attached
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)
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
Can or will the research involve neonates of uncertain viability or non-viable neonates?
Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?
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?
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)?
Strategies for Recruitment and Retention
Describe when, where, and how potential participants will be recruited
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.)
Study Agent Accountability/ Return or Destruction of Investigational Product
Formulation and appearance of Control Product
Formulation and appearance of Test Product
Starting Dose and Dose Escalation Schedule
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
Study Intervention/Experimental Manipulation Adherence
Study Intervention Discontinuation and Participant Discontinuation/Withdrawal
Handling of Participant Withdrawal or Termination
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
Participant Access to Study Agent at Study Closure
Concomitant Medications, Treatments , and Procedures
Schedule of Study Procedures Attachments
Definition of Serious Adverse Events (SAE)
Relationship to Study Intervention/Experimental Manipulation
Time Period and Frequencey for Event Assessment and Follow-Up
Analysis of Primary Efficacy Endpoints(s)
Pharmacokinetic Analysis (if applicable)
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
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
Other Supporting Documentation and Operational Considerations Attachments
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)
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.
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any