Structure LinkId Text Cardinality Type Flags Description & Constraints Consent_Questionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire-populate#1.0.0 c1 Research Study 0..1 group c1.1 Study Title 0..1 text Expressions: Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value c1.1_help Short Title of the Research Study 0..1 display c1.2 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value c38 Study Site 0..1 group ExternalDataFor_c38.1 External Data For linkId c38.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value c38.1 Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below. 0..1 choice c38.1_help This question and its answer will not print on the Consent Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details. 0..1 display c38.2 Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI? 1..1 choice Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding c38.2_help This question and its answer will not print on the Consent Form but are necessary for the form logic. 0..1 display c40 Study Site Principal Investigator and Study Site 0..1 group c40.1 Multi-site statement 0..1 text Initial Value: string = This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed. c40.2 Statement for Consent Form at Lead PI Site 0..1 text Enable When: c38.2 = Yes (expandedYes-NoIndicator#Y) Initial Value: string = In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study. c40.3 Statement for Consent Form at Relying Site (not Lead PI Site) 0..1 text Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) Initial Value: string = This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site. c40.5 Principal Investigator at Study Site 0..1 group c40.5.2 First Name 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value c40.5.2_help First or given name of the relying site PI 0..1 display c40.5.1 Last Name 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value c40.5.1_help Surname or family name of the relying site PI 0..1 display c40.5.6 Suffix 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value c40.5.6_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display c40.5.3 Degree(s) 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value c40.5.3_help Professional and Academic degrees of the relying site PI 0..1 display c40.5.4 Associated Institution 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value c40.5.4_help Relying site PI's Academic or Professional Institution 0..1 display c40.5.8 Contact Information 0..1 group c40.5.8.20 Phone 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value c40.5.8.20_help 10-digit phone number, including area code 0..1 display c40.5.8.21 Email 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value c40.5.8_help Information on how to contact the Site PI. 0..1 display c40.5_help Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site 0..1 display c40.9 Study Site Institution 0..1 group c40.9.1 Institution Name 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value c40.9.1_help Public or private entity conducting the study- where the participant will go or call 0..1 display c40.9.2 Address 0..1 group c40.9.2.10 Street Address 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value c40.9.2.11 City 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value c40.9.2.12 State 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value c40.9.2.13 Zip Code 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value c40.9.2.14 Country 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value c40.9_help Information about institution for the site where study will be conducted 0..1 display c49 Lead Principal Investigator and Lead Principal Investigator Site 0..1 group Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) c49.1 Statement about Lead PI and Lead PI Site for Consent Form at Relying Site 0..1 text Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) Initial Value: string = In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information. c49.2 Lead Principal Investigator 0..1 group c49.2.2 First Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value c49.2.2_help First or given name of the lead PI 0..1 display c49.2.1 Last Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value c49.2.1_help Surname or family name of the lead PI 0..1 display c49.2.6 Suffix 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value c49.2.6_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display c49.2.3 Degree(s) 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value c49.2.3_help Professional and Academic degrees of the lead PI 0..1 display c49.2.5 Contact Information 0..1 group c49.2.5.20 Phone 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value c49.2.5.20_help 10-digit phone number, including area code 0..1 display c49.2.5.21 Email 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value c49.2.5_help Information on how to contact the Lead PI. 0..1 display c49.2_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 c49.5 Lead Principal Investigator Institution 0..1 group Enable When: c38.2 != Yes (expandedYes-NoIndicator#Y) c49.5.1 Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value c49.5.1_help Public or private entity associated with the lead principal investigator conducting the overall study. 0..1 display c49.5.2 Address 0..1 group c49.5.2.10 Street Address 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value c49.5.2.11 City 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value c49.5.2.12 State 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value c49.5.2.13 Zip Code 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value c49.5.2.14 Country 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value c49.5_help Information about Lead Institution 0..1 display c4 Sponsor or Funding Source 0..1 group ExternalDataFor_c4.1 External Data For linkId c4.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.item.where(repeat(item).where(linkId = 'in5.1' and answer.value.code = 'SFS')).repeat(item).where(linkId = 'in5.2').answer.value c4.1 Sponsor Name 0..* open-choice c4.1_help Entity financially supporting the research 0..1 display c5 Sponsor Detail 0..1 text c5_help Any additional relevant information about the sponsor(s) 0..1 display c6 Is this consent an eConsent? 0..1 choice Options: 2 options c6_help Consent that is obtained electronically 0..1 display c7 Summary Text 0..1 group c7.1 Summary Text Statement 1..1 text c7.1_help Describes the basic purpose, procedures and reasons behind the research in easily understood prose 0..1 display c7_help Section header for the mandated text describing the basic purpose, procedures and reasons for the study. 0..1 display c8 Introduction and Statement of Research 0..1 group c8.1 About Consent Form 0..1 text Initial Value: string = This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate. c8_help Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process. 0..1 display c9 Purpose 0..1 group c9.1 Reason for Research 0..1 text c9.1_help Explanation about why the study is being conducted 0..1 display c9.2 Interactions with others 0..1 text c9.2_help Statement of whom the participant can anticipate interacting with during study participation 0..1 display c9.3 Invited Participants 0..1 text c9.3_help High level information about what participating in the study will entail for the participant 0..1 display c9.4 Total expected study enrollment 0..1 integer c9.4_help The total number of people targeted for enrollment in the multi-site study 0..1 display c9.5 Additional Enrollment Text 0..1 text c9.5_help Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site 0..1 display c9.6 What is involved in the study? 0..1 text c9.6_help High level information about what participating in the study will entail for the participant. 0..1 display c10 Assessments 0..1 group c10.1 Assessment List 0..* group c10.1.1 Name of the Assessment 0..1 string c10.1.1_help Short name of the assessment 0..1 display c10.1.2 Description of Assessment 0..1 text c10.1.2_help Short description of the assessment 0..1 display c10.31 null 0..1 display c10.2 Assessment Supplemental Text 0..1 text c10.2_help Additional text to provide additional context about the assessments collected 0..1 display c10.32 null 0..1 display c10.3 Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire? 0..1 choice Options: 2 options c10.3_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Assessment List" table in the questionnaire. 0..1 display c10.4 Assessment List Attachment(s) 0..* group Enable When: c10.3 = Yes (expandedYes-NoIndicator#Y) c10.4.1 Describe the file that is being attached (optional) 0..1 string c10.4.2 Upload attachment(s) here. 0..1 attachment c10.33 null 0..1 display c11 Visits and Procedures 0..1 group c11.1 Visit Introductory Text 0..1 text c11.1_help Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule. 0..1 display c11.2 Visit List 0..* group c11.2.1 Visit Type 0..1 string c11.2.1_help Unique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final 0..1 display c11.2.2 Visit Description 0..1 text c11.2.2_help Description of Visit types, including what procedures it contains 0..1 display c11.2.3 Visit Duration 0..1 decimal c11.2.4 Visit Duration Units 0..1 choice Options: 3 options c11.2.4_help Choices for visit duration units are minutes (min), hours (h) or days (d). 0..1 display c11.2.5 Number of Visits 0..1 integer c11.31 null 0..1 display c11.6 Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire? 0..1 choice Options: 2 options c11.6_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Visit List" table in the questionnaire. 0..1 display c11.7 Visit List Attachment(s) 0..* group Enable When: c11.6 = Yes (expandedYes-NoIndicator#Y) c11.7.1 Describe the file that is being attached (optional) 0..1 string c11.7.2 Upload attachment(s) here. 0..1 attachment c11.32 null 0..1 display c11.3 Procedure List 0..* group c11.3.1 Name of Procedure 0..1 string c11.3.2 Common Term of Procedure 0..1 string c11.3.3 Description of a Procedure 0..1 text c11.3.4 Experimental Procedure Indicator 0..1 choice Options: 2 options c11.3.5 Research Indicator 0..1 choice Options: 2 options c11.3.6 Frequency 0..1 string c11.3.6_help Specify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week. 0..1 display c11.3.9 Procedure Duration (minutes) 0..1 integer c11.3.9_help Specify the procedure duration in minutes 0..1 display c11.33 null 0..1 display c11.4 Procedure Supplemental Text 0..1 text c11.4_help Additional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule 0..1 display c11.34 null 0..1 display c11.9 Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire? 0..1 choice Options: 2 options c11.9_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire. 0..1 display c11.10 Procedure List Attachment(s) 0..* group Enable When: c11.9 = Yes (expandedYes-NoIndicator#Y) c11.10.1 Describe the file that is being attached (optional) 0..1 string c11.10.2 Upload attachment(s) here. 0..1 attachment c11.35 null 0..1 display c11.5 Total Duration of Study Participation 0..1 string c11.5_help Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion 0..1 display c12 Risks 0..1 group c12.1 Risk List 0..* group c12.1.1 Name of the risk 0..1 string c12.1.2 Description of Risk 0..1 text c12.1.3 Risk Category 0..1 choice Options: 2 options c12.33 null 0..1 display c12.9 Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire? 0..1 choice Options: 2 options c12.9_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Risk List" table in the questionnaire. 0..1 display c12.10 Risk List Attachment(s) 0..* group Enable When: c12.9 = Yes (expandedYes-NoIndicator#Y) c12.10.1 Describe the file that is being attached (optional) 0..1 string c12.10.2 Upload attachment(s) here. 0..1 attachment c12.37 null 0..1 display c12.2 Risk Supplemental Text 0..1 text c12.2_help Additional text for description of other risks 0..1 display c12.3 Fetal Risks 0..1 choice Options: 2 options c12.3_help Indicates whether risks to the fetus are possible 0..1 display c12.4 Fetal Risk Details 0..1 text Enable When: c12.3 = Yes (expandedYes-NoIndicator#Y) c12.4_help Textual description of risks to the fetus 0..1 display c13 Alternative Procedures 0..1 group c13.1 Alternative Procedure Text 0..1 text c13.1_help Describe any other treatment/procedure that may be used other than those described for study participation. 0..1 display c14 Benefits 0..1 group c14.1 Benefits List 0..* group c14.1.1 Name of Benefit 0..1 string c14.1.2 Description of Benefit 0..1 text c14.1.3 Benefit to you 0..1 choice Options: 2 options c14.1.4 Benefit to society 0..1 choice Options: 2 options c14.31 null 0..1 display c14.9 Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire? 0..1 choice Options: 2 options c14.9_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire. 0..1 display c14.10 Benefits List Attachment(s) 0..* group Enable When: c14.9 = Yes (expandedYes-NoIndicator#Y) c14.10.1 Describe the file that is being attached (optional) 0..1 string c14.10.2 Upload attachment(s) here. 0..1 attachment c14.33 null 0..1 display c15 Compensation 0..1 group c15.1 Will there be compensation for participation? 0..1 choice Options: 2 options c15.1_help Indicates whether compensation will be offered or not for the study 0..1 display c15.2 Compensation Supplemental Text 0..1 text Enable When: c15.1 = Yes (expandedYes-NoIndicator#Y) c15.2_help Additional text about compensation not captured in the compensation table 0..1 display c15.3 Compensation List 0..* group Enable When: c15.1 = Yes (expandedYes-NoIndicator#Y) c15.3.1 What types of visits or milestones will I be compensated for? 0..1 text c15.3.2 How many visits or milestones of this type will there be compensation for? 0..1 integer c15.3.3 How much will be paid per that type of visit? 0..1 text c15.33 null 0..1 display c15.5 Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire? 0..1 choice Options: 2 options c15.5_help If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Compensation List" table in the questionnaire. 0..1 display c15.7 Compensation List Attachment(s) 0..* group Enable When: c15.5 = Yes (expandedYes-NoIndicator#Y) c15.7.1 Describe the file that is being attached (optional) 0..1 string c15.7.2 Upload attachment(s) here. 0..1 attachment c15.35 null 0..1 display c16 Costs 0..1 group c16.1 What are the costs of participation, if any? 0..1 text c16.1_help Explanation informing participant if any additional costs will occur to the participant as a result of taking part in the study 0..1 display c16.2 Will there be reimbursement for other study visit costs incurred? 0..1 choice Options: 2 options c16.2_help Reimbursement to participant for other study visit costs not directly associated with a visit 0..1 display c16.3 Will costs be covered for medical treatment if research related injury occurs? 0..1 choice Options: 3 options c16.3_help Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury 0..1 display c16.4 Additional description of treatment coverage 0..1 text c16.4_help Description of other costs not directly associated with a visit 0..1 display c17 Participant Rights and whom to contact for answers 0..1 group c17.1 What are the rights of a participant? 0..1 text c17.1_help Statement of particpant rights 0..1 display c17.2 Site IRB Contact Information 0..1 group c17.2.1 IRB Contact Name 0..1 string c17.2.8 IRB Name 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value c17.2.9 Department Name or Division 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.10').answer.value c17.2.10 Street Address 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.3').answer.value c17.2.11 City 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.4').answer.value c17.2.12 State 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.5').answer.value c17.2.13 Zip Code 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.6').answer.value c17.2.14 Country 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.7').answer.value c17.2.20 Phone 0..1 string c17.2.20_help 10-digit phone number, including area code 0..1 display c17.2.21 Email 0..1 string c17.2_help Contact information for the site IRB contact. 0..1 display c17.3 Study Coordinator Contact Information 0..1 group c17.3.1 Study Coordinator Name 0..1 string c17.3.8 Study Coordinator Institution or Organization 0..1 string c17.3.9 Department Name or Division 0..1 string c17.3.10 Street Address 0..1 string c17.3.11 City 0..1 string c17.3.12 State 0..1 string c17.3.13 Zip Code 0..1 string c17.3.14 Country 0..1 string c17.3.20 Phone 0..1 string c17.3.20_help 10-digit phone number, including area code 0..1 display c17.3.21 Email 0..1 string c17.3_help Contact information for the study coordinator 0..1 display c17.4 Site Principal Investigator Contact Information 0..1 group c17.4.1 Site Principal Investigator Name 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.where(linkId = 'in8.10').answer.value c17.4.8 Site Principal Investigator Institution 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value c17.4.9 Department Name or Division 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value c17.4.10 Street Address 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value c17.4.11 City 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value c17.4.12 State 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value c17.4.13 Zip Code 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value c17.4.14 Country 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value c17.4.20 Phone 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value c17.4.20_help 10-digit phone number, including area code 0..1 display c17.4.21 Email 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value c17.4_help Contact information for the PI. May be replicated from above. 0..1 display c18 Participation 0..1 group c18.1 Voluntary Permission Statement 0..1 text Initial Value: string = Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled. c18.1_help Standard prepopulated statement, can be edited. 0..1 display c18.2 What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent. 0..1 text c18.2_help Anticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent 0..1 display c19 Early Withdrawal 0..1 group c19.1 Are there consequences to participant for early withdrawal? 0..1 choice Options: 2 options c19.2 Are there Emotional Consequences of Withdrawal 0..1 choice Enable When: c19.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c19.3 Are there Physical Consequences of Withdrawal 0..1 choice Enable When: c19.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c19.4 What are the consequences of withdrawal? 0..1 text Enable When: c19.1 = Yes (expandedYes-NoIndicator#Y) c19.4_help Description of the withdrawal consequences, will depend and vary based on type of study. 0..1 display c20 Confidentiality of Records 0..1 group c20.1 Will HIPAA content be included within this document? 0..1 choice Options: 2 options c20.2 Medical information and billing statement 0..1 text Enable When: c20.1 = Yes (expandedYes-NoIndicator#Y) Initial Value: string = Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care. c20.2_help If template information required for your state differs from text provided, reword to satisfy state requirements. 0..1 display c20.3 Will confidentiality be protected? 0..1 choice Options: 2 options c20.3_help Indicates if records identifying a subject will be maintained. 0..1 display c20.4 How will confidentiality be protected? 0..1 text Enable When: c20.3 = Yes (expandedYes-NoIndicator#Y) c20.4_help Explanation about processes and procedures to support maintaining privacy and confidentiality 0..1 display c20.5 Are there data security or policies that need to be included in the consent, particularly around device use (optional) 0..1 choice Options: 2 options c20.5_help Indicates if any data security policy applies to this consent, including device use. 0..1 display c20.6 Describe any data security policies and processes protecting the data 0..1 text Enable When: c20.5 = Yes (expandedYes-NoIndicator#Y) c20.6_help Optional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection 0..1 display c20.7 Who can use or see participant information? 0..* group c20.7.1 Role or group who will have access to data 0..1 open-choice Options: 3 options c20.7.2 Description of Information Disclosed 0..1 text c20.8 Will the data be released for future use? 0..1 choice Options: 2 options c20.8_help Indicates whether these data will be used beyond the study window 0..1 display c20.9 Will the future use data be deidentified? 0..1 choice Enable When: c20.8 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c20.9_help Indicates if shared data will retain any identifiers. 0..1 display c20.10 Deidentification detail 0..1 text Enable When: c20.9 = Yes (expandedYes-NoIndicator#Y) c20.10_help Description of deidentification details for future use datasets. 0..1 display c20.11 Required text disclosure surrounding future use. 0..1 choice Enable When: c20.8 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c20.11_help Select the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements. 0..1 display c21 Specimen Management 0..1 group c21.1 Were specimens collected as part of this study? 0..1 choice Options: 2 options c21.2 Is whole genome sequencing being conducted? 0..1 choice Enable When: c21.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c21.2_help Indicator of if genome sequencing is being conducted in conjunction with study 0..1 display c21.3 Sharing or no Sharing of samples. 0..1 choice Enable When: c21.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c21.3_help Indicator of whether biospecimens will be shared outside of the immediate study team or institution. 0..1 display c21.4 Conditions of sharing 0..1 text Enable When: c21.3 = Yes (expandedYes-NoIndicator#Y) c21.4_help Textual description of sharing conditions including, type, when, etc. 0..1 display c21.5 Will participant share in profit with commerical use? 0..1 choice Enable When: c21.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c21.5_help Indicator of any plans to profit share any funds received as a result of commercial use of those samples. 0..1 display c21.6 Description of Collection and Storage 0..1 text Enable When: c21.1 = Yes (expandedYes-NoIndicator#Y) c21.6_help Textual description of collection and storage procedures and policies for the study. 0..1 display c21.7 Can consent for sample use be revoked? 0..1 choice Enable When: c21.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options c21.7_help Indicator of revocation of sample consent is an option 0..1 display c22 Will there be Broad Consent for Storage, maintenance and secondary research use? 0..1 choice Options: 2 options c22.1 Statement of Broad Consent for Storage, maintenance and secondary research use 0..1 text Enable When: c22 = Yes (expandedYes-NoIndicator#Y) Initial Value: string = Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose. c23 Can the study team contact you for future research? 0..1 choice Options: 2 options c23.1 Conditions about contact for additional sample use, information not currently described or future research 0..1 text Enable When: c23 = Yes (expandedYes-NoIndicator#Y) c23.1_help Description of the details for which the participant could be contacted 0..1 display c23_help Indicator if the participant contact information can be used for future questions or recuitment for this or other studies 0..1 display c24 Will participants share in commercial profit? 0..1 choice Options: 2 options c24.1 Details about any profit sharing agreements or why profits will not be shared. 0..1 text Enable When: c24 = Yes (expandedYes-NoIndicator#Y) c24_help Indicator of participants will receive any commercial profits resulting from their participation in study 0..1 display c25 Will the study team contact you with new information that may affect your willingness to remain in the study 0..1 choice Options: 2 options c25_help Indicator if study team will provide updates that may affect willingness to remain in study 0..1 display c26 Will the study team disclose clinically relevant study results to you? 0..1 choice Options: 2 options c26.1 Condtions under which the study results will be disclosed to you 0..1 text Enable When: c26 = Yes (expandedYes-NoIndicator#Y) c26.1_help Textual description of which results and when will be disclosed to you. 0..1 display c26_help Indicator of study team will provide results of lab tests or other feedback of results to you at any time. 0..1 display c27 Clinical Trials.gov statement 0..1 text Initial Value: string = A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. c28 Is this study covered under a Certificate of Confidentiality? (default Y in NIH) 0..1 choice Options: 2 options c28.1 Certificate of Confidentiality Statement 0..1 text Enable When: c28 = Yes (expandedYes-NoIndicator#Y) Initial Value: string = The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc] c28.1_help Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies) 0..1 display c28.2 Required Disclosures based on state law 0..1 text Enable When: c28 = Yes (expandedYes-NoIndicator#Y) c28.2_help Add any required text per your state laws. 0..1 display c29 When will the PHI Authorization Expire based on date or time past an event 0..1 text c29_help PHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure. 0..1 display c30 Statement of PHI Authorization Revocation 0..1 text Initial Value: string = Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared. c31 Signature 0..1 group c31.1 Indicator to include Participant Signature and Date/Time 0..1 choice Options: 2 options c31.2 Indicator to include Assent Signature and Date/Time 0..1 choice Options: 2 options c31.3 Indicator to include Legally Authorized Representative Signature and Date/Time 0..1 choice Options: 2 options c31.4 Relationship of Legally Authorized Representative 0..1 choice Options: 6 options c31.5 Indicator to include a Witness Signature and Date/Time 0..1 choice Options: 2 options c31.6 Indicator to include Parent 1 Signature and Date/Time 0..1 choice Options: 2 options c31.7 Indicator to include Parent 2 Signature and Date/Time 0..1 choice Options: 2 options c32 Consent Version 0..1 group c32.1 Consent Version Number 0..1 string c32.2 sIRB Version Date of Consent 0..1 date c32.2_help Date that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy. 0..1 display c32.3 Relying Site Version Date of Consent 0..1 date c32.3_help A number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy. 0..1 display c32.6 Expiration Date of Consent 0..1 dateTime c80 Other Attachments 0..* group c80.1 Describe the file that is being attached (optional) 0..1 string c80.2 Attachment 0..1 attachment c80_help Other attachments that will be included in the Consent Form that will be provided to the participants should be included here. 0..1 display ADMIN00 Administrative Use Only 0..1 group ADMIN01 Link ID prefix 0..1 string Initial Value: string = c 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 c38.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c10.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c11.2.4 http://unitsofmeasure.org#min ("min") http://unitsofmeasure.org#h ("h") http://unitsofmeasure.org#d ("d") Answer options for c11.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c11.3.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c11.3.5 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RES ("Research") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#STDCR ("Standard of Care") Answer options for c11.9 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c12.1.3 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PHYS ("Physical") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NONPHYS ("Non-Physical") Answer options for c12.9 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c12.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c14.1.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c14.1.4 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c14.9 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c15.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c15.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c16.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c16.3 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#TRTNOTCOV ("Treatment not covered") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RRICOV ("Research Related injury covered") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ACNOTCICOV ("Acute but not chronic injury covered") Answer options for c19.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c19.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c19.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.7.1 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OTHINSTRES ("Researchers at other institutions") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#THISINSTRES ("Researchers outside the study team at this institution") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#EXTREGAUTH ("External Regulatory Authorities") Answer options for c20.8 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.9 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c20.11 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEIDUSED ("Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEIDNOTUSED ("Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.") Answer options for c21.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c21.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c21.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c21.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c21.7 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c22 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c23 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c24 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c25 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c26 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c28 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.1 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.2 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.3 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.4 http://terminology.hl7.org/CodeSystem/v2-0063#PAR ("Parent") http://terminology.hl7.org/CodeSystem/v2-0063#SPO ("Spouse") http://terminology.hl7.org/CodeSystem/v2-0063#CHD ("Child") http://terminology.hl7.org/CodeSystem/v2-0063#SIB ("Sibling") http://terminology.hl7.org/CodeSystem/v2-0063#GRD ("Guardian") http://terminology.hl7.org/CodeSystem/v2-0063#OTH ("Other") Answer options for c31.5 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.6 http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes") http://terminology.hl7.org/CodeSystem/v2-0532#N ("No") Answer options for c31.7 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.descendants().where(linkId = 'c38.1').answer.valueCoding.display
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value
%lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value
%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').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).
%resource.repeat(item).where(linkId = 'ExternalDataFor_c38.1').answer.value
Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.
This question and its answer will not print on the Consent Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding
Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?
This question and its answer will not print on the Consent Form but are necessary for the form logic.
Study Site Principal Investigator and Study Site
This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed.
Statement for Consent Form at Lead PI Site
In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study.
Statement for Consent Form at Relying Site (not Lead PI Site)
This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site.
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value
First or given name of the relying site PI
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value
Surname or family name of the relying site PI
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value
Professional and Academic degrees of the relying site PI
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
Relying site PI's Academic or Professional Institution
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value
10-digit phone number, including area code
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
Information on how to contact the Site PI.
Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site
Public or private entity conducting the study- where the participant will go or call
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value
Information about institution for the site where study will be conducted
Lead Principal Investigator and Lead Principal Investigator Site
Statement about Lead PI and Lead PI Site for Consent Form at Relying Site
In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information.
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
Professional and Academic degrees of the lead PI
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
Information on how to contact the Lead PI.
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.
%lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value
Public or private entity associated with the lead principal investigator conducting the overall study.
%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.item.where(repeat(item).where(linkId = 'in5.1' and answer.value.code = 'SFS')).repeat(item).where(linkId = 'in5.2').answer.value
%resource.repeat(item).where(linkId = 'ExternalDataFor_c4.1').answer.value
Entity financially supporting the research
Any additional relevant information about the sponsor(s)
Describes the basic purpose, procedures and reasons behind the research in easily understood prose
Section header for the mandated text describing the basic purpose, procedures and reasons for the study.
This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate.
Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process.
Explanation about why the study is being conducted
Statement of whom the participant can anticipate interacting with during study participation
High level information about what participating in the study will entail for the participant
The total number of people targeted for enrollment in the multi-site study
Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site
High level information about what participating in the study will entail for the participant.
Additional text to provide additional context about the assessments collected
Do you want to upload the "Assessment List" table instead of typing the assessments directly into this questionnaire?
If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Assessment List" table in the questionnaire.
Describe the file that is being attached (optional)
Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.
Unique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final
Description of Visit types, including what procedures it contains
Choices for visit duration units are minutes (min), hours (h) or days (d).
Do you want to upload the "Visit List" table instead of typing the visits directly into this questionnaire?
If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Visit List" table in the questionnaire.
Specify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week.
Specify the procedure duration in minutes
Additional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule
Do you want to upload the "Procedure List" table instead of typing the procedures directly into this questionnaire?
If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Procedure List" table in the questionnaire.
Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion
Do you want to upload the "Risk List" table instead of typing the risks directly into this questionnaire?
If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Risk List" table in the questionnaire.
Additional text for description of other risks
Indicates whether risks to the fetus are possible
Textual description of risks to the fetus
Describe any other treatment/procedure that may be used other than those described for study participation.
Do you want to upload the "Benefits List" table instead of typing the benefits directly into this questionnaire?
Will there be compensation for participation?
Indicates whether compensation will be offered or not for the study
Additional text about compensation not captured in the compensation table
What types of visits or milestones will I be compensated for?
How many visits or milestones of this type will there be compensation for?
How much will be paid per that type of visit?
Do you want to upload the "Compensation List" table instead of typing the risks directly into this questionnaire?
If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the "Compensation List" table in the questionnaire.
What are the costs of participation, if any?
Explanation informing participant if any additional costs will occur to the participant as a result of taking part in the study
Will there be reimbursement for other study visit costs incurred?
Reimbursement to participant for other study visit costs not directly associated with a visit
Will costs be covered for medical treatment if research related injury occurs?
Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury
Additional description of treatment coverage
Description of other costs not directly associated with a visit
Participant Rights and whom to contact for answers
%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.10').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.3').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.4').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.5').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.6').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.7').answer.value
Contact information for the site IRB contact.
Study Coordinator Institution or Organization
Contact information for the study coordinator
Site Principal Investigator Contact Information
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.where(linkId = 'in8.10').answer.value
%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value
Contact information for the PI. May be replicated from above.
Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
Standard prepopulated statement, can be edited.
What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.
Anticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent
Are there consequences to participant for early withdrawal?
Are there Emotional Consequences of Withdrawal
Are there Physical Consequences of Withdrawal
What are the consequences of withdrawal?
Description of the withdrawal consequences, will depend and vary based on type of study.
Will HIPAA content be included within this document?
Medical information and billing statement
Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.
If template information required for your state differs from text provided, reword to satisfy state requirements.
Indicates if records identifying a subject will be maintained.
Explanation about processes and procedures to support maintaining privacy and confidentiality
Are there data security or policies that need to be included in the consent, particularly around device use (optional)
Indicates if any data security policy applies to this consent, including device use.
Describe any data security policies and processes protecting the data
Optional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection
Who can use or see participant information?
Role or group who will have access to data
Researchers outside the study team at this institution
Will the data be released for future use?
Indicates whether these data will be used beyond the study window
Will the future use data be deidentified?
Indicates if shared data will retain any identifiers.
Description of deidentification details for future use datasets.
Required text disclosure surrounding future use.
Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.
Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.
Select the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements.
Were specimens collected as part of this study?
Is whole genome sequencing being conducted?
Indicator of if genome sequencing is being conducted in conjunction with study
Indicator of whether biospecimens will be shared outside of the immediate study team or institution.
Textual description of sharing conditions including, type, when, etc.
Will participant share in profit with commerical use?
Indicator of any plans to profit share any funds received as a result of commercial use of those samples.
Textual description of collection and storage procedures and policies for the study.
Indicator of revocation of sample consent is an option
Will there be Broad Consent for Storage, maintenance and secondary research use?
Statement of Broad Consent for Storage, maintenance and secondary research use
Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose.
Can the study team contact you for future research?
Conditions about contact for additional sample use, information not currently described or future research
Description of the details for which the participant could be contacted
Indicator if the participant contact information can be used for future questions or recuitment for this or other studies
Will participants share in commercial profit?
Details about any profit sharing agreements or why profits will not be shared.
Indicator of participants will receive any commercial profits resulting from their participation in study
Will the study team contact you with new information that may affect your willingness to remain in the study
Indicator if study team will provide updates that may affect willingness to remain in study
Will the study team disclose clinically relevant study results to you?
Condtions under which the study results will be disclosed to you
Textual description of which results and when will be disclosed to you.
Indicator of study team will provide results of lab tests or other feedback of results to you at any time.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Is this study covered under a Certificate of Confidentiality? (default Y in NIH)
Certificate of Confidentiality Statement
The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]
Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)
Add any required text per your state laws.
When will the PHI Authorization Expire based on date or time past an event
PHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.
Statement of PHI Authorization Revocation
Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.
Indicator to include Participant Signature and Date/Time
Indicator to include Assent Signature and Date/Time
Indicator to include Legally Authorized Representative Signature and Date/Time
Relationship of Legally Authorized Representative
Indicator to include a Witness Signature and Date/Time
Indicator to include Parent 1 Signature and Date/Time
Indicator to include Parent 2 Signature and Date/Time
Date that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.
A number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.
Other attachments that will be included in the Consent Form that will be provided to the participants should be included here.
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
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