Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example Questionnaire: Initiate a Study Questionnaire

This questionnaire serves as an initial collection form for recurring data elements that are present in the other forms. These other forms will then subsequently prepopulate with these data to minimize data entry time and errors.

Structure
LinkIdTextCardinalityTypeFlagsDescription & Constraintsdoco
.. SIRBInitiateAStudyQuestionnaireQuestionnaireInitiate a Study Questionnaire
... in1Research Study Details0..1group
.... in1.1Study Title1..1string
..... in1.1-helpThe official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)0..1display
.... in1.2Study Title (Short)1..1string
..... in1.2-helpA short study title written in language intended for the lay public.0..1display
.... in1.3IRB Protocol Number1..1string
..... in1.3-helpThe Protocol Number assigned by the sIRB0..1display
.... in1.4Study Type1..1choiceOptions: 2 options
..... in1.4-helpSelect the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)0..1display
... DIVIDER1null0..1display
... in5Other Organization(s) Involved0..*group
.... in5.1Relationship Type1..1choiceOptions: 2 options
..... in5.1-helpSelect the organization's type of involvement in the study0..1display
.... in5.2Organization Name1..1string
..... in5.2-helpe.g. NIH or company name0..1display
.... in5.3Phone0..1string
..... in5.3-helpPhone number, including area code0..1display
.... in5.4Sponsor or Funding Source Protocol Number, if applicable0..1string
..... in5.4-helpUnique Protocol Identification Number used by the sponsor, if applicable0..1display
... DIVIDER2null0..1display
... in6sIRB (Reviewing Institution)0..1group
.... in6.1sIRB (Reviewing Institution) Name1..1string
..... in6.1-helpName of the sIRB (Reviewing Institution)0..1display
.... in6.3Institution Street Address1..1string
..... in6.3-helpPhysical address of the sIRB (Reviewing Institution)0..1display
.... in6.4Institution City1..1string
.... in6.5Institution State1..1string
.... in6.6Institution Zip Code1..1string
.... in6.7Institution Country1..1stringInitial Value: string = United States
.... in6.8Is a Federal Wide Assurance (FWA) Number assigned?1..1choiceOptions: 4 options
..... in6.8-helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".0..1display
.... in6.9Federal Wide Assurance Number (if assigned)0..1integerEnable When:
..... inin6.9-helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.0..1display
... DIVIDER3null0..1display
... in7Overall Principal Investigator for the Study0..1group
.... in7.1Overall Principal Investigator First Name1..1string
..... in7.1-helpThe first or given name associated with the overall principal investigator0..1display
.... in7.2Overall Principal Investigator Last Name1..1string
..... in7.2-helpLast name, surname or family name associated with the overall principal investigator0..1display
.... in7.3Overall Principal Investigator Suffix0..1string
..... in7.3-helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the overall principal investigator's name0..1display
.... in7.4Academic and Professional Degrees associated with the Overall Principal Investigator0..1string
..... in7.4-helpAcademic and Professional degrees associated with the overall principal investigator0..1display
.... in7.5Overall Principal Investigator Institution Name1..1string
..... in7.5-helpThe institution of the overall principal investigator0..1display
.... in7.6Department Name or Division0..1string
..... in7.6-helpThe department name or division for the overall principal investigator0..1display
.... in7.7Street Address1..1string
..... in7.7-helpPhysical address of the overall principal investigator0..1display
.... in7.8City1..1string
.... in7.9State1..1string
.... in7.10Zip Code1..1string
.... in7.11Country1..1stringInitial Value: string = United States
.... in7.12Overall Principal Investigator Phone1..1string
..... in7.12-helpPhone number, including area code for the overall principal investigator0..1display
.... in7.13Overall Principal Investigator Email Address1..1string
..... in7.13-helpEmail address associated with overall principal investigator0..1display
... DIVIDER4null0..1display
... in8Confirmed or Potential Relying Site(s)0..*group
.... in8.1Confirmed or Potential Relying Site Overview0..1group
..... in8.1.1Relying Institution Name0..1string
...... in8.1.1-helpName of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.0..1display
..... in8.1.3Relying Institution Phone0..1string
...... in8.1.3-helpPhone number, including area code for the relying institution0..1display
..... in8.1.4Is a Federal Wide Assurance (FWA) Number assigned?1..1choiceOptions: 4 options
...... in8.1.4-helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".0..1display
..... in8.1.5Federal Wide Assurance Number (if assigned)0..1integerEnable When:
...... in8.1.5-helpDHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.0..1display
..... in8.1.6Reliance Status1..1choiceOptions: 5 options
...... in8.1.6-helpStatus of the reliance agreement0..1display
..... in8.1-helpInstitutions for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.0..1display
..... in8.1.7Relying Site Address0..1group
...... in8.1.7.1Street Address0..1string
....... in8.1.7.1-helpPhysical address0..1display
...... in8.1.7.2City0..1string
...... in8.1.7.3State0..1string
...... in8.1.7.4Zip Code0..1string
...... in8.1.7.5Country0..1stringInitial Value: string = United States
.... in8.3Site Principal Investigator at Relying Site0..1group
..... in8.3.1Relying Site Principal Investigator First Name0..1string
...... in8.3.1-helpFirst Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution0..1display
..... in8.3.2Relying Site Principal Investigator Last Name0..1string
...... in8.3.2-helpLast name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution0..1display
..... in8.3.3Relying Site Principal Investigator Suffix0..1string
...... in8.3.3-helpSuffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the relying site principal investigator0..1display
..... in8.3.4Academic and Professional Degrees associated with the Relying Site Principal Investigator0..1string
...... in8.3.4-helpAcademic and Professional degrees associated with the relying site principal investigator0..1display
..... in8.3.5Phone0..1string
...... in8.3.5-helpPhone number, including area code for the relying site principal investigator0..1display
..... in8.3.6Email address0..1string
...... in8.3.6-helpEmail address associated with the relying site principal investigator0..1display
..... in8.3.7Address of Relying Site Principal Investigator0..1group
...... in8.3.7.1Street Address0..1string
....... in8.3.7.1-helpPhysical address0..1display
...... in8.3.7.2City0..1string
...... in8.3.7.3State0..1string
...... in8.3.7.4Zip Code0..1string
...... in8.3.7.5Country0..1stringInitial Value: string = United States
... DIVIDER5null0..1display
... in9Questionnaire Version Details0..1group
.... in9.1Questionnaire Version1..1stringInitial Value: string = 1
.... in9.2Questionnaire Version Date1..1dateInitial Value: date = 2021-06-01
... DIVIDER6null0..1display
... ADMIN00Administrative Use Only (will be hidden in the future)0..1group
.... ADMIN01Link ID prefix0..1stringInitial Value: string = in
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any0..1stringInitial Value: string = temporarily unavailable
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire Responses0..1stringInitial Value: string = temporarily unavailable
.... ADMIN04Questionnaire Response ID of the local considerations Questionnaire Response, if any0..1string

doco Documentation for this format

Option Sets

Answer options for in1.4

Answer options for in5.1

Answer options for in6.8

Answer options for in8.1.4

Answer options for in8.1.6