Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## Questionnaire: Initiate a Study Questionnaire

Official URL: http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate | Version: 1.0.0
Draft as of 2023-04-24 | Computable Name: SIRBInitiateAStudyQuestionnaire

Initiate a Study Questionnaire

Structure

LinkId | Text | Cardinality | Type | Flags | Description & Constraints
--- | --- | --- | --- | --- | ---
SIRBInitiateAStudyQuestionnaire | Initiate a Study Questionnaire |  | Questionnaire |  | http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0
in1 | Research Study Details | 0..1 | group |  |
in1.1 | Study Title | 1..1 | string |  |
in1.1_help | The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s) | 0..1 | display |  |
in1.2 | Study Title (Short) | 1..1 | string |  |
in1.2_help | A short study title written in language intended for the lay public. | 0..1 | display |  |
in1.3 | IRB Protocol Number | 1..1 | string |  |
in1.3_help | The Protocol Number assigned by the sIRB | 0..1 | display |  |
in1.4 | Study Type | 1..1 | choice |  | Options: 2 options
in1.4_help | Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional) | 0..1 | display |  |
DIVIDER1 | null | 0..1 | display |  |
in5 | Other Organization(s) Involved | 0..* | group |  |
in5.1 | Relationship Type | 1..1 | choice |  | Options: 2 options
in5.1_help | Select the organization's type of involvement in the study | 0..1 | display |  |
in5.2 | Organization Name | 1..1 | string |  |
in5.2_help | e.g. NIH or company name | 0..1 | display |  |
in5.3 | Phone | 0..1 | string |  |
in5.3_help | 10 digit phone number, including area code | 0..1 | display |  |
in5.4 | Sponsor or Funding Source Protocol Number, if applicable | 0..1 | string |  |
in5.4_help | Unique Protocol Identification Number used by the sponsor, if applicable | 0..1 | display |  |
in5.5 | Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) | 0..1 | string |  | Expressions: Calculated Value: `%combinedOtherOrgUniqueOneRepetition`
in5.6 | Protocol Number with Organization Name (read-only) | 0..1 | string |  | Expressions: Calculated Value: `%otherOrgProtocolWithNameOneRepetition`
DIVIDER2 | null | 0..1 | display |  |
in6 | sIRB (Reviewing Institution) | 0..1 | group |  |
in6.1 | sIRB (Reviewing Institution) Name | 1..1 | string |  |
in6.1_help | Name of the sIRB (Reviewing Institution) | 0..1 | display |  |
in6.10 | Department Name or Division | 0..1 | string |  |
in6.10_help | The department name or division of the sIRB, if applicable | 0..1 | display |  |
in6.3 | Institution Street Address | 1..1 | string |  |
in6.3_help | Physical address of the sIRB (Reviewing Institution) | 0..1 | display |  |
in6.4 | Institution City | 1..1 | string |  |
in6.5 | Institution State | 1..1 | string |  |
in6.6 | Institution Zip Code | 1..1 | string |  |
in6.7 | Institution Country | 0..1 | string |  | Initial Value: string = United States
in6.8 | Is a Federal Wide Assurance (FWA) Number assigned? | 1..1 | choice |  | Options: 4 options
in6.8_help | DHHS 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..1 | display |  |
in6.9 | Federal Wide Assurance Number (if assigned) | 0..1 | integer |  | Enable When: in6.8 = Yes (expandedYes-NoIndicator#Y)
in6.9_help | If assigned, enter just numeric value of FWA. | 0..1 | display |  |
in6.11 | Is the sIRB a 3rd party institution? | 0..1 | choice |  | Options: 2 options
in6.11_help | Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution? | 0..1 | display |  |
DIVIDER3 | null | 0..1 | display |  |
in7 | Lead Principal Investigator | 0..1 | group |  |
in7.1 | Lead Principal Investigator Institution | 0..1 | group |  |
in7.1.1 | Lead Principal Investigator Institution Name | 1..1 | string |  |
in7.1.1_help | Name of institution for the lead principal investigator | 0..1 | display |  |
in7.1.10 | Department Name or Division | 0..1 | string |  |
in7.1.10_help | The department name or division of the lead principal investigator | 0..1 | display |  |
in7.1.3 | Institution Phone | 0..1 | string |  |
in7.1.3_help | 10-digit phone number, including area code, for the institution of the lead principal investigator | 0..1 | display |  |
in7.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | 1..1 | choice |  | Options: 4 options
in7.1.4_help | DHHS 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..1 | display |  |
in7.1.5 | Federal Wide Assurance Number (if assigned) | 0..1 | integer |  | Enable When: in7.1.4 = Yes (expandedYes-NoIndicator#Y)
in7.1.5_help | If assigned, enter just numeric value of FWA. | 0..1 | display |  |
in7.3 | Lead Principal Investigator | 0..1 | group |  |
in7.3.1 | Lead Principal Investigator First Name | 1..1 | string |  |
in7.3.1_help | First Name or Given Name of the lead PI responsible for the overall study | 0..1 | display |  |
in7.3.2 | Lead Principal Investigator Last Name | 1..1 | string |  |
in7.3.2_help | Last name, surname or family name of the lead PI responsible for the overall study | 0..1 | display |  |
in7.3.3 | Lead Principal Investigator Suffix | 0..1 | string |  |
in7.3.3_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
in7.3.4 | Academic and Professional Degrees associated with the Lead Principal Investigator | 1..1 | string |  |
in7.3.4_help | Academic and Professional degrees associated with the lead principal investigator | 0..1 | display |  |
in7.3.10 | Department Name or Division | 0..1 | string |  |
in7.3.10_help | The department name or division of the lead PI | 0..1 | display |  |
in7.3.5 | Phone | 0..1 | string |  |
in7.3.5_help | 10-digit phone number, including area code, for the lead principal investigator | 0..1 | display |  |
in7.3.6 | Email address | 0..1 | string |  |
in7.3.6_help | Email address associated with the lead principal investigator | 0..1 | display |  |
in7.3.7 | Address of Lead Principal Investigator | 0..1 | group |  |
in7.3.7.1 | Street Address | 0..1 | string |  |
in7.3.7.1_help | Physical address | 0..1 | display |  |
in7.3.7.2 | City | 1..1 | string |  |
in7.3.7.3 | State | 1..1 | string |  |
in7.3.7.4 | Zip Code | 0..1 | string |  |
in7.3.7.5 | Country | 0..1 | string |  | Initial Value: string = United States
in7.9 | Lead Principal Investigator Unique Site (read-only) | 0..1 | string |  | Expressions: Calculated Value: `%combinedLeadPIUniqueSite`
in7.10 | Lead Principal Investigator Full Name, Suffix and Degrees | 0..1 | string |  | Expressions: Calculated Value: `%fullNameDSLeadPI`
DIVIDER4 | null | 0..1 | display |  |
in8 | Relying Site(s) | 0..* | group |  |
in8.5 | Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator | 0..1 | group |  |
in8.5.1 | Is this relying site at the same institution as where the lead principal investigator is conducting the study? | 0..1 | choice |  | Options: 2 options
in8.5.1_help | This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank. | 0..1 | display |  |
in8.5.2 | Is this relying site at the same site as where the lead principal investigator is conducting the study? | 0..1 | choice |  | Enable When: in8.5.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options
in8.5.2_help | This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank. | 0..1 | display |  |
in8.5.3 | Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? | 0..1 | choice |  | Options: 2 options
in8.5.3_help | This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank. | 0..1 | display |  |
in8.5.4 | Is this relying site also considered to be the lead site for the study? | 1..1 | choice |  | Options: 2 options
in8.5.4_help | Indicator that the lead PI site where the study is being conducted is also participating as this relying site | 0..1 | display |  |
in8.1 | Relying Site Institution | 0..1 | group |  |
in8.1.1 | Relying Institution Name | 1..1 | string |  | Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)`
in8.1.1_help | Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions. | 0..1 | display |  |
in8.1.10 | Department Name or Division | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)`
in8.1.10_help | The department name or division for the relying site | 0..1 | display |  |
in8.1.3 | Relying Institution Phone | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)`
in8.1.3_help | 10-digit phone number, including area code, for the relying institution | 0..1 | display |  |
in8.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | 1..1 | choice |  | Options: 4 options Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)`
in8.1.4_help | DHHS 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..1 | display |  |
in8.1.5 | Federal Wide Assurance Number (if assigned) | 0..1 | integer |  | Enable When: in8.1.4 = Yes (expandedYes-NoIndicator#Y) Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)`
in8.1.5_help | If assigned, enter just numeric value of FWA. | 0..1 | display |  |
in8.1.6 | Reliance Status | 1..1 | choice |  | Options: 5 options
in8.1.6_help | Status of the reliance agreement | 0..1 | display |  |
in8.1_help | Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB) | 0..1 | display |  |
in8.3 | Relying Site Principal Investigator | 0..1 | group |  |
in8.3.1 | Relying Site Principal Investigator First Name | 1..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)`
in8.3.1_help | First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution | 0..1 | display |  |
in8.3.2 | Relying Site Principal Investigator Last Name | 1..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value)`
in8.3.2_help | Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution | 0..1 | display |  |
in8.3.3 | Relying Site Principal Investigator Suffix | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)`
in8.3.3_help | Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. | 0..1 | display |  |
in8.3.4 | Academic and Professional Degrees associated with the Relying Site Principal Investigator | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)`
in8.3.4_help | Academic and Professional degrees associated with the relying site principal investigator | 0..1 | display |  |
in8.3.10 | Department Name or Division | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)`
in8.3.10_help | The department name or division for the relying site PI | 0..1 | display |  |
in8.3.5 | Phone | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)`
in8.3.5_help | 10-digit phone number, including area code, for the relying site principal investigator | 0..1 | display |  |
in8.3.6 | Email address | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)`
in8.3.6_help | Email address associated with the relying site principal investigator | 0..1 | display |  |
in8.3.7 | Address of Relying Site Principal Investigator | 0..1 | group |  |
in8.3.7.1 | Street Address | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)`
in8.3.7.1_help | Physical address | 0..1 | display |  |
in8.3.7.2 | City | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)`
in8.3.7.3 | State | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)`
in8.3.7.4 | Zip Code | 0..1 | string |  | Expressions: Calculated Value: `iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)`
in8.3.7.5 | Country | 0..1 | string |  | Initial Value: string = United States
in8.3_help | Principal Investigator responsible for the conduct of the study at a specific relying site research location. | 0..1 | display |  |
in8.9 | Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) | 0..1 | string |  | Expressions: Calculated Value: `%combinedSitePIUniqueSiteOneRepetition`
in8.10 | Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) | 0..1 | string |  | Expressions: Calculated Value: `%fullNameDSSitePIOneRepetition`
in8_help | The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here. | 0..1 | display |  |
DIVIDER5 | null | 0..1 | display |  |
in9 | FDA exemption and IDE/IND Number | 0..1 | group |  |
in9.1 | Does this study require a FDA exemption? | 0..1 | choice |  | Options: 2 options
in9.1_help | Indicator for use of FDA regulated product | 0..1 | display |  |
in9.2 | Is an IND or IDE being used in this study? | 0..1 | choice |  | Options: 2 options
in9.2_help | Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used? | 0..1 | display |  |
in9.4 | Please select IND or IDE: | 0..1 | choice |  | Enable When: in9.2 = Yes (expandedYes-NoIndicator#Y) Options: 2 options
in9.4_help | Select IND for Investigational New Drug or IDE for Investigational Device Exemption | 0..1 | display |  |
in9.3 | IND/IDE Number | 0..1 | string |  | Enable When: in9.2 = Yes (expandedYes-NoIndicator#Y)
DIVIDER6 | null | 0..1 | display |  |
in10 | Questionnaire Version Details | 0..1 | group |  |
in10.1 | Questionnaire Version | 1..1 | string |  | Initial Value: string = 2
in10.2 | Questionnaire Version Date | 1..1 | date |  | Initial Value: date = 2021-10-18
DIVIDER7 | null | 0..1 | display |  |
ADMIN00 | Administrative Use Only (will be hidden in the future) | 0..1 | group |  |
ADMIN01 | Link ID prefix | 0..1 | string |  | Initial Value: string = in
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
ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses | 0..1 | string |  | Initial Value: string = temporarily unavailable
ADMIN04 | Questionnaire Response ID of the local considerations Questionnaire Response, if any | 0..1 | string |  |
Documentation for this format

Option Sets

Answer options for in1.4

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational")

Answer options for in5.1

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SFS ("Sponsor or Funding Source")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CRO ("Contract Research Organization (CRO)")

Answer options for in6.8

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
- http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
- http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")

Answer options for in6.11

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in7.1.4

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
- http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
- http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")

Answer options for in8.5.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in8.5.2

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in8.5.3

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in8.5.4

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in8.1.4

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
- http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
- http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")

Answer options for in8.1.6

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#APPROVED ("Approved for reliance")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DENIED ("Denied reliance")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#POSSIBLE ("Potential/possible")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CANCELLED ("Cancelled or not participating")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ONHOLD ("Temporarily on hold")

Answer options for in9.1

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in9.2

- http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
- http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for in9.4

- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND")
- http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")