Single Institutional Review Board (sIRB) Implementation Guide
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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

Example QuestionnaireResponse: Example Initiate a Study Questionnaire Response

LinkIdTextDefinitionAnswerdoco
.. initiate-study-populate-exampleQRQuestionnaireResponse
... in1Research Study Details
.... in1.1Study TitleA clinical study of the efficacy of Drug A for arthritis
.... in1.2Study Title (Short)Study of Drug A for arthritis
.... in1.3IRB Protocol NumberPRO098765
.... in1.4Study TypeTemporary Codes INT: Interventional
... in5Other Organization(s) Involved
.... in5.1Relationship TypeTemporary Codes SFS: Sponsor or Funding Source
.... in5.2Organization NameNational Government Funder
.... in5.3Phone800-123-1234
.... in5.4Sponsor or Funding Source Protocol Number, if applicableGov-123456
.... in5.5Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source
.... in5.6Protocol Number with Organization Name (read-only)Gov-123456 (National Government Funder)
... in5Other Organization(s) Involved
.... in5.1Relationship TypeTemporary Codes SFS: Sponsor or Funding Source
.... in5.2Organization NameOrganization of Arthritis Patients Foundation
.... in5.3Phone123-123-1234
.... in5.5Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source
.... in5.6Protocol Number with Organization Name (read-only)(Organization of Arthritis Patients Foundation)
... in5Other Organization(s) Involved
.... in5.1Relationship TypeTemporary Codes CRO: Contract Research Organization (CRO)
.... in5.2Organization NameSample CRO, Inc.
.... in5.3Phone234-123-1234
.... in5.5Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO)
.... in5.6Protocol Number with Organization Name (read-only)(Sample CRO, Inc.)
... in6sIRB (Reviewing Institution)
.... in6.1sIRB (Reviewing Institution) NameX Pharmaceutical Research IRB
.... in6.3Institution Street Address210 Research Drive
.... in6.4Institution CitySample City
.... in6.5Institution StateNC
.... in6.6Institution Zip Code27612
.... in6.7Institution CountryUnited States
.... in6.8Is a Federal Wide Assurance (FWA) Number assigned?expandedYes-NoIndicator Y: Yes
.... in6.9Federal Wide Assurance Number (if assigned)12345
.... in6.11Is the sIRB a 3rd party institution?expandedYes-NoIndicator Y: Yes
... in7Lead Principal Investigator
.... in7.1Lead Principal Investigator Institution
..... in7.1.1Lead Principal Investigator Institution NameSample University Medical Center
..... in7.1.4Is a Federal Wide Assurance (FWA) Number assigned?expandedYes-NoIndicator Y: Yes
..... in7.1.5Federal Wide Assurance Number (if assigned)56789
.... in7.3Lead Principal Investigator
..... in7.3.1Lead Principal Investigator First NameJane
..... in7.3.2Lead Principal Investigator Last NameDoe
..... in7.3.4Academic and Professional Degrees associated with the Lead Principal InvestigatorMD
..... in7.3.10Department Name or DivisionOrthopedics
..... in7.3.5Phone567-123-1234
..... in7.3.6Email addressdrjanedoe@sampleuniversity.edu
..... in7.3.7Address of Lead Principal Investigator
...... in7.3.7.1Street Address105 Sample University Ct.
...... in7.3.7.2CitySample City
...... in7.3.7.3StateNC
...... in7.3.7.4Zip Code27612
...... in7.3.7.5CountryUnited States
.... in7.9Lead Principal Investigator Unique Site (read-only)Sample University Medical Center | | Jane Doe, MD | Sample City, NC
.... in7.10Lead Principal Investigator Full Name, Suffix and DegreesJane Doe, MD
... in8Relying Site(s)
.... in8.5Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
..... in8.5.1Is this relying site at the same institution as where the lead principal investigator is conducting the study?expandedYes-NoIndicator Y: Yes
..... in8.5.2Is this relying site at the same site as where the lead principal investigator is conducting the study?expandedYes-NoIndicator Y: Yes
..... in8.5.3Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?expandedYes-NoIndicator Y: Yes
..... in8.5.4Is this relying site also considered to be the lead site for the study?expandedYes-NoIndicator Y: Yes
.... in8.1Relying Site Institution
..... in8.1.1Relying Institution NameSample University Medical Center
..... in8.1.4Is a Federal Wide Assurance (FWA) Number assigned?expandedYes-NoIndicator Y: Yes
..... in8.1.5Federal Wide Assurance Number (if assigned)56789
..... in8.1.6Reliance StatusTemporary Codes APPROVED: Approved for reliance
.... in8.3Relying Site Principal Investigator
..... in8.3.1Relying Site Principal Investigator First NameJane
..... in8.3.2Relying Site Principal Investigator Last NameDoe
..... in8.3.4Academic and Professional Degrees associated with the Relying Site Principal InvestigatorMD
..... in8.3.10Department Name or DivisionOrthopedics
..... in8.3.5Phone567-123-1234
..... in8.3.6Email addressdrjanedoe@sampleuniversity.edu
..... in8.3.7Address of Relying Site Principal Investigator
...... in8.3.7.1Street Address105 Sample University Ct.
...... in8.3.7.2CitySample City
...... in8.3.7.3StateNC
...... in8.3.7.4Zip Code27612
...... in8.3.7.5CountryUnited States
.... in8.9Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)Sample University Medical Center | | Jane Doe, MD | Sample City, NC
.... in8.10Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)Jane Doe, MD
... in8Relying Site(s)
.... in8.5Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
..... in8.5.1Is this relying site at the same institution as where the lead principal investigator is conducting the study?expandedYes-NoIndicator N: No
..... in8.5.3Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?expandedYes-NoIndicator N: No
..... in8.5.4Is this relying site also considered to be the lead site for the study?expandedYes-NoIndicator N: No
.... in8.1Relying Site Institution
..... in8.1.1Relying Institution NameTest Example University
..... in8.1.3Relying Institution Phone6781233456
..... in8.1.4Is a Federal Wide Assurance (FWA) Number assigned?expandedYes-NoIndicator Y: Yes
..... in8.1.5Federal Wide Assurance Number (if assigned)34567
..... in8.1.6Reliance StatusTemporary Codes POSSIBLE: Potential/possible
.... in8.3Relying Site Principal Investigator
..... in8.3.1Relying Site Principal Investigator First NameXi-Yang
..... in8.3.2Relying Site Principal Investigator Last NameLee
..... in8.3.3Relying Site Principal Investigator SuffixJr.
..... in8.3.4Academic and Professional Degrees associated with the Relying Site Principal InvestigatorMD, PhD
..... in8.3.5Phone6781233456
..... in8.3.6Email addressXiYangLee@teu.med.edu
..... in8.3.7Address of Relying Site Principal Investigator
...... in8.3.7.1Street Address200 Test Example Circle
...... in8.3.7.2CityExample
...... in8.3.7.3StateMA
...... in8.3.7.4Zip Code67890
...... in8.3.7.5CountryUnited States
.... in8.9Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
.... in8.10Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)Xi-Yang Lee, Jr., MD, PhD
... in8Relying Site(s)
.... in8.5Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator
..... in8.5.1Is this relying site at the same institution as where the lead principal investigator is conducting the study?expandedYes-NoIndicator N: No
..... in8.5.3Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?expandedYes-NoIndicator N: No
..... in8.5.4Is this relying site also considered to be the lead site for the study?expandedYes-NoIndicator N: No
.... in8.1Relying Site Institution
..... in8.1.1Relying Institution NameCentral Campus Test University
..... in8.1.4Is a Federal Wide Assurance (FWA) Number assigned?expandedYes-NoIndicator NI: No Information
..... in8.1.6Reliance StatusTemporary Codes POSSIBLE: Potential/possible
.... in8.3Relying Site Principal Investigator
..... in8.3.1Relying Site Principal Investigator First NameMaria
..... in8.3.2Relying Site Principal Investigator Last NameSmith
..... in8.3.4Academic and Professional Degrees associated with the Relying Site Principal InvestigatorPhD
..... in8.3.5Phone8901231234
..... in8.3.6Email addressmaria.smith@CCTU.med.edu
..... in8.3.7Address of Relying Site Principal Investigator
...... in8.3.7.1Street Address200 Central St.
...... in8.3.7.2CityCentral
...... in8.3.7.3StateMI
...... in8.3.7.4Zip Code23456
...... in8.3.7.5CountryUnited States
.... in8.9Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)Central Campus Test University | | Maria Smith, PhD | Central, MI
.... in8.10Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)Maria Smith, PhD
... in9FDA exemption and IDE/IND Number
.... in9.1Does this study require a FDA exemption?expandedYes-NoIndicator Y: Yes
.... in9.2Is an IND or IDE being used in this study?expandedYes-NoIndicator Y: Yes
.... in9.4Please select IND or IDE:Temporary Codes IND: IND
.... in9.3IND/IDE Number432fdw512432fqsdf
... in10Questionnaire Version Details
.... in10.1Questionnaire Version2
.... in10.2Questionnaire Version Date2021-10-18
... ADMIN00Administrative Use Only (will be hidden in the future)
.... ADMIN01Link ID prefixin
.... ADMIN02Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if anyinitiate-study-populate-exampleQR
.... ADMIN03ID of the Research Study FHIR Resource associated with the study Questionnaire ResponsesResearchStudyExample-sIRB

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