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

## Other

The following sections are included as part of the HL7 initiative to provide increased transparency regarding cross-version compatibility, global profiles, dependencies and intellectual property.

### Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.fhir.us.sirb.r4) and R4B (hl7.fhir.us.sirb.r4b) are available.

### IG Dependencies

IG | Package | FHIR | Comment
--- | --- | --- | ---
Single Institutional Review Board (sIRB) Implementation Guide | hl7.fhir.us.sirb#1.0.0 | R4 |
HL7 Terminology (THO) | hl7.terminology.r4#5.0.0 | R4 | Automatically added as a dependency - all IGs depend on HL7 Terminology
Structured Data Capture | hl7.fhir.uv.sdc#3.0.0 | R4 |
FHIR R4 package : Examples | hl7.fhir.r4.examples#4.0.1 | R4 |

Package hl7.fhir.r4.examples#4.0.1 Example resources in the R4 version of the FHIR standard

Package hl7.fhir.uv.sdc#3.0.0 The SDC specification provides an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR. This includes two components: * Support more sophisticated questionnaire/form use-cases such as those needed for research, oncology, pathology and other clinical domains. *Support pre-population and auto-population of EHR data into forms/questionnaires for uses outside direct clinical care (patient safety, adverse event reporting, public health reporting, etc.). (built Tue, Mar 8, 2022 18:32+0000+00:00)

### Globals Table

There are no Global profiles defined

### Copyright/Legal

- See the Copyright/Legal section on the Descriptions of CodeSystems page.

- Review the following notices:

This publication includes IP covered under the following statements.

- Copyright HL7. Licensed under creative commons public domain
  Show Usage
  - administrativeSex: AE_Questionnaire and QuestionnaireResponse/medical-ae-populate-exampleQR
  - relationship: Consent_Questionnaire
  - eventExpected: AE_Questionnaire and QuestionnaireResponse/medical-ae-populate-exampleQR
  - actionTakenInResponseToTheEvent: AE_Questionnaire and QuestionnaireResponse/medical-ae-populate-exampleQR
  - expandedYes-NoIndicator: AE_Questionnaire, Consent_Questionnaire... Show 12 more, Continuing_review, NonMedical_events, Protocol_questionnaire, QuestionnaireResponse/consent-form-populate-exampleQR, QuestionnaireResponse/continuing-review-populate-exampleQR, QuestionnaireResponse/initiate-study-populate-exampleQR, QuestionnaireResponse/medical-ae-populate-exampleQR, QuestionnaireResponse/nme-populate-exampleQR, QuestionnaireResponse/protocol-populate-exampleQR, QuestionnaireResponse/recruitment-populate-exampleQR, RecruitmentMaterials and SIRBInitiateAStudyQuestionnaire
- ISO Maintains the copyright on the country codes, and controls it's use carefully. For futher details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
  Show Usage
  - ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code: AE_Questionnaire, CapabilityStatementClient_sIRB... Show 10 more, CapabilityStatementServer_sIRB, Consent_Questionnaire, Continuing_review, NonMedical_events, Protocol_questionnaire, RecruitmentMaterials, SIRBDeterminationQuestionnaire, SIRBInitiateAStudyQuestionnaire, SingleInstitutionalReviewBoard and TemporaryCodes
- The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
  Show Usage
  - Unified Code for Units of Measure (UCUM): Consent_Questionnaire and QuestionnaireResponse/consent-form-populate-exampleQR