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

## CapabilityStatement: sIRB Client Capability Statement

Official URL: http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementClient | Version: 1.0.0
Draft as of 2022-10 | Computable Name: CapabilityStatementClient_sIRB

This resource describes the required and desired behavior of software clients for use and exchange of the single Institutional Review Board (sIRB) forms.

Raw OpenAPI-Swagger Definition file | Download

## sIRB Client Capability Statement

(Requirements Definition Capability Statement)

Canonical URL: http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementClient Version: 0.1.0 Published: 2022-10 (draft)

Published by: HL7 International - BR&R Work Group

This resource describes the required and desired behavior of software clients for use and exchange of the single Institutional Review Board (sIRB) forms.

## General

FHIR Version: | 4.0.1
Supported formats: | xml, json

## REST client behavior

Requirements for the REST FHIR Questionnaire Management Software (could be the research study system of the lead principal investigator's institution, another type of software or the sIRB on FHIR software).

Security:

Review the security recommendations on the FHIR Security page at http://hl7.org/fhir/R4/security.html

### Resource summary

Resource | Search | Read | Read Version | Instance History | Resource History | Create | Update | Delete | Operations
--- | --- | --- | --- | --- | --- | --- | --- | --- | ---
Questionnaire | SHOULD | SHALL |  | MAY |  |  |  |  |
QuestionnaireResponse | SHOULD | SHALL | SHALL | MAY |  | SHALL | SHALL |  |
ResearchStudy | MAY | MAY | MAY | MAY |  | MAY | MAY |  |
Provenance | MAY | MAY | MAY | MAY |  | MAY | MAY |  |

### Questionnaire

#### Interactions

Name | Conformance | Description
--- | --- | ---

#### Search

Parameter | Conformance | Type | Definition & Chaining
--- | --- | --- | ---
url | SHALL | uri |
version | SHOULD | token |
status | SHOULD | token |
_lastUpdated | SHOULD | date |
_id | MAY | token |

### QuestionnaireResponse

#### Behavior

Versioning support: versioned-update

#### Interactions

Name | Conformance | Description
--- | --- | ---

#### Search

Supported Includes: QuestionnaireResponse.questionnaire

Parameter | Conformance | Type | Definition & Chaining
--- | --- | --- | ---
questionnaire | SHALL | reference |
author | SHALL | reference |
_lastUpdated | SHALL | date |
_id | MAY | token |
identifier | SHOULD | token |
status | SHALL | token |

### ResearchStudy

#### Behavior

Versioning support: versioned-update

#### Interactions

Name | Conformance | Description
--- | --- | ---

#### Search

Parameter | Conformance | Type | Definition & Chaining
--- | --- | --- | ---
identifier | MAY | token |
_id | MAY | token |
title | MAY | string |
keyword | MAY | token |

### Provenance

#### Behavior

Versioning support: versioned-update

#### Interactions

Name | Conformance | Description
--- | --- | ---

#### Search

Parameter | Conformance | Type | Definition & Chaining
--- | --- | --- | ---
_id | MAY | token |
target | SHOULD | reference |
when | SHOULD | date |