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 Server Capability Statement

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

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

Raw OpenAPI-Swagger Definition file | Download

## sIRB Server Capability Statement

(Requirements Definition Capability Statement)

Canonical URL: http://hl7.org/fhir/us/sirb/CapabilityStatement/sIRB-CapabilityStatementServer 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 FHIR servers for use and exchange of the single Institutional Review Board (sIRB) forms.

## General

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

## REST server behavior

Requirements for the sIRB FHIR Server that stores the Questionnaires and the QuestionnaireResponses. The FHIR Server is generally, but not always, hosted by the lead principal investigator's institution.

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 |  | MAY | MAY |  |
QuestionnaireResponse | SHOULD | SHALL | SHALL | MAY |  | SHALL | SHALL |  |
ResearchStudy | MAY | MAY | MAY | MAY |  | MAY | MAY |  |
Provenance | MAY | MAY | MAY | MAY |  | MAY | MAY |  |

### Questionnaire

#### Behavior

Versioning support: versioned-update

#### 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 |