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

## Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

### Questionnaires

Initiate a Study Questionnaire | This questionnaire serves as an initial collection form for recurring data elements that are present in the other forms. These other forms will then subsequently prepopulate with these data to minimize data entry time and errors.
Protocol Questionnaire | The Protocol Questionnaire is used by the Principal Investigator and/or the Study Coordinator to justify the study and request the approval for the study. Contents include a synopsis for non-technical board members and a detailed protocol discussion. Other important sections of form requesting approval for the protocol include work history of the researchers, risks to university personnel performing the research, risk mitigations being undertaken by the researchers, long discussions of the existing body of knowledge and explanations of how the study can be rationalized in light of the existing knowledge on this study topic.
Consent Form Questionnaire | The Consent Form Questionnaire creates the exact Consent Form content word-for-word that will be shown to the sIRB’s Institutional Review Board to be approved to use during the study. The rendering and pdf format created by the software are also provided to the sIRB to be approved.
Recruitment Materials Questionnaire | The Recruitment Materials Form is used to seek approval from the sIRB to use the specified recruitment materials (at the requested time, place, duration and medium) during the study and for the methods of communication that are proposed for responding to the study participants.
Determination Letter Questionnaire | This questionnaire collects information required in the production of a determination letter. These data are used to send a Determination Letter Report to each site when a decision is made regarding the institution’s approval to serve as a relying site.
Continuing Review Questionnaire | The Continuing Review Questionnaire collects data used in a report which is then provided to the sIRB on a regular basis so that continued activity on the study can be reviewed.
Adverse Medical Event Questionnaire | The Adverse Events Questionnaire is intended to create a Medical Adverse Event Report to the sIRB to notify them of the Medical Adverse Event, the medical description of the event, the resolution of the event, whether there were associated protocol violations and the relationship of the medical event to the study agent.
Adverse Non-Medical Event Questionnaire | The Non-Medical Adverse Event Questionnaire is intended to create a Non-Medical Adverse Event Report to the sIRB. An example of a Non-Medical Adverse Event is the inadvertent disclosure to several participants that they are receiving the placebo in a blind study. The Non-Medical Adverse Event Questionnaire captures details for the report such as the root cause of the event, the corrective action plan and associated changes to the protocol or consent form as a result of the event.

### Examples of sIRB Questionnaire Responses

Example Adverse Non-Medical Event Questionnaire Response | Example of an Adverse Non-Medical Event Questionnaire Response
Example Protocol Questionnaire Response | Example of a Protocol Questionnaire Response
Example Adverse Medical Event Questionnaire Response | Example of an Adverse Medical Event Questionnaire Response
Example Initiate a Study Questionnaire Response | Example of an Initiate a Study Questionnaire Response
Example Determination Letter Questionnaire Response | Example of a Determination Letter Questionnaire Response
Example Recruitment Materials Questionnaire Response | Example of a Recruitment Materials Questionnaire Response
Example Continuing Review Questionnaire Response | Example of a Continuing Review Questionnaire Response
Example Consent Form Questionnaire Response | Example of a Consent Form Questionnaire Response

### Research Study Example

Example of Research Study | Example of Research Study

### Codesystem Resource

Temporary Codes | This is a temporary codesystem capturing the custom codelists used across the sIRB forms.

### Behavior: Capability Statements

The following artifacts define the specific capabilities that different types of systems are expected to have in order to comply with this implementation guide. Systems conforming to this implementation guide are expected to declare conformance to one or more of the following capability statements.

sIRB Client Capability Statement | This resource describes the required and desired behavior of software clients for use and exchange of the Single Institutional Review Board (sIRB) forms.
sIRB Server Capability Statement | This resource describes the required and desired behavior of FHIR servers for use and exchange of the Single Institutional Review Board (sIRB) forms.