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

## Additional Implementation Requirements and Considerations

The Capability Statement does not capture all of the requirements for sIRB IG compliance. This page explains other requirements necessary to meet conformance expectations. It also discusses optional capabilities which could be implemented depending on the use case.

The sIRB IG assumes that the implementer is familiar with the SDC Specification.

### Questionnaire and QuestionnaireResponse resources

#### Questionnaire and QuestionnaireResponse Expectations

- To be compliant with this IG, a system SHALL render the eight sIRB Questionnaires for completion, transmit the completed QuestionnaireResponses between the relying site(s) and the host (lead principal investigator’s institution) and submit the completed QuestionnaireResponse for storage at the host(lead principal investigator’s institution).

- To be compliant with this IG, a system SHALL allow editing of the completed QuestionnaireResponse and display the completed QuestionnaireResponse for review or saving to pdf.

  #### Extensions for the Questionnaire and QuestionnaireResponse

The following extensions are used in the sIRB Questionnaires in order to make the Questionnaires display and function as described in the examples, as tested by prospective users and as shown in the forms rendered by the Questionnaire Viewer:
choiceOrientation
displayCategory
hidden
itemControl
supportLink
unitOption
variable
rendering-style
rendering-xhtml
For more information about Questionnaire extensions, please see the SDC Implementation Guide Extension definitions and SDC Implementation Guide Examples.
Style decisions, color choices and orientation of the questions and/or answers were developed using feedback from prospective users. If the forms are integrated into other research study systems, harmonization of the appearance of the forms with the design of the research study system will not result in non-compliance with the IG.
If an implementer chooses to use the optional ResearchStudy resource, the workflow-researchStudy MAY optionally be used on the QuestionnaireResponses to capture that the QuestionnaireResponses are relevant to the specified research study(ies). The official URL for the workflow-researchStudy is http://hl7.org/fhir/StructureDefinition/workflow-researchStudy.

### Expectations for Questionnaire Population

The sIRB Questionnaires are populatable. The sIRB forms are designed with one master form, the Initiate a Study questionnaire, that collects common data elements which will then be populatable into the other sIRB forms so that researchers do not need to re-type the same information into multiple forms. Entering common data elements only once (via the Initiate a Study questionnaire) saves time for the researchers and study coordinators while reducing data entry errors.
Implementation assumes that the implementers will be knowledgeable about SDC Form Population.

- The following SDC extensions are used in the Questionnaires to make the populate functionality work as described:

Extension
Answer Expression
Initial Expression
Calculated Expression
Launch Context
variable

Some guidance is provided here:

- The client software can be designed to function similar to the population operations described in the SDC IG, but as a client-side process, rather than calling the FHIR server population operations.
- The sIRB Questionnaires use Expression-Based Population.
- The Questionnaires also utilize answerExpression functionality from the Form Behavior and Calculation section of the SDC IG in order to populate the drop-down list of permitted answers for some of the questions.
- For more information on Expressions, also see Expression Extensions.
- fhirpath is used in the Answer Expression(s), Initial Expression(s), Calculated Expression(s) and Launch Context Expression(s) used in the Questionnaires. An implementation of fhirpath will need to be included with the software client for the sIRB forms.

### Other implementation recommendations

The REST FHIR Questionnaire Management Software (client software) will need to perform activities such as:

- Retrieving Questionnaires from the repository

- Displaying Questionnaires

- Populating Questionnaires

- Validating completed forms and submitting to the FHIR server for exchange and/or storage

- Retrieving Questionnaire Responses for edit and display

- Extracting data from the Initiate a Study Questionnaire Response to create and update the ResearchStudy resource (if the optional ResearchStudy resource is being used)

- Creating the workflow-researchStudy extension (if the optional workflow-researchStudy extension is being used)

- Creating the optional Provenance resource and providing the data for the elements of the resource
  It is beyond the scope of this IG to provide detailed instructions on how to implement these functions, especially because the client 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.

  ### RESTFUL interactions

The RESTful API page of the FHIR specification provides detailed directions on usage of RESTful FHIR. Please consult the General Considerations section if there are questions about the meaning of any components in the interaction definitions.
Some of the http commands that implementers may find useful for the exchange of resources are listed below:

- A Questionnaire can be retrieved using search by url

      GET [base]/Questionnaire?url=[url]

- A QuestionnaireResponse can be retrieved either by read or search by _id

      GET [base]/QuestionnaireResponse/[id]

  or

      GET [base]/QuestionnaireResponse?_id=[id]

- The vread interaction can help the implementer retrieve a specific version of a QuestionnaireResponse. This will support the use case in which a researcher decides to revert back to a previous version of a form when a study’s forms have been prepared in multiple iterations before final approval. For instance, a researcher may initially prepare the forms as a solo lead principal investigator then subsequently have interest from a co-investigator. A new version of the forms may be prepared using input from the co-investigator, also listing the co-investigator’s contact information throughout the forms. If the prospective co-investigator later decides not to participate in conducting the study, then the original researcher would want to revert back to the original forms instead of editing the latest versions to remove all of the input and references to the co-investigator who will now not be involved in the study.

      GET [base]/QuestionnaireResponse/[id]/_history/[vid]

- As discussed at https://www.hl7.org/fhir/questionnaireresponse.html#scope, QuestionnaireResponses are often retrieved with the cooresponding Questionnaire in order to display the questions, allow for editing of the answers or to validate answers against the Questionnaire definitions. The Questionnaire can be included when retrieving the QuestionnaireResponses as follows:

      GET [base]/QuestionnaireResponse?_id=[id]&_include=QuestionnaireResponse:questionnaire

- If the QuestionnaireResponse _id is unknown, the Questionnaire to which the QuestionnaireResponse applies can be used as a search parameter:

      GET [base]/QuestionnaireResponse?questionnaire=[questionnaire]&_include=QuestionnaireResponse:questionnaire

- A search can return all of the QuestionnaireResponses for a specified Questionnaire limited to a given status:

      GET [base]/QuestionnaireResponse?questionnaire=[questionnaire]&status=[status]&_include=QuestionnaireResponse:questionnaire

- A completed form can be sent to the FHIR server using POST:

      POST [base]/QuestionnaireResponse

- If the optional ResearchStudy resource and/or the Provenance resource(s) are part of the implementation, they can be created using POST also:

      POST [base]/ResearchStudy

  and/or

      POST [base]/Provenance

- The update interaction is used to send an updated/edited QuestionnaireResponse to the FHIR server:

      PUT [base]/QuestionnaireResponse/[id]

  The sIRB IG allows for the patch interaction, if implementers wish to use patch to only update a portion of a resource. This was primarily designed to allow partial updates in the event of very large protocol forms with many attachments, which could slow down the update interaction. The use of the patch interaction is entirely optional and is not expected to be widely implemented. If used, the patch interaction uses the content type of application/json-patch+json.

  ### Search Parameters

  The sIRB Server Capability Statement and the sIRB Client Capability Statement identify search parameters relevant to sIRB implementers. In the event that the data from the completed forms will be persisted outside of the FHIR server, many of the search functions listed in the sIRB Server Capability Statement and the sIRB Client Capability Statement could foreseeably be handled by another system. Hence, many of the search parameters in the sirb Capability Statements are listed as “MAY” because some implementations will handle data searching in another system.