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.

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.

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.

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.

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.

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.

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.

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.

Example of an Adverse Non-Medical Event Questionnaire Response

Example of a Protocol Questionnaire Response

Example of an Adverse Medical Event Questionnaire Response

Example of an Initiate a Study Questionnaire Response

Example of a Determination Letter Questionnaire Response

Example of a Recruitment Materials Questionnaire Response

Example of a Continuing Review Questionnaire Response

Example of a Consent Form Questionnaire Response

Example of Research Study

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

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

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