What follows is referred to as a pre-review by an IRB analyst so that when either an Exemption Determinations Official, the IRB Chair, or the full IRB review a document they have all the essential information organized in a consistent manner.
The pre-review has two stages- an initial administrative review to determine if all the required documentation and related information is present and then a content review to determine if the submitted information is complete and consistent. If during the administrative review documents or information are missing, the IRB analyst will contact the study team to provide what is missing. If during the content review the IRB analyst finds inconsistent or missing or ambiguous information, he or she will contact the study team for clarification.
A schematic of the process is:
The internal checklist for initial administrative pre-review follows in Table 3.
If any of the documents or information, listed in Table 3, are considered necessary to perform a content review by the Analyst in preparation for the formal review by the IRB and are missing from the application, then the submission is returned so that the study team can provide the appropriate documentation to the EIRB system to complete the submission. An incomplete submission cannot be properly reviewed by the IRB analyst nor by the subsequent peer review.
