Generic checklist for IRB analyst initial administrative pre-review of EIRB submissions

Pre-review Administrative Checklist

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:

IRB Process Schematic

 

 

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.

Table 3

The internal checklist for initial administrative pre-review follows.
CategoryDocumentCommentsReason
AdministrativeUSUHS Form 3208 (for faculty) and Form 3202 (for students)Linkage with USUHS VPR tracking system
AdministrativeSummary of Grant ApplicationIf applicableIs protocol aligned with goals of funded project?
AdministrativeVerification of Scientific ReviewDocumentation of who, when, where, outcome, if applicable. No member of the study team can be a member of the scientific review board or processIRB will only review protocols that have undergone competent scientific review
AdministrativeCommand AuthorizationsIf applicable. Local site Human Subject Protection Administrators have done a pre-review and sent an acknowledgment letterAssure that authorization is prospective
Study TeamConflict of Interest StatementAssure quality and integrity of study team
Study TeamResearcher Responsibility StatementAssure quality and integrity of study team
Study TeamVerification of relevant CITI Training for all members of Study TeamAssure quality and integrity of study team
Study TeamCurriculum Vitae current within the past two years for members of Study Team, relevant licenses that are currentInclude state of each individual’s role on the study, location, contact information, and responsibilities. Research medical monitors require conflict of interest statement, medical license, researcher responsibility form, documentation of human subject research training and a Curriculum VitaeAssure quality and integrity of study team
ProtocolProtocolPrimary review document
ProtocolSample Informed Consent FormPrimary review document
ProtocolData Collection Forms, survey instruments, questionnairesPrimary review document
ProtocolRecruitment and Advertising materialPrimary Review Document
ProtocolHIPAA Waiver of AuthorizationIf applicableData custody and privacy
AgreementsCopy of MOUs and Partnership AgreementsIf applicableData custody and privacy
AgreementsData Sharing AgreementsIf applicableData custody and privacy
AgreementsMaterial Transfer AgreementsIf applicable. Agreements are usually in draft form and not executed until the study has IRB approvalReagent, resources, and sample custody and responsibilities
AgreementsStatement of WorkIf applicable
AgreementsMemoranda of UnderstandingIf applicableSupporting document
AgreementsIndividual Investigator AgreementIf applicableSupporting document
AgreementsLetters of SupportIf applicableSupporting document
Product SafetyInvestigator’s BrochureIf applicableSupporting document
Product SafetyApproved Product Package InsertIf applicableSupporting document
Product SafetyFood and Drug Administration IND or IDE numberIf applicableSupporting document