Uniformed Services University

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:

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.
Category	Document	Comments	Reason
Administrative	USUHS Form 3208 (for faculty) and Form 3202 (for students)		Linkage with USUHS VPR tracking system
Administrative	Summary of Grant Application	If applicable	Is protocol aligned with goals of funded project?
Administrative	Verification of Scientific Review	Documentation of who, when, where, outcome, if applicable. No member of the study team can be a member of the scientific review board or process	IRB will only review protocols that have undergone competent scientific review
Administrative	Command Authorizations	If applicable. Local site Human Subject Protection Administrators have done a pre-review and sent an acknowledgment letter	Assure that authorization is prospective
Study Team	Conflict of Interest Statement		Assure quality and integrity of study team
Study Team	Researcher Responsibility Statement		Assure quality and integrity of study team
Study Team	Verification of relevant CITI Training for all members of Study Team		Assure quality and integrity of study team
Study Team	Curriculum Vitae current within the past two years for members of Study Team, relevant licenses that are current	Include 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 Vitae	Assure quality and integrity of study team
Protocol	Protocol		Primary review document
Protocol	Sample Informed Consent Form		Primary review document
Protocol	Data Collection Forms, survey instruments, questionnaires		Primary review document
Protocol	Recruitment and Advertising material		Primary Review Document
Protocol	HIPAA Waiver of Authorization	If applicable	Data custody and privacy
Agreements	Copy of MOUs and Partnership Agreements	If applicable	Data custody and privacy
Agreements	Data Sharing Agreements	If applicable	Data custody and privacy
Agreements	Material Transfer Agreements	If applicable. Agreements are usually in draft form and not executed until the study has IRB approval	Reagent, resources, and sample custody and responsibilities
Agreements	Statement of Work	If applicable
Agreements	Memoranda of Understanding	If applicable	Supporting document
Agreements	Individual Investigator Agreement	If applicable	Supporting document
Agreements	Letters of Support	If applicable	Supporting document
Product Safety	Investigator’s Brochure	If applicable	Supporting document
Product Safety	Approved Product Package Insert	If applicable	Supporting document
Product Safety	Food and Drug Administration IND or IDE number	If applicable	Supporting document

About USU

Academics

Research At USU

Centers

Military At USU

AFRRI At USU

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

Human Research Protections Program Office (HRPPO)

Pre-review Administrative Checklist

Table 3