Study Information

Study Overview

Study Title

IRBNet#

PI Name

PI Type

Faculty Sponsor

Review Type

College/Department

Type of Study

Co-Investigator

Collaborative Research

Is DUA agreement on file?

Total Enrolled To Date

Total Approved for Enrollment

Monitoring Information

Date Monitored

Monitor

Records and Data Management

What is the storage location listed in IRBNet?

Where are the study records physically stored?

Where are the consent forms stored?

Do file cabinets have locks?

Are computers password protected?

Are consent documents stored in an orderly fashion?

Additional Comments & Explanations

Subject Recruitment Procedures

How are potential subjects identified?

Describe recruitment methods stated in the IRB approved protocol

If recruitment materials are used, specify: (check all that apply) Advertisements (posted) Flyers Web posting Letters

Is the process for subject recruitment and identification consistent with IRB application and IRB policies?

According to IRBNet, how will data be recorded to protect privacy?

Is the research team following this method?

Additional Comments & Explanations

Informed Consent Process

How many versions* of the consent form are there?

Consent Version Date

Have subjects been enrolled?

Were any invalid consent forms used?

Did anyone not approved by the IRB to consent subjects sign as study representative?

If yes, was a violation report submitted to the IRB?

Does the IRBNet application indicate the inclusion of minors? If yes, was parental permission obtained?

Was child assent obtained?

Was parental permission waived?

Additional Comments & Explanation

Subject Selection Criteria

Is there an eligibility checklist containing inclusion/exclusion criteria?

Does each subject file indicate whether the subject was included/excluded appropriately?

If any subjects that did not meet eligibility criteria were enrolled, was a protocol violation submitted to the IRB?

Additional Comments & Explanation

Source Documentation

CITI Training Records (Electronic or Hard Copy)

Completed data collection measures (surveys, questionnaires, etc.)

All notes and/or files of observations recorded

Adverse events, protocol deviations, etc.

Additional Comments & Explanations

Adverse Events, Unanticipated Problems, Protocol Deviations

Is there documentation of Adverse Event(s)?

Was this reported in IRBNet?

Is there documentation of Unanticipated Problem(s)?

Was this reported in IRBNet?

Is there documentation of Protocol Deviations?

Was this reported in IRBNet?

Description of all adverse events, unanticipated problems, and protocol deviations

Please describe all adverse events, unanticipated problems, and protocol deviations

Study File Review

Protocol (current and all prior versions)

Consent form (current/approved and all previously approved)

Any written material (other than consent form) distributed to subjects

Applications and reports submitted to the IRB

Correspondence between the PI and IRB

IRB approval notices

Copies of all adverse events reported to the sponsor and IRB

Correspondence between PI and study sponsor

Sponsor monitoring log and corresponding reports

Investigators’ CVs

Participant screening log

Participant enrollment log

Other

IRB Documentation

Is this protocol a full board review or expedited review requiring board oversight and continuing review?
What is the expiration date?

Number of continuing reviews, to date?

Indicate continuing reviews on file (date submitted, date approved, IRB letter on file [Y/N])

Was each continuing review submitted on time?

Was there any lapsed period(s) between expiration date and continuing review approval date?

Were any subjects enrolled during this lapse period?

Were any study procedures done during this lapse period?

Were they approved by the IRB?

Was this an expedited review with "Next Review Date?"

When is next review due?

Comments, Recommendations, and Follow-Up Items

Include a general review of findings, including any recommendations and requirements.

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.