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.

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