Institutional Review Board (IRB) Preliminary Monitoring Form

Institutional Review Board (IRB) Preliminary Monitoring Form

Institutional Review Board (IRB) Preliminary Monitoring Form

Introduction: Routine review is a necessary component of an IRB protocol and contributes toward the shared goal of human subjects research protections. This process is conducted in accordance with Purdue University HRPP Standard Operating Procedure 306, “Post Approval Monitoring”. In order to efficiently collect and process basic information related to the upcoming review an IRB protocol, the designated monitor utilizes this brief standardized form. In-person reviews are conducted between designated post-approval monitoring staff and research personnel to confirm that all measures are documented appropriately in an IRB approved protocol. The designated study monitor will schedule a meeting to discuss the answers to this form and review study documents.

General project information (To be completed by the HRPP Office/Monitor):

IRB Protocol Reference Number:
Title:
Sponsor
Include Grant Number (if known)
Grant Number:
Project End Date (If known)
Original Review Type / ☐ Exempt ☐Expedited ☐Full

Summary of amendments and/or personnel additions:

Amendment Type / Approval Date / Brief Description of Amendment

Personnel Training (those currently listed as active project personnel)

Name / Role on Study / Training Status
Current Not Current Request
Current Not Current Request
Current Not Current Request
Current Not Current Request
Current Not Current Request
Current Not Current Request
Current Not Current Request

Instructions: Utilizing the information in the referenced IRB protocol, answer the following questions and update any outdated statuses. Provide detailed information for any questions answered “Yes”.

Summary of Project Status (To Be Completed by the Principal Investigator or designee)

Proposed Research Rationale and Specific Procedures

Question / Response
  1. Has the scope or purpose of the original project changed since IRB approval?

  1. Were there any changes to the methods of recruitment approved in the original or approved amendments?

  1. What are the current sources of funding for this protocol? Please list all confirmed sponsors and grant titles.

  1. Has your research team encountered any adverse events?

  1. Is recruitment of study participants occurring at a markedly faster or slower rate than originally anticipated?

Personnel

Question / Response
  1. Will you need to add any new personnel or co-PIs to your IRB protocol? Note: New personnel must not participate in collection and analysis of identifiable data until all training is completed and study personnel amendments are approved.

  1. Are there any personnel who have been removed from the project, or will be leaving the project soon?

  1. Are you familiar with the proper procedures to add or remove personnel?

Data Security and Retention / Response
  1. Does your study have an approved consent form or information sheet?

  1. Do you have possession of all signed consent forms for participants enrolled in your study? (For studies where the IRB has waived the need for a participant’s signature, note this in your response).

  1. Are study files kept in a safe location, locked, password protected, and inaccessible to personnel not on the study?

Other

Question / Yes/No (If Yes, Explain)
  1. Do you have other questions to address with Human Research Protection Program or IRB regarding your protocol or the review?

Version 1.0 November 30, 2017

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