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Instructions for New Revision & Deviation/Exception Forms

This document provides instructions for completing revision and deviation/exception forms for research protocols, including details on revision types and risk and benefit classification.

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Instructions for New Revision & Deviation/Exception Forms

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  1. Instructions for New Revision & Deviation/Exception Forms

  2. RevisionsSections 1 and 2 1. Revision description (check all that apply): Revision to currently approved protocol (e.g. changes to purpose, procedures, subject population, etc) Revision to currently approved consent form(s) (complete item 4) Revision to personnel (include a copy of the updated personnel list) Other (e.g. Advertisement, patient information, Investigator Brochure) (For advertisements: specify how the ad/brochure will be distributed and include a letter of cooperation from any private location other than public bulletin boards/posters or paid ads. Follow hospital/departmental guidelines for posting within Lifespan) NEW Wording 2. Risk and Benefit classification of requested revision: a. Does this revision increase risks to participants enrolled in the study  yes  no If yes, include explanation how risk has increased and what has been done to minimize risk . b. Does this revision affect benefits to subjects or others?  yes  no If yes, explain:

  3. RevisionsSection 3 New Wording • Specifically describe how the proposed revision will alter the currently approved project.( NOTE: “see attached” is not acceptable. When the signed revision request is returned to you no attachments will be included. Therefore, without an explanation on this form you will have no information to document your reason for submission). • Explain the purpose or rationale for this protocol amendment? • If difficulties been experienced in the conduct of the approved protocol that have prompted this change, explain what has been learned and what will be done to alleviate future problems. • Explain how the revised protocol will differ from the approved project.

  4. RevisionsSections 4 & 5 (No Change) • Did you attach revised protocol and/or consent/materials  yes  no  N/A (If change to consent attach 1 copy of consent with changes highlighted and 1 clean copy for approval stamp; if changes to personnel, attach a revised personnel list, if changes to other documents, ads, brochures, protocol, etc., attach document with highlighted changes requested and clean copy) 5. Does this change require notification of currently enrolled subjects?  yes  no If YES, then describe how subjects will be notified.

  5. Deviation/Exception Report Date of Deviation/Exception: _____________ New Wording - Type: (check all that apply and briefly explaineach deviation/exception. Submit supporting documents if available and applicable).  Enrollment  Visit Schedule  Entry Criteria  Missed labs/exams/procedures  Other Provide an explanation of the circumstances and resolution of this deviation/exception New - (“see attached” is not acceptable. When the signed deviation report is returned to you no attachments will be included. Therefore, without an explanation on this form you will have no information to document your reason for submission).

  6. Deviation/Exception Report Sponsor notification:  yes  no New - Sponsor Granted Exception:  yes  no Name of Sponsor: ______________ New - Describe what measures have been put into place to prevent future recurrences (if applicable):

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