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Guidance Protocol Deviations & Violations

By Wayne Bradley,2014-04-22 20:15
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Guidance Protocol Deviations & Violations

    Guidance Protocol Deviations & Violations

    DEVIATIONS are any variance in the approved study protocol, criteria or procedure that does not affect the participant’s safety, rights, welfare or the integrity of the study and its resultant data. An example of this would be a participant visit conducted outside of the visit window.

    VIOLATIONS to the protocol are deviations that increase the risk or decrease the benefit and/or affect the participant’s rights, safety, welfare and/or integrity of the

    resultant data.

    1. Deviation reports are usually forwarded to the IRB at the time of continuing review. The deviation report sent to the IRB should include:

     - A memo addressed to the Committee on Human Rights Research

     (Deviation & Violation IRB memo.doc)

     - A Protocol Deviation & Violation Log

    For investigator initiated studies, the Principal Investigator will keep an

    internal protocol deviation and violation log that will be forwarded to the

    IRB at the time of continuing review.

    For industry sponsored studies the sponsor may keep a patient specific

    deviation and violation log with each case report form. These will be

    forwarded to the IRB at the time of continuing review. For industry

    sponsored studies that do not have a study-specific deviation log, an in-

    house deviation and violation log should be used.

    Any monitoring letters outlining deviations should be forwarded to the IRB.

    If a response to the monitoring letter is issued, both the initial letter and

    the response will be forwarded to the IRB.

    Most protocol deviations are reported to the IRB on an annual basis, but

    those that involve physical assessments, labs, drug dosing, dispensing,

    etc., are considered violations and pose a possible risk to patient safety by

    the IRB, and need to be reported ASAP.

2. Violation reports should be reported to the IRB within five business days of

    investigator notification, or as soon as study personnel are aware of the violation.

This submission to the IRB should include:

     - A memo addressed to the Committee on Human Rights in Research

     (Protocol Violation Report Memo).

     - A Protocol Violations Report

     - A Corrective Action Plan outlining what safeguards/steps the Principal

    Investigator has put in place, or taken, to prevent the violation from

    occurring again.

    This document is meant to aide in the process of conducting a clinical trial and its usage is not required, for it is not part of the formal procedure conducted at WCMC. 1 of 2

    A Protocol Violations Report should include the following information

    (template available):

    ; A description of the protocol violation.

    ; Notations of any compromise to patient’s safety, or documentation that

    there were no safety issues.

    ; Documentation of the contact with the sponsor regarding the situation and

    outcome.

    ; A description of the action plan in response to the event.

    If a protocol violation does involve a compromise to patient safety, please inform the Principal Investigator and the Clinical Trials Administrator (if applicable) as soon as possible.

    Principal Investigators are required to report all deviations and violations in this manner regardless of protocol type, or sponsor.

    If a study sponsor has already provided you with a similar protocol violation log, continue to use the sponsor’s log and disregard this one.

    HOWEVER, if the sponsor has not provided you with a protocol violation log, and you are only capturing this information in primary source documents, please

    create a log, or use our template.

The following templates are available for your study binder:

    ; Protocol Deviation and Violation Log

    ; Protocol and Deviation Log Memo

    ; Protocol Violation Report

    ; Violation Report Memo

This document is meant to aide in the process of conducting a clinical trial and its usage is not required, for it is not part of the formal procedure conducted at WCMC. 2 of 2

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