Protocol deviations occurring during study conduct can represent a change in study design and therefore must be promptly reported to Goodwyn IRB. When a significant deviation occurs, complete the deviation report and forward it with any associated documentation to Goodwyn IRB.

Please note the following definitions:

Protocol Deviation: Any change in the conduct of a research study not recorded in an approved protocol or amendment.

Significant Protocol Deviation: Any change in the conduct of a research study that significantly affects the safety of the subjects or the scientific quality of the study. For instance:

• Enrollment of patients that do not meet the eligibility criteria for the trial
  
•  Study procedures - in particular procedures in place to monitor safety - are not performed or significantly delayed.
  
•  Failure to obtain informed consent prior to conducting any study procedure.
  
•  Failure to administer and/or account for study drug as described in the protocol.

Deviation Report Form *   **

* The DOC file format requires that you have Microsoft Word '97 or higher installed on your computer. If you do not, please use PDF format.
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