Significant protocol deviations that occur in CRC studies are to be reported to the RSA office as soon as possible using the form that can be downloaded below. Significant protocol deviations are those that involve consent form issues or those that affect the safety of subjects or the integrity of the study data. Corrective actions must also be described which include measures taken to ensure that similar deviations do not occur in the future. If you have any questions, please call Nancy Needler at 275-1020.

Examples

• The subject dates the consent form incorrectly, and the error is not noticed at a time when the subject can make the correction.
• The wrong consent form is used (i.e. the most recent approved version of the consent was not given to the subject).
• Lab tests for safety to be done at each study visit were not done as indicated in the protocol.
• A subject did not take medication or took prohibited medication during a study.
• A subject was included in a study even though the inclusion/exclusion criteria was not met.

To download form in Microsoft Word click on the link below

ProtocolDeviationReportForm030906