If there is an unapproved change, a violation to the conduct of the protocol, or deviation from the written protocol, a protocol deviation report must be submitted to the CPHS via iRIS no later than 10 business days from when the investigator learned of the deviation. This can be found under Submission Forms in iRIS. The protocol deviation report is sent to the CPHS Chair only if there is a serious consequence to the deviation or violation. The Chair decides if any further action is warranted, and, together with the subcommittee or full committee and the investigator, decide on a plan to prevent any protocol deviations in the future. It will also be decided if the PI and research team need to undergo further education on the conduct of research with human subjects.
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