Should we create a protocol deviation for an unscheduled visit?

Question:

Question edited from the original:  In case of an unscheduled visit, or a Serious Adverse Event that occurred and was treated outside the study site, should a protocol deviation be created if not all tests are done per protocol?

- Clinical team, large biopharma company

Response: 

The determination of what should be considered a protocol deviation (or “violation”, or “minor”/”major” deviation, etc., depending on the policy being followed) is usually based on a policy or SOP from the study sponsor, or sometimes from the study site. Tracking protocol deviations can be useful for explaining missing or out-of-window data, for identifying parts of the protocol that are difficult and may need revision, for identifying instances of non-compliance of study site teams that need to be addressed, and for identifying events that may require prompt reporting to the IRB.

Some protocols define procedures to be completed if the participant must have an unscheduled study visit- perhaps for the assessment or treatment of an adverse event during the study.  If the protocol does define procedures for that type of visit, and the procedures were not completed, that seems like it would meet the definition of a protocol deviation, although the applicable policy should be consulted. 

However, if an adverse event/serious adverse event occurs and the participant is seen and treated at a facility that is not participating in the clinical study, the providers there will presumably perform clinically-appropriate testing.  They may not complete every test that is defined in the protocol to be completed at a scheduled or unscheduled study visit.  But they are not a study site, and they don’t have the protocol to follow. So it doesn’t seem to be useful or productive to document that there was a “deviation from the protocol” when the providers didn’t have a protocol to follow.

About the Author

Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG

Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.

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