Another key component of GCP, Good Clinical Practice, is deviations from the Protocol. Also known as protocol violations. As mentioned before, every single clinical trial has a protocol. The protocol must be strictly followed. Think of it as a recipe. If you’re going to the kitchen and I give you a recipe, you have to follow it exactly as I say, otherwise you’re going to create something else that I did not intend for you to create. It’s very similar with a clinical trial protocol. And you may think, “well this procedure is insignificant” or “this one’s not really important for this so I don’t need to do it”. Those are called Protocol Deviations. Any time you deviate from the protocol, anytime you go off track and you’re doing anything else but strictly adhering to the protocol, this must be reported to the Institutional Review Board, or the IRB as well. Just like an AE or an SAE, protocol deviations must be reported.
5.1 Common protocol deviations
For example, there are many possible protocol deviations. The most common one is that the study participant came to your clinic out of study window.
What this means is usually in the outpatient studies, you have the patient or the study participant is supposed to come in on a schedule, maybe they have to come in every 7 days or every 14 days, whatever the protocol states. They usually give you a plus or minus 2- or 3-day window based on the actual protocol. Sometimes life happens and the study participants can’t come in until 4 days past window. Well this is a protocol deviation. It doesn’t necessarily mean that the study participant can no longer do the study but it is a protocol deviation and therefore must be reported to the IRB on a Protocol Deviation form.
5.2 Deviation report form
Any IRB, if you go to their website will have Protocol Deviation forms. We’re going to get into the forms later such as Site Close Out forms and Continuing Review forms. So, protocol deviation, any time the protocol is not followed for any particular reason, it must be reported to the IRB.
5.3 Intentional protocol deviations
Now sometimes the protocol must be deviated from in order to provide benefit to the study participant. The PI can use his or her best clinical judgment to decide whether they should do that but it still is a protocol deviation and it should be reported as such and we’ll talk more about the different forms and the different IRB forms that you can fill out as per GCP and as per your clinical trial protocol.