When is a Protocol Deviation not a Protocol Deviation? GCP clearly states that all research must be completed as stated in the protocol otherwise it is a deviation and must be reported to the Sponsor and HREC. But what if the site feels they have followed the protocol but the Sponsor disagrees? An ambiguous protocol or one that is open to interpretation does not help anybody.
The easiest way to resolve this is to ask for a formal letter of clarification from the Sponsor . This can be submitted to HREC for approval and filed with the Protocol for future reference. Enter whatever data is available and write an entry into the patient’s Source Documents to explain why the data is missing. You may wish submit a Protocol Deviation to the HREC or include the information in your submission of the “Letter of Clarification”.
If updates to the Informed Consent Form are required as a result of the “Letter of Clarification”, I would not supply the additional information to the Sponsor until the patient has signed the updated consent form. Updating the consent form implies that this is an Amendment to the original protocol as opposed to a clarification and I would treat it as such.