15th Nov 2016, 09:31 AM
GCP issue for sponsor approval before randomization
We are running a phase 3 MRCT trial, to ensure a better compliance to study inclusion criteria, the sponsor required that for every patient that are to be enrolled, there is an "eligibility verification procedure" by sponsor's medical monitor, and this will be done through EDC data review and may have some query emails. Only after the approval of the sponsor, the investigator could proceed to randomize the trial subjects.
This procedure has been challenged by some investigators, viewing as an interference of their medical judgment and some of them will not agree to do so. The investigator thinks the sponsor's medical monitor could only advise on trial related medical questions but not make decision for them, this procedure could possibly violate GCP. However, in that case, the sponsor is asking to document as "major PD".
We searched carefully of guidance and GCP guidelines, but still could not find an ideal solution: who is correct on this? This procedure was designed with protocol compliance intention, but could it violate GCP?
29th Nov 2016, 12:25 PM
Interesting question. How would this differ from IRT (interactive response technologies) and IWRS (interactive web-based response systems) control of access to Investigational Medicinal Product via electronic compliance with certain data entered into the system? This would control dispensing of IMP to only those who were eligible for the trial. The MHRA 2012 GCP Guide has lots of information on this. Section 188.8.131.52 is particularly useful. This includes data on eligibility being sent to a "central data centre" in order for the investigator to be provided with randomisation codes etc.