Regulatory Red Flags: Non-Finalized GLP studies:
Did you ever wondered how to manage a non-finalized GLP study? What if the sponsor’s attention went away from its actual GLP investigation? Maybe the results were not mandatory anymore or other reasons were associated with its loss of interest.
From a regulatory point of view, GLP data cannot be cancelled for any reason:
once collected, they are part of the study.
Raw data should be archived as per GLP practices.
There are several ways how to handle such uncomfortable situation. also, few tips & tricks to avoid difficult regulatory discussions.
The normal procedure is to ask the Sponsor if any further work is needed. if the sponsor confirms as no further work is needed, a Draft report should be issued followed by Final Report.
However, in some cases responses are still lacking from Sponsors.
In general, SOP’s should already be in place describing the procedures that will Need to be followed in case of non response.
the SOP should mention that if the sponsor does not reply to the draft within e.g. 6 months, a final report will be issued and sent to the sponsor.
By this way, you will not be perceived as chaotic or even be hold responsible by the regulatory authority of hiding GLP-driven study results.
In addition to your relevant SOP that should clearly define - finalization due to no response from the sponsor - make sure to keep adequate documentation showing you tried to contact the sponsor.
