If a lab has produced results that were not covered by the protocol, e.g. control enzymes in an assay, that have proved useful and the protocol has subsequently been updated to include these additional biomarkers, can the sponsor go back and retrospectively consent patients in order to obtain the data? Or does the data that was not covered by the protocol/consent initially need to be destroyed?
The idea would be to record/report as a PD, ask EC to approve retrospective consent, consent patients, and include data in analysis as part of the amended protocol...