My wife is SOCRA (Society of Clinical Research Associates) certified and looking over her shoulder I can state categorically that the clinical observations AT THE TRIAL SITES exist and are discoverable. Amarex, as the CRO for the sponsor (Cytodyn), would have been responsible for site audits to ensure data capture and accuracy was intact by chart review etc. Obviously they failed at this. The trial site participants typically input data through a portal which gets pushed to the CRO who in turn should be looking at data integrity, missing data, etc. Obviously that auditing for study compliance and completeness on the part of Amarex fell short.

Back to the key point however, nearly all study locations in this country are going to have their clinical data in an EMR of which Cerner and Epic are the major players. Whether it is in a physical chart or an EMR it has to be kept, it is part of the patient record and in my opinion definitely discoverable. You will note the Cytodyn language used when they decided to abandon the BLA included various options like conducting a new study, but also the EXPENSE associated with obtaining and processing the data. The inference may be going to the trial sites, getting access to patient data and ensuring that it is all in order. Not cheap…but do-able.