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Answer :
Final answer:
In the context of clinical trials, 'Direct Access' is that permission which allows sponsors, through authorized personnel, to examine, analyze, verify, and reproduce any records and reports relevant to the trial.
Explanation:
The subject of this question touches upon the parameters involved in overseeing and managing a clinical trial. Within this context, the term that best matches your definition is c. Direct Access. This typically pertains to a clause in the contract between the sponsor (usually a pharmaceutical company) and the participating investigators (usually doctors/clinics). This clause allows the sponsor, through authorized personnel, to gain access to all documents which support the conduct of the trial and the data generated. This is undertaken to audit the records and verify, for instance, whether the trial is being conducted in accordance with the protocol and the data are being accurately transcribed onto the data collection sheets.
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