direct access

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direct access

Permission to examine, analyse, verify and reproduce any records and reports critical in evaluating a clinical trial of a drug product or intervention. Parties (e.g., domestic and foreign regulatory authorities), a sponsor's monitors and auditors with direct access must take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and the sponsor's proprietary information.

direct access

Managed care adjective Referring to a Pt's ability to be treated by a specific provider without gatekeeper approval. See Gatekeeper.
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