Direct Access

Direct access (to records and reports) is condition of authorized access to essential trial-related documents, data, and reports by regulatory authorities, sponsors (manufacturers), and designated individuals (e.g. CRAs, auditors). This access facilitates independent assessment of study conduct, integrity, and compliance, ensuring transparency and data accuracy while upholding ethical and regulatory standards.

Definitions

ICH E6(R2)

ICH E6 1.21 Direct Access:

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information.

ICH E6 4.9.7 Records and Reports:

Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records.

ICH E6 5.15.1 Record Access:

The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection.

ICH E6 5.18.4 (k) Monitor's Responsibilities:

Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained .

See also

• Compassionate use - procedure for direct access to investigational products