Documentation

Documentation (as records) is organized and systematic records that encompasses various aspects of a study, including protocols, informed consent, patient data, and regulatory submissions. These documents ensure the traceability and transparency of research activities, demonstrating compliance with ethical and regulatory standards. Effective record-keeping is vital for maintaining data integrity, research accountability, and the ability to verify study procedures and findings.

Definitions

ICH E6(R2)

ICH E6 1.22 Documentation:

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken .