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 [1].
See also
Links to this page
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf