Clinical Trial Documentation

A Clinical Trial Documentation is a Document that describes all methods, conduct, and results of a clinical trial.

• Context:
  • It can also contain all patient records.
• Example(s):
  • a Clinical Trial Report.
  • a Clinical Trial Compliance Report (of clinical trial compliance).
  • …
• Counter-Example(s):
  • Electronic Health Record (EHR),
  • Medical Confidentiality Agreement.
• See: Clinical Trial Confidentiality, Applicable Regulatory Requirement, Clinical Trial Participant, Clinical Trial Protocol, Good Clinical Practice, eScreening, eCOA, Med Adherence, Clinical Trial Design, Decentralized Clinical Trial.

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References

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#D Retrieved:2021-12-11.
  • 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. (ICH E6).

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