Essential Clinical Trial Document

An Essential Clinical Trial Document is a document that permits evaluation of the conduct of a clinical trial and the quality of the data produced.

• Example(s):
  • Clinical Trial Case Report Form (CRF),
  • Clinical Trial Audit Report,
  • Informed Consent,
  • Medical Case Report,
  • …
• Counter-Example(s):
  • Do Not Resuscitate (DNR) Order,
  • Informed Refusal.
• See: Clinical Trial Protocol, Good Clinical Practice, Clinical Data Management System, Clinical Direct Access, Clinical Trial Applicable Regulatory Requirement, Clinical Outcome Assessment (COA).

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References

2021

• (Wikepedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#E Retrieved:2021-12-30.
  • QUOTE: Essential Documents
    • Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH E6)

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