Clinical Trial Confidentiality

A Clinical Trial Confidentiality is a Medical Confidentiality that applies to clinical trial participants regarding the privacy of their personal identity and medical information.

• Context:
  • It usually requires an informed consent for clinical trial researchers to use patient medical records for data verification.
• Example(s):
  • …
• Counter-Example(s):
  • Bank-Client Confidentiality,
  • Clinical Trial Compliance,
  • Commercial Confidentiality,
  • Doctor-Patient Confidentiality.​
• See: Confidentiality Agreement, Privacy Law, Informed Consent, Hippocratic Oath, Good Clinical Practice, Clinical Trial Applicable Regulatory Requirement, Clinical Trial Management System, Clinical Trial Regulatory System.

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References

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-12-4.
  • Confidentiality regarding trial participants
    • Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained. (NLM)
    • Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH E6)

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