Clinical Direct Access

A Clinical Direct Access is an Informed Consent that gives a clinical trial researchers and clinicians the permission to examine, analyze, verify, and reproduce any patient records that are important to evaluation of a clinical trial.

• Context:
  • It is usually constrained by applicable regulatory requirement and clinical trial confidentiality.
• Example(s):
  • …
• Counter-Example(s):
  • Direct Patient Care,
  • eConsent.
• See: Medical Ethics, Medical Law, Conflict-of-Interest, Therapy, Clinical Research, Clinical Trial Participant, Clinical Trial, Controlled Clinical Trial, Research Ethics, 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.
  • Direct Access
    • Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors, monitors, and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. (ICH E6)

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