Clinical Trial Audit Trail

A Clinical Trial Audit Trail is an Audit Trail that contains documentation that allows the reconstruction of clinical trial events.

• Context:
  • It can also be a transaction log containing the activities performed by a clinical trial management system.
• Example(s):
  • …
• Counter-Example(s):
  • Clinical Trial Audit Certificate,
  • Clinical Trial Audit Report,
  • Clinical Trial Master File.
• See: Clinical Trial Applicable Regulatory Requirement, Clinical Trial Protocol, Good Clinical Practice (GCP) Guideline, Clinical Trial Information System.

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References

2021a

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-14.
  • QUOTE: Audit trail
    • Documentation that allows reconstruction of the course of events. (ICH E6)

2021b

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Audit_trail#Industry_uses Retrieved:2021-11-19.
  • In telecommunication, the term means a record of both completed and attempted accesses and service, or data forming a logical path linking a sequence of events, used to trace the transactions that have affected the contents of a record.

    In information or communications security, information audit means a chronological record of system activities to enable the reconstruction and examination of the sequence of events and/or changes in an event. Information put away or transmitted in paired structure that might be depended upon in court. An audit trail is a progression of records of computer data about a working framework, an application, or client exercises. Computer frameworks may have a few audit trails each gave to a specific sort of action . Related to proper apparatuses and systems, audit trails can help with distinguishing security infringement, execution issues and application issues. Routine log audits and investigation are valuable for distinguishing security episodes, approach infringement, fake movement, and operational issues soon after they have happened, and for giving information valuable to settling such issues. Audit logs can likewise be valuable for performing forensic investigation, supporting the associations inside examinations, setting up baselines, and distinguishing operational patterns and long run issues.

    In nursing research, it refers to the act of maintaining a running log or journal of decisions relating to a research project, thus making clear the steps taken and changes made to the original protocol.

    In accounting, it refers to documentation of detailed transactions supporting summary ledger entries. This documentation may be on paper or on electronic records.

    In online proofing, it pertains to the version history of a piece of artwork, design, photograph, video, or web design proof in a project.

    In clinical research, server based systems such as clinical trial management systems (CTMS) require audit trails. Anything regulatory or QA/QC related also requires audit trails.

    In voting, a voter-verified paper audit trail is a method of providing feedback to voters using a ballotless voting system.

2018

• (FDA, 2018) ⇒ FDA (2018). "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry".
  • QUOTE: 1.9 Audit Trail'
    • Documentation that allows reconstruction of the course of events.

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