Clinical Trials Auditing

Observing and evaluating of clinical preliminaries is important to guarantee that the:

  • Rights and security of patients (i.e., human subjects) are ensured 
  • Reported   preliminary  information  are exact, finished, and detailed preliminary information are precise, finished, and evident from source records. 
  • Conduct of preliminary is in consistence with convention, great clinical practice (GCP) and relevant administrative prerequisites. 
  • When leading an IND preliminary, the guidelines require the support to screen the investigation.

Sub Tracks:

  • Informed Consent Process & Documentation
  • Accurate and Complete Study Records
  • Determination and Documentation that eligibility criteria are satisfied
  • Adverse Event review and reporting
  • Closure of study or lapse in approvals while study related activities are still ongoing.
  • Drug/Device accountability
  • Protocol adherence
  • Poor regulatory site documentation
  • Failure to address monitor findings
     

Tags
Clinical Research Conferences 2022 CRO Conferences Clinical Trials Conferences 2022 Clinical Case Reports Conferences Clinical Research Conference 2022 Asia Clinical Research Conference Medical Case Reports Conferences Clinical Research Conference 2022 Japan Oncology Clinical Trials Conferences

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