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
     

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