Wednesday, December 8, 2010

A clinical trial inspection - general procedure

  • Review of the procedures, frequency, scope and process of the sponsor / CRO used to monitor progress
  • Reviewing SOPs and Monitoring Plans, interview personnel, and read trip reports
  • Review of items to determine that the clinical study / investigation was conducted in accordance with the signed protocol that was submitted to the FDA
  • An assessment of protocol deviations or violations from the approved protocol or FDA regulations and how the sponsor / CRO handled them
  • An Assessment of training records, SAE reporting, drug accountability,
  • Particular attention to both non-compliant sites and the highest enrollers
  • Inconsistencies such as protocol deviations, source documents not mirroring CRFs, unclear informed consents, confused Pis
  • Is the PI in compliance with the FDA Form 1572
  • Making sure the IC process was clear sans coercion
  • Do all subjects meet all Inclusion / exclusion criteriaIs the data reasonable and fits the sourse data
  • Are all IRB/IEC approvals reasonable / appropriate

to Know more attend the training

GCP violations and Site Mistakes commonly found During a FDA Investigator Site Inspection/Audit

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