Inspections and Pre Inspections

The act by a regulatory authority of conducting an official review of documents, facilities and any other resources that are deemed to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s or CRO facilities or at other establishment deemed appropriate by the regulatory authority. 

A) Purpose: The rights and well being of the trial subjects are well protected The trial data credible, complete and verifiable from the source documents The conduct of the trial is in compliance with the current approved protocol/amendments and GCP and the regulatory requirement

B) Types: Routine: Inspections assigned for NDA’s Directed: Problems identified at
IND stage, complaints to DSIPre Approval Clinical Investigator Inspection Sponsor/CRO/Monitor Inspection  

C) Process: Scheduling of Inspection Site selection Inspection review of sponsor files Inspector arrives and presents credentials and FDA-482Opening meeting Review of study conduct Request copies of documents and/or samples Discussion with the Investigator and site staff Presents the deficiencies and corrective actions Written report sent to Sponsor/Investigator 483 and follow up inspections

D) Criteria for selection: Insufficient domestic data Only foreign data submitted to support an application Conflicting data between domestic and foreign data Serious issues: Suspecting fraud, scientific/ethical misconduct, human subject protection violation      

E) Review: Trial related documentation Interview with clinical trial staff Facility tour Review records and record keeping Source data verification Review of other resources related to the trial Site to be prepared for:FDA form 1572IRB communication Informed consent Process SAE notification Patient logs Medication dispensing logs Inclusion/Exclusion criteria issues       Source document issues role in the study

F) Inspection Outcomes:

NAI: No action indicated Firm in compliance No actions/ response necessary: Voluntary action indicated Violative practices noted requires corrective actions Responses required and follow up inspection expected OAI: Official action indicates Violation are severe enough to warrant immediate administration actions , Reinspection likely Warning letter 

G) Common findings at Inspections Record keeping deficiencies (34%)Protocol deviations (25%)Test article accountability (5%)Adverse event reporting (2%)Informed consent (2%)

This entry was posted on 13. December 2009 at 14:31 and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response or trackback from your own site.

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