Hi
I feel the following points can be covered in the audit report!

• A summary of the audit
  Audit Conclusion
  List of Audit Observation which are categorized under critical, Major or    Minor
  Recommended corrective and preventive action
  List of personnel present during the audit including their names, affiliation and role in the study
  Records reviewed during the audit

The audit report can be sent to the site or can be sent as a follow up report. But should ensure that audit report is not filed in any study file and can tell the site to destroy after the corrective action taken fo the same

Correct me if am wrong

Dear member,

In addition to this my question is once the findings are submitted to the Site, is there a second visit by d Auditor to check the compliance to the deviations?

Thank you

Forum

Hi,

The answer to your doubt is a no and a yes. There could be an audit (by another auditor / inspection from a regulator) or may not. It is however, not a mandate that an auditor revisits the site to ensure the compliance.

My views in this aspect, is that Quality consciousness should be in every stakeholder's mind. Quality is not the only property of a Quality Assurance personnel / an auditor. QA check is a preventive check to take measures on those aspects of quality that compromises on the credibility on the data generated, reported and analysed in a clinical trial. It addresses the system / process level problems that needs to be addressed, because it involves sampling.

It is the responsibility of the study team members to ensure the resolution of reported problems and preventive it from recurring in future. Hope this helps.

Regards
Sushma