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Author Topic: Inhouse TMF audit  (Read 2031 times)

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Offline Nisha_r

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Inhouse TMF audit
« on: Fri, 23 Jul 2010 »
Please clear a doubt on  inhouse TMF audit !!!!
For clinical trials what will be the no of inhouse file review ie, project master file and central file( site wise at CRO) by QA.
As there are "n" number of site usually how many inhouse central files will be reviewed by a QA.
Are QA suppose to review all such files or a sampling is been done there?
What will be the frequency of such audits?
How to cover this in a Audit Plan?

Offline Dr.Gunasakaran

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Re: Inhouse TMF audit
« Reply #1 on: Sat, 24 Jul 2010 »
Dear Nisha,

Normally, frequency of QA reviews on central files for different sites of a clinical trial will be SOP driven. Most of the CROs will have QA reviews of all the central files every 3 months or 6 months, which may vary depending on the duration of the study.

Dr.S.Gunasakaran, MD
Head-Clinical Research & Medical Affairs, Azidus Laboratories Ltd, CRO
Disclaimer: All the responses and the postings in this Forum are my personal views and opinion. It does not represent/reflect my company strategies and polices on the same.


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