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Thread: Study documents relating to quality issues filed in the TMF

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  1. #1
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    Study documents relating to quality issues filed in the TMF

    Please can you let me know any recommendation/view points on study documents in the TMF relating to quality issues. In my experience, these document types are mostly contained within internal quality systems, but more and more their are several opinions on what constitutes evidence of the TMF story, plus the evolving landscape of what Inspectors want to see. Examples of documents related in this area that I am looking for consensus on and some are interchangeable terminology wise are: non-conformity documents (investigation and outcome), quality issues (investigation and outcome), documents relating to assessing serious breaches (investigation, meetings and outcome), CAPAs, site quality correction plans, etc,.

    Any input would be welcome.

  2. #2
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    Hello - I'm no expert, but I'd expect all of the cited examples to be maintained in the TMF.

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