The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
The Trial Master File What is it? - Drug Information Association
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ICH GCP<br />
E6 E 6, Ch Chapter t 88: iin TMFd TMF during i th the ttrial i l<br />
From the Sponsor (Vendor):<br />
-Updates to any document required<br />
to be present PRIOR to the start the<br />
trial<br />
-Continued Continued HA approval documents<br />
-C of A for new batches of drug<br />
-Mon<strong>it</strong>oring v<strong>is</strong><strong>it</strong> reports<br />
-Relevant R l t communications i ti<br />
-SUSAR communications<br />
-Completed CRFs and CRF<br />
corrections i<br />
www.diahome.org<br />
From the Investigator:<br />
-Signature pages for updated<br />
documents, if applicable<br />
-Continued IRB/EC approval documents<br />
-CVs, CVs etc etc. for new PI and SIs<br />
-Updates to local laboratory documents<br />
-Relevant communications<br />
-Subject logs<br />
-Signature sheet<br />
-Completed CRF and CRF corrections<br />
-<strong>Drug</strong> accountabil<strong>it</strong>y documents<br />
-SAE Documentation
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