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 TMF after ft th the ttrial i l completes l t<br />
From the Sponsor (Vendor):<br />
-Clinical Study y report p<br />
-Aud<strong>it</strong> certificate<br />
-Final close-out mon<strong>it</strong>oring report<br />
-Treatment allocation and decoding<br />
documentation<br />
www.diahome.org<br />
From the Investigator:<br />
-Final report p to IRB/EC<br />
-Completed Subject code l<strong>is</strong>t<br />
-Final drug accountabil<strong>it</strong>y<br />
documents, and documentation of<br />
destruction<br />
-Record of retained fluids/t<strong>is</strong>sue<br />
samples p ( (during g the trial) )
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