The Trial Master File What is it? - Drug Information Association

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ICH GCP E6 E 6, Ch Chapter t 88: iin TMF after ft th the ttrial i l completes l t From the Sponsor (Vendor): -Clinical Study y report p -Audit certificate -Final close-out monitoring report -Treatment allocation and decoding documentation www.diahome.org From the Investigator: -Final report p to IRB/EC -Completed Subject code list -Final drug accountability documents, and documentation of destruction -Record of retained fluids/tissue samples p ( (during g the trial) )
Anything Missing? Are there any documents missing from the list within the ICH GCP, Chapter 8? Let’s look at these following selected examples of regulations and associated documents… www.diahome.org
Page 1 and 2: The Trial Master File What is it? W
Page 3 and 4: Trial Master File - Definition The
Page 5 and 6: …and and with all applicable regu
Page 7 and 8: Contributors to the TMF • SSponso
Page 9: ICH GCP E6 E 6, Ch Chapter t 88: ii
Page 13 and 14: Ex. of Quality Systems Documents De
Page 15 and 16: Ex. of Electronic System Documents
Page 17 and 18: Ex. of Safety Monitoring Documents
Page 19 and 20: Ex. of an Adequate and Well-Control
Page 21: Thank you for the opportunity to ta

The Trial Master File What is it? - Drug Information Association

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