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

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What about for Proof of an Adequate and Well-Controlled Trial? Regulation/Guidance reference: Included Documentation: 21 CRF 314.26 Adequate measures described in the Blinding plan, taken to minimize bias on the part of subjects, observers, and analysts of the data. Method of assigning patients to treatment and control t l groups ddescribed ib d iin th the Randomization plan, to minimize bias, and is intended to assure comparability of the groups Planned analysis and analytic methods described in the Statistical Analysis plan, to be used of the results of the study to adequately assess the effects of the drug. www.diahome.org
Ex. of an Adequate and Well-Controlled Most (All) should be defined prior to start of trial: • Unblinding Plan • Statistical Analysis y Plan • Data Management Plan • Randomization Plan • Drug Distribution Plan 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 and 10: ICH GCP E6 E 6, Ch Chapter t 88: ii
Page 11 and 12: Anything Missing? Are there any doc
Page 13 and 14: Ex. of Quality Systems Documents De
Page 15 and 16: Ex. of Electronic System Documents
Page 17: Ex. of Safety Monitoring Documents
Page 21: Thank you for the opportunity to ta

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

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