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

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In Summary • As you can briefly see see, the ICH GCP Guidelines define the minimal contents of TMF. – Yet indicate that the guidance alone is not the only one to reference… f as the h TMF should h ld contain i ddocumentation i for “all applicable regulatory requirements” • Applicable regulatory guidance is not concisely located, nor available in a detailed list. – Leaving sponsors to interpret expected content �Industry accepted standards and consistent document nomenclature could move content and completeness of the TMF to be a non-issue. www.diahome.org
Thank you for the opportunity to talk with you today today. I can be b contacted t t d at: t mulcahy67@comcast.net l h 67@ t t 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 and 18: Ex. of Safety Monitoring Documents
Page 19: Ex. of an Adequate and Well-Control

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

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