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

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What about for Electronic Systems? Regulation/Guidance reference: Included Documentation: 21 CFR 11.10 Procedures and controls designed to ensure authenticity, integrity, and when appropriate, the confidentiality of electronic records records. 21 CFR 11.100 Procedures and controls designed to ensure that the signer cannot readily repudiate the signed records as not genuine. g -Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else, -Organization Organization shall verify the identity of the individual. individual -Certify to the Agency that the e-signatures are intending to be the legally binding equivalent of traditional handwritten signatures. EU 2005/28/EC Article 20 Any alteration to records shall be traceable www.diahome.org
Ex. of Electronic System Documents System Validation for Clinical Data Management System • Li Limiting iti system t access tto authorized th i d individuals • Use of secure, secure computer computer-generated generated timestamped audit trails • Database Lock and Release documentation • Revision and Change control process • Signature g validation forms 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: Ex. of Quality Systems Documents De
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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