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

More documents

Recommendations

Info

What about for Quality Systems? Regulation/Guidance g reference: Included Documentation: ICH E6, 5.1.1 Written SOPs for compliance with protocol, GCP, and applicable regulatory requirements. -Trials conducted are in compliance. -Data are generated, recorded, and reported in compliance. Readable and processed correctly. EU 2001/20/EC Article 1 (2.) GCP – set of internationally recognized ethical and scientific quality requirements must be observed. -Designing, conducting, recording, and reporting clinical trials that involve participation of human subjects. --Provides assurance that the rights, safety, and well- being of trial subjects are protected. --Provides assurance that the results of clinical trials are credible. www.diahome.org
Ex. of Quality Systems Documents Defined and followed Sponsor and Studyspecific processes: • Standard Operating Procedures • Manuals, both at trial and site level • Working Instructions • Guidelines • Deviation documentation 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: Anything Missing? Are there any doc
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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?