Draft Specification, Section Appendix C

["MNJ (Maria Nymann Jensen)" <mnj@novonordisk.com>]

Definition of eTMF

Is a wiki-reference valid?

 

Consider to align with authorities, i.e. from EMA reflection paper:

 

A TMF is the collection of documentation that allows the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated. The requirement for a TMF is set down in Directive 2001/20/ECi Article 15(5) and the TMF forms the basis for inspection (Directive 2005/28/ECii Article 16). The TMF is used by auditors and inspectors to assess the compliance of the trial with legalisation and guidance and by sponsors, monitors and investigators for the management of the trial (Recommendations on the content of the trial master file and archiving iii Section 3 and Note for Guidance on Good Clinical Practice CPMP/ICH5/135/95iv Section 8.1).

_____________________________________

Maria Nymann Jensen
Competency Development Professional
Trial Management Anchor

Novo Nordisk A/S
Vandtårnsvej 114
DK-2860 Søborg
Denmark
+45 4444 8888 (phone)
+45 30793864 (mobile)
mnj@novonordisk.com

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