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Subject: Proposed Charter for OASIS Electronic Trial Master File (eTMF) Standard TC

I would like to make the following additional comments on the proposed charter for the OASIS Electronic Trial Master File (eTMF) Standard TC:


[1]      Problem to be solved. Insert before 2nd sentence: “For those with access to CMS systems, a method to exchange content via cloud services is needed.”


[2]      (1)(c) Scope of work. Additional sentence at the end of point (1): “We will seek input during the initial stages of work from key industry groups including, but not limited to, CareLex, clinical trial sponsors, Document & Records Management DIA Community, NCI Thesaurus, SAFE-BioPharm, technology vendors, and TransCelerate BioPharma. Input will be incorporated into the general statement of need.”


[3]      (1)(c) Scope of work. Include “TMF Reference Model v2.0” in the list of published sources in (3). List sources in alphabetical order.


[4]      (2)(a) Similar or applicable Work. Number the listed works i.e. CareLex eTMF model is (i)


[5]      (2)(a) Similar or applicable Work. Item (ii) in the list is: “The TMF Reference Model contains a classification hierarchy of clinical trial artifacts which is based upon the principal regulatory requirements for trial master file content in the three ICH regions (USA, EU and Japan).”


[6]      (2)(h) Initial Contributions. Include URL for the TMF Reference Model i.e. http://www.diahome.org/en-GB/News-and-Publications/Publications-and-Research/EDM-Corner.aspx


[7]      (2)(h) Initial Contributions. Add the following to the list of initial contributions:


·         US Code of Federal Regulations, 21CFR11, Electronic Records, Electronic Signatures

·         ISO 32000 / PAdES specification

·         SAFE-BioPharma published standards for digital signatures

·         FDA guidelines for digital signatures (reference unknown)

·         European Commission Directive 2001/83

·         European Commission Directive 2005/28

·         EMA Reflection paper on GCP compliance in relation to trial master files, Feb 1, 2013









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