Public review comments for etmf-v1.0-Metadata Vocabulary: Category 102

C115723 Column F (definition): The definition “recording compliance with government regulations and laws.” is not specific enough.

C79189 Column C (preferred term): The process for seeking and receiving approval to conduct clinical trials varies significantly globally. In many cases, there is no longer an explicit letter of approval. It would therefore be preferable to use a more generic term for this artifact, such as “Regulatory Notification”. This notification could consist of an approval letter – where those agencies provide it – but more commonly would consist of acknowledgement that a submission package had been received and the required number of days had elapsed to allow the trial to go ahead.

Column D (synonym): As described above, I suggest using “Approval” and “Authorization” as synonyms for “Regulatory Notification”.

Column F (definition): As described above, this document often does not include explicit approval/authorization. I suggest changing to “A notification received from a regulatory authority stating that the Regulatory Submission has been received and there are no objections to the trial progressing.”

C115702 Whilst understanding the rationale for maintaining alignment with the TMF Reference Model as much as possible, consideration should be given to removal of this subcategory, which only contains 2 content types. The 2 content types (export/import license and applications) could be considered documents necessary for trial approval and therefore be classified in subcategory 102.10 (Trial Approval).

Column C (preferred term): If this sub-category is to remain, the term “Investigational MEDICINAL Product” appears to exclude devices and other investigational products that are not medicines e.g. contrast media. I suggest using the term “Investigational Product”.

C115466 Column F (definition): Consider clarifying “clinical supplies”, for example “….supplies, including but not limited to comparator drugs, diagnostic equipment, laboratory equipment, IT equipment”.

C115551 Column C (preferred term): Please note that this documentation is not necessarily related specifically to “safety information”. The preferred term is therefore not accurate. Documentation included within this definition could include, for example, serious breaches of GCP (not safety related) or any other regulatory reporting obligation.

C115611 No issues

C115666 No issues

C115612 No issues

C115548 No issues

Eldin Rammell

Managing Director, Rammell Consulting Ltd.

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