Talk:Trial master file

Requested move

The following discussion is an archived discussion of a requested move. Please do not modify it. Subsequent comments should be made in a new section on the talk page. Editors desiring to contest the closing decision should consider a move review. No further edits should be made to this section.

The result of the move request was: page moved. Wikipedical (talk) 02:46, 11 September 2012 (UTC)[reply]

Electronic trial master file → Trial master file – A significant part of the content of the existing article is equally applicable to trial master files in hard-copy and electronic format. A Wikipedia entry for trial master files generically does not exist and it does not make sense to have 2 article on Wikipedia.... one for electronic trial master files and one for hard-copy trial master files, since the regulations governing these apply to trial master files in all formats. It is therefore suggested that the article name is changed to "Trial master files" and the content of the article can then be revised if necessary and developed further to include generic issues, issues specific to hard-copy trial master files and issues specific to electronic trial master files. Rammellconsult (talk) 08:37, 6 September 2012 (UTC)[reply]

The above discussion is preserved as an archive of a requested move. Please do not modify it. Subsequent comments should be made in a new section on this talk page or in a move review. No further edits should be made to this section.

In fact, electronic trial master files (eTMFs) are significantly different from paper based Trial master files. For one thing, eTMF are recognized as electronic systems, and are therefore subject to regulatory rules and laws that TMFs are not subject to. Electronic systems are subject to FDA CFR Part 11 rules in the US: [[1]]

In the EU, eTMFs are subject to European Medicines Agency rules for electronic systems. TMFs have a different set of regulations since they are non-electronic, paper based systems:

[[2]]

Additionally, this article seems more like an advertisement for the DIA - there are no verifiable references in this article, and the article should be reworked to include references to TMF requirements in EU and in USA at a minimum. — Preceding unsigned comment added by Cogitari (talk • contribs)

Cogitari, ~~it appears that you have again removed the section on eTMF, without even acknowledging that in your edit summary. Can't you turn it into something useful instead of just pretending it doesn't exist.~~ Never mind, I see you worked it in. Thanks.

Also, please note that per MOS:CAPS, we use sentence case for headings and we don't unnecessarily capitalize things like trial master file. Dicklyon (talk) 00:09, 10 May 2013 (UTC)[reply]

Addition of International TMF Day reverted

I am enquiring as to why the information added about the International TMF Day was removed? The industry is trying to raise the awareness of the importance of the TMF and so the International TMF Day was created to help with this matter. It is supported by two CDISC TMF Steering Committee members: Karen Roy (Chair) and Jamie Marie Toth (incoming Chair) (see Steering Committee list: Trial Master File Reference Model | CDISC) who were also referenced (also reverted). Please consider this information being added in to help support the TMF community. HitchingSarah (talk) 16:06, 11 June 2025 (UTC)[reply]

Amalgamate TMF and eTMF

I know this was raised before in 2012, but the TMF industry has moved on a lot since then. Most companies now keep their TMFs electronically in a eTMF system, with the paper TMF becoming less and less used. Guidelines and regulations that cover TMF have evolved and apply to both electronic and paper TMFs. I would strongly recommend to amalgamate and update the TMF and eTMF articles to fit with current industry thinking. HitchingSarah (talk) 12:07, 13 June 2025 (UTC)[reply]