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EU Clinical Trial Regulation Impact
This is a forum to discuss thoughts or concerns and to raise questions about the potential impact of the EU Clinical Trial Regulation on the TMF and TMF management. Please take a look at the summary document from the April 2022 workshop on this subject - available HERE.
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- 2 weeks, 5 days ago
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General Discussion Forum
This is an informal chatroom for those interested in the TMF Reference Model and its application. Please note: Do not use this facility as a marketing tool or to promote conferences, events, etc. Also, please do not use it to ask questions about meeting times or other "admin" queries. It should be restricted to conversations about TMF Management and the Reference Model Project ONLY. Read-only access is available to anyone. Only registered users are able to post.
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- 1 week, 4 days ago
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Where do I file…. ?
If you are not sure where a particular document should best be filed or need guidance on what a particular zone, section or artifact is for, please submit your questions here.
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- 1 week, 3 days ago
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eMail Communications
For all questions relating to eMail communications in the TMF including filing, naming and archiving
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- 1 year, 3 months ago
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Adopting the Reference Model
Post here for queries related to interpretation, adoption and implementation of the TMF Reference Model. Please don't post "Where do I file XXX" questions; there's a separate section for those!
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No Topics
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Archiving
Post here for queries related to the LONG-TERM ARCHIVAL STORAGE of TMF content (physical records or digital). This is not a forum for "filing" of TMF content; only for how you archive the TMF toi comply with regulatory requirements for long-term preservation of the TMF.
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- 1 month, 2 weeks ago
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TMF Management, Content & Processing
Post here for queries related to the management of the TMF. This includes topics such as what content comprises the TMF (use "Where to file" forum for those specific questions), how to establish and manage the TMF, things to consider when processing TMF documents.
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- 1 month, 1 week ago
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Signatures
Post here for queries regarding signatures, eSignatures, approving documents, and related topics.
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- 2 months, 2 weeks ago
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Project News
This forum will be used to give you quick updates, reminders about meetings etc.
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- 1 year, 5 months ago
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EU Clinical Trial Regulation Impact
