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Trial Master File Reference Model

Trial Master File Reference Model

(a DIA Document & Records Management Community project)

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Topic Tag: Regulatory Green light

Home › Forums › Topic Tag: Regulatory Green light

Viewing topic 1 (of 1 total)
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    • Green Light documents (IP release documents)

      Started by: Gunilla Paulsson in: General Discussion Forum

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    • 1 week, 1 day ago

      Todd Tullis

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Viewing topic 1 (of 1 total)

Click on an event listed below to see details or to download a .ics file for your Outlook calendar

Upcoming Meetings and Events

  1. TMF Reference Model General Meeting (Sep)

    September 21 @ 4:00 pm - 5:00 pm BST

  2. Conference: European TMF Summit

    October 19 - October 21

View All Events

Recent Discussion Topics

  • Good Clinical Practice for Medical device
    1 week, 2 days ago
  • Green Light documents (IP release documents)
    1 week, 1 day ago
  • SAE Report (07.02.02 ) – who files at trial and site level?
    1 week, 2 days ago
  • Password protected records
    2 days, 3 hours ago
  • Master SAE report form
    1 week, 5 days ago

Next General Meetings

Click on a date below to download an Outlook Calendar .ics file:

  • May 11, 2020
  • June 22, 2020
  • July 27, 2020
  • Sept 21, 2020
  • Oct 26, 2020
  • Dec 12, 2020

Recent Posts

  • Announcing: Real-World Study Document Index
  • Announcing: Guidance for Managing Trial-related Emails
  • Steering Committee Elections
  • The do’s and don’ts of (MHRA) inspections
  • A ‘not-required’ artifact is shown as core. Why?

Relevant Links

  • TMF Reference Model v3.1.0
  • EDM Reference Model
  • eTMF Exchange Mechanism Standard Presentation
  • eTMF Exchange Mechanism Standard v1.0.1

Archives

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  • About the Model
    • Participate
      • Working Groups
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    • TMF Reference Model Steering Committee
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    • Feedback and Change Requests
  • FAQs
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    • EMS News
    • EMS Roundtables
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    • Events
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