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Trial Master File Reference Model
Trial Master File Reference Model

(a Community Group now part of CDISC)

Current version: TMF Reference Model V3.3

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Trial Master File Reference Model
Trial Master File Reference Model

(a Community Group now part of CDISC)

  • Home
  • About the Model
    • About the Model
    • CDISC TMF Reference Model Steering Committee
    • Intellectual Property Rights Policy
  • Community Exchange
    • FAQs
    • Forums
    • Resources
    • Exchange Mechanism
      • EMS News
      • EMS Roundtables
    • Resources Archive
  • Change Requests
  • Help
  • Login
  • Subscribe

Home › Forums › Topic Tag: Part 11

Viewing topic 1 (of 1 total)
    • Topic
    • Voices
    • Posts
    • Last Post
    • Hipaa and Part 11 compliance for IP (Device)

      Started by: Jane Marie Johnson in: Where do I file…. ?

    • 1
    • 1
    • 3 months, 3 weeks ago

      Jane Marie Johnson

  •  

Viewing topic 1 (of 1 total)

Recent Discussion Topics

  • PIA (=privacy impact assessment)
    1 week, 3 days ago
  • Declaration of Interest
    2 weeks, 5 days ago
  • Is eTMF access control necessary for multiple CROs?
    1 week, 4 days ago

Relevant Links

  • TMF Reference Model Initiative Charter
  • Webinar – EU CTR & eTMF Impact
  • CDISC Affiliation Position Paper
  • TMF Reference Model v3.2.1
  • EDM Reference Model
  • eTMF Exchange Mechanism Standard Presentation
  • eTMF Exchange Mechanism Standard v1.0.2

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