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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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Reply To: Use of DocuSign in TMF

Home › Forums › Signatures › Use of DocuSign in TMF › Reply To: Use of DocuSign in TMF

March 20, 2020 at 8:05 am #2924
Antwanette Heyns
Participant

Hi Laura
We use DocuSign and yes it must be Part 11 compliant.

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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

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Recent Discussion Topics

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

Next General Meetings

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  • May 11, 2020
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  • July 27, 2020
  • Sept 21, 2020
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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

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