Skip to content
Trial Master File Reference Model
Trial Master File Reference Model

(a Community Group now part of CDISC)

Current version: TMF Reference Model V3.3

  • 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
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

Metadata

Home › Forums › TMF Management, Content & Processing › Metadata

Tagged: Attribute, Metadata

  • This topic has 0 replies, 1 voice, and was last updated 10 months, 4 weeks ago by Vaibhav Funde.
Viewing 0 reply threads
  • Author
    Posts
    • July 15, 2022 at 4:19 pm #4694
      Vaibhav Funde
      Participant

      Hi All,
      In TMF tool we captured metadata/attribute from document content, but sometime we follow default values for some metadata when those things are not available in document content. Scenario 1- Protocol Version Number is not available on Protocol Signature Page, do we need to mention default value for this document for Version Number metadata or we need to refer any document such as Protocol document filed at Trial or Country which gives correct value for this document.
      Scenario 2- Financial D disclosure form document site number not mentioned in document but comment provided below Site ID as keep blank if unknown do we still capture Site ID metadata for this document.
      Any guidance document on this issue clarification is most welcome..
      Please provide your valuable opinion on above issue..
      Thank you.
      With Regards.
      Vaibhav Funde

      • This topic was modified 10 months, 4 weeks ago by Vaibhav Funde.
  • Author
    Posts
Viewing 0 reply threads
  • You must be logged in to reply to this topic.
Log In
Post navigation
Next Topic →

Recent Discussion Topics

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

Copyright © 2023 Trial Master File Reference Model | Powered by Astra WordPress Theme