New Resources Available: Guidance on Date Conventions

Successful management of a TMF, whether in paper or electronic form, is highly dependent on the classification system (e.g. TMF Reference Model) and the ability for a reviewer to identify and locate documents by specific attributes, such as the document date. However, deciding which date to use as the “document date” can often be subjective and therefore creates inconsistency in file maintenance; or even worse, documents can be perceived as being missing because a document is misfiled or mis-classified due to an arbitrary selection of the document date.

The TMF Reference Model Project’s Date Conventions workgroup was formed to solve this problem. It is comprised of individuals who represent a wide variety of perspectives, enabling the resource to be adaptable to all users and environments. The group consists of representation from:

  • Large and small organisations
  • Pharma, CROs, eTMF vendors and non-profit
  • Paper TMF, eTMF and hybrid environments
  • Numerous functional roles, from the daily operational end-user to the TMF Specialist

This workgroup is excited to announce the release of two new resources which bring together these decades of experience, in order to improve consistency in TMF management:

  • Suggested date conventions added to the TMF Reference Model for each artifact (see column AD)
  • A supplemental guidance document that provides:
    • Rationale for creating date conventions
    • Definitions for common terms
    • Standard rules by document type and for ambiguous dates (e.g. month and year, but no day) and date format
    • How to implement date conventions within your organisation

These two resources are now available to download on our Resources web page.

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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