Managing the TMF Index (eTMF)

The TMF Index captures your TMF metadata document type structure that defines the document type and its use, and business process information. eTMF Vaults include standard objects, fields, and lifecycles to help you define, manage, and version your TMF Index.

The TMF Index functions as a table of contents and navigational aide to the TMF. Types of users that consult the TMF Index include:

  • Internal teams, who consult the TMF Index for instructions when uploading, classifying, and processing TMF documents
  • Inspectors, who consult the TMF Index and compare it with the metadata and history of TMF documents while navigating your document type model

Updating the TMF Index

TMF teams regularly update their TMF Index because of business changes such as organizational changes and SOP updates. When a TMF team updates their TMF Index, they may also update their Vault configuration and records to reflect the latest version of the TMF Index, including changes to:

  • Document type configuration
  • Document field configuration
  • Object and document metadata such as EDL information and milestones
  • Document lifecycle configuration
  • TMF Index Version: Contains all information for a particular version of your TMF Index.
  • TMF Index Item: Individual artifacts and document types within a particular version of the TMF Index. Typically, you will have one record per document type for a TMF Index version. You can identify records for inactive document types by setting the Retired checkbox.
  • TMF Index Item Requirements: Detailed requirements for TMF Index Items based on Level, Country, and organizational factors captured in the Study Index Type field such as business unit and study type. Types of requirements include owning department, requiredness, and linkage to different types of milestones that drive EDL Item Template configuration.
  • TMF Index Change Request: Proposed and implemented changes on individual TMF Index Item records in a particular version of the TMF Index.
  • Index Change Impact Assessment: A detailed overview of the potential impact of one or more change requests for a particular version of the TMF Index. Impact can be quantified in a series of numeric fields and detailed in a more qualitative fashion in text fields. You can also link a record to a document if you want to store the impact assessment as a document in your Vault.

Managing the TMF Index via Lifecycles & Workflow

Your organization can configure workflows to transition TMF Index-related records through the various states of draft, review, approval, and implementation per your business processes. For example, changes to the TMF Index often go through a review process before they are implemented.

A common practice is to control access to the TMF Index, allowing many users to view only the currently implemented version, while only a select group of users can view obsolete versions and view or edit a new draft version.

TMF Index Lifecycles

The following standard lifecycles with standard states support the management of the TMF Index:

  • Index Change Impact Assessment
  • TMF Index Change RequestTMF Index Item Lifecycle
  • TMF Index Item Requirement Lifecycle
  • TMF Index Version Lifecycle