Holistic TMF ManagementBeyond Document Management

Luana CaroneSolutions Consultant APAC, Sales Operations, MasterControl’s Australia office

To make life-changing products

available to more people sooner.

OUR MISSION

TMF Management: Beyond Documentation

▪ How TMF management includes, but is not limited to, document management.

▪ How to manage a TMF using paper or electronic processes.

▪ Configuring an electronic document management system (EDMS) to manage TMF artifacts and metadata.

▪ Project management’s role in TMF management.

▪ Using metadata to facilitate access and share TMF content with third parties (e.g., CROs, sponsors, sites).

TMF Management: Beyond Documentation

▪ What is the Trial Master File (TMF) Reference Model?

▪ Document Management vs. TMF Management – What’s the Difference?

▪ Setting up your TMF system for success:

▪ Creating a TMF checklist template.

▪ Establishing TMF artifact templates.

▪ Rights – The right document for the right people.

▪ Metadata – Getting the most out of your system.

#1

TMF Reference ModelIndustry best practice aimed at developing a consistent configuration and organisation of document categories, taxonomies, and metadata generated throughout a clinical study, which makes up the TMF collection of documents:

▪ Study initiation documentation.

▪ Ongoing study documentation.

▪ Study closeout documentation.

▪ Third-party documentation.

▪ Study site documentation.

TMF Reference ModelTMF Reference Model version 3.0 released June 2015.

▪ Developed by DIA SIAC Group, made up of over 100 industry experts.

▪ Applies to ALL clinical TMF documents (sponsor, site, etc.).

▪ https://tmfrefmodel.com/

The Hierarchy of the

TMF

▪ TMF Artifacts: Represent document categories.

▪ Artifact: e.g., Principal Investigator CV.

▪ Document: Each site will have its own Principal Investigator CV.

TMF Sections

TMF Artifact

TMF Zones

11

48

249*

TMF Reference Model Overview – TMF Zones

TMF Reference Model Overview – TMF Sections

2.1.1 Investigator brochure2.1.2 Protocol 2.1.3 Protocol synopsis2.1.4 Protocol amendment2.1.5 Financial disclosure2.1.6 Insurance2.1.7 Sample CRF

TMF Reference Model Overview – TMF Artifacts

#2

TMF on a File Share

▪ Create a TMF folder structure.

▪ Include document templates (where applicable).

▪ Copy / paste / modify structure and artifacts, as needed, for each new study.

TMF Sample Checklist Template

TMF Management: Paper / File Share

Create metadata to track details for each study.

TMF Management: Paper / File Share

Track site documents(i.e., Site #, All Sites, NA).

Column: filter by site.

TMF Management: Paper / File Share

May want to track who has rights to view the document(s).

Filter column by viewing rights.

TMF Management: Paper / File Share

Who is accountable for providing this document?

Filter column by accountable party.

TMF Management: Paper / File Share

Is the artifact part of a submission? (i.e., CSR)

Setting up default: (Yes/No), based on if TMF artifact will facilitate extraction for regulatory.

TMF Management: Paper / File Share

Track milestone dependencies for TMF artifacts.

Setting up default based on if TMF artifact will facilitate “milestone readiness” throughout the study.

TMF Management: Paper / File Share

Status of the TMF artifact.

TMF Management: Paper / File Share

Tracking expected “Due Date” and “Assignee” will provide more transparency on timelines and accountability.

Location: Will allow for communication of where information can be found. Including hyperlinks helps.

#3

Managing TMF: Electronic System

Ensure system allows for TMF artifact level granularity to ensure more flexibility:

▪ Artifact level rights

▪ Different artifacts have different rights (view, create, etc.).

▪ Artifact level workflows

▪ Different artifacts require different workflows/routes (some may not require a route at all).

▪ Artifact-level metadata

▪ Ability to assign artifacts to a specific site (i.e., Principal Investigator CV).

Create / import Document Wizard.

Managing TMF: Electronic System

TMF artifact level:

▪ Rights

▪ Life cycle

▪ Metadata

▪ Authoring templates

TMF Artifact Metadata

▪ Searching

▪ Reporting

▪ Organisers / folders

Why Use an EDMS? Features Ideal for TMF …

Feature Benefit

Document Types Allows users to preset features and functionality to be defaulted based on document type (e.g., different metadata, rights, workflows), and provides more automation.

Document Templates Allows for enforcement of document template use based on the type of document the user is creating.

Version Control (1.0, 2.0, etc. )

Allows users to track the history of documents as they once existed as well as their relationship with new versions of documents.

Life Cycle and Status(Draft, Approved, etc.)

Allows for the status of documents to be transparent, and ensures all users are viewing the latest versions.

Workflows / Routes(Default by topic)

Allows users to route document(s) for creating, editing, and approving documentation. Allows different paths based on document types.

Electronic Signatures Allows users to electronically sign documents, eliminating the need for written signatures and scanning.

Document Rights(View, Create, Edit, etc.)

Allows users to set different rights based on document type (e.g., Final Protocol documentation should be viewed by all. However, Study Management documentation should be viewed only by sponsor/CRO – not sites).

Some EDMS Gaps …

EDMS Does … EDMS Does Not …

Provide a list of documents you have. Provide a list of artifacts “pending” expected as part of the TMF.

Provide document types (categories) typically found in a TMF (assuming adoption of the TMF Reference Model).

Track who is responsible / accountable for providing missing content (e.g., sponsor, CRO, site, named user).

Provide current status of individual TMF documents (draft, approved, superseded, etc.).

Provide analytics for the completeness of the entire TMF or inspection readiness.

Provide individual document routes / workflows for TMF artifacts.

Provide milestone completeness / readiness metrics and analytics.

EDMS With TMF Management Provides …

Study Start-up

Study Start-up

Study Start-up

Study Start-up

Study Start-up

Study Start-up

Checklist of TMF artifacts expected

Link to TMF artifact document

Study information management

Study milestone tracking

TMF artifact status

Filtering of TMF checklist

TMF checklist management

(Export, Print, etc.)

#4

Implementing TMF In Your Organisation

Make the TMF Reference Model your own.

▪ The model is not intended to be used off the shelf. It can be adapted to an electronic or paper TMF.

▪ Certain artifacts are designed for pharma (some for MD) studies, while others are specific to medical device clinical studies.

▪ Certain artifacts are “core;” others are “recommended.”

▪ If possible, use a TMF management tool:

▪ Electronic: TMF management system and/or EDMS.

▪ Paper: Paper, file share, and TMF management checklist (e.g., Excel).

Develop a TMF Plan ▪ Define how records will be managed and stored during and after the trial, including study-

specific processes and documentation for archiving and destruction.

▪ Think of your plan as a TMF management SOP.

▪ Who, what, where, when

▪ A TMF plan is a must – regardless of paper or electronic.

Summary and Action Items

▪ Visit TMF Reference Model website: https://tmfrefmodel.com/.

▪ Create a TMF organiser / folder structure.

▪ Create/download TMF checklist template.

▪ For a free TMF checklist Excel template, visit:

www.mastercontrol.com/etmf.html.

Thank You!