5 Ways to Improve Your TMF: Lessons from the 2015 TMF Summit

February 12, 2015

  • eTMF Resources

Last month, TMF users and experts met in Arlington, VA for the 4th Annual ExL Pharma TMF Summit. The three day conference focused on TMF best practices, and featured speakers from various roles in pharmaceutical companies, CROs, consultants, and eTMF vendors. The presentations covered a range of topics applicable to organizations of every TMF level – paper, electronic, hybrid, or currently transitioning. Whether your trial is 100% paper, 100% electronic, or 100% outsourced, the experts had tips for maximizing the effectiveness of TMF. Here are the top 2015 TMF Summit’s Top 5 Lessons to Improve Your TMF.

1. Create an eTMF mindset in your company by integrating the look and feel of eTMF into current paper processes.

While many organizations are willing to make the jump from paper TMF directly into eTMF, others may take more time. By making small, incremental changes to your company processes, you can gradually prepare your organization to take on eTMF in the future. For instance, by implementing standard naming conventions, your company will begin to experience some of the benefits of an eTMF on a simple shared drive. This will also introduce individuals to eTMF concepts such as metadata and electronic search.

– David Benedict – Global Monitoring Operations, Actavis

– Eric Rubinson – Regulatory Affairs Operations, Actavis

2. Successfully implement a TMF migration by defining a project plan and set of specific requirements at the beginning of the project.

TMF migrations can comprise a significant portion of an eTMF project in terms of cost and effort. Determine the business goals of a migration as early as possible in order to meet stakeholder expectations, maximize return on investment, and allow your organization to operate within an overall framework for inspection readiness.

-Kathie Clark, VP of Product Management, Wingspan Technology

For more help with your eTMF migration project, request a copy of Wingspan’s eTMF Migration Toolkit. Featuring a migration project plan, worksheet, and white paper, this toolkit will help guide you through the migration process.

3. Ensure inspection readiness with a TMF plan and periodic TMF quality check process.

Before beginning a study, define the required timing for quality check and directions to QC the TMF. Identify an algorithm showing minimum review that increases review based on findings. Develop an internal audit plan with QA, and conduct internal audit often, especially during the early stages of the study. This allows times to address issues before facing an actual inspection.

– Curran Murphy, CPM, Cerulean Pharma, Inc.

4. Use metrics to improve CRO results.

Establish expectations and monitor a CRO’s work throughout the course of a trial by setting KPI’s for your study’s timeliness, quality, and completeness.

Timeliness: Ensure completeness and volume of documents submitted on a monthly basis. Determine a specific number of documents expected for each month (depending on the monitoring activities, sites, Countries and Regions). Require the CRO to send an excel spreadsheet with the amount of documents that were sent in each month.

Quality: Within your contract with your CRO, identify e a quality threshold for findings. This means determine the acceptable percentage of documents submitted to the Sponsor from the CRO that return from QC with findings. Periodically review document quality to ensure the CRO is meeting this standard.

Completeness: Evaluate the eTMF completeness and potential issues with documents missing from eTMF by reviewing a sample of documents from one or more sites. By comparing the number of expected documents to the number that have been archived, you can identify the level of completeness for each site and the overall TMF.

-Fabio Rodrigues, Clinical Manager, Medical Division, Boehringer Ingelheim

5. Maintain a compliant TMF across multiple global sites by creating a plan for initial setup, maintenance & archiving for outsourced studies.

Begin by determining a TMF Plan and SOP structure. Map the CRO and sponsor structures to the TMF Reference Model. This will allow for a clearer gap analysis. Maintain the TMF throughout the course of the study with periodic reviews between the Sponsor and CRO and internal audits, which should be planned and outlined in the CRO contract at the beginning of the study. For archiving, consider in what format the TMF will be returned to the Sponsor.

-Andrew Waite Director, Records and Information Management, AMGEN