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Planning for TMF Success

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Tackling the Trial Master File (TMF) can seem daunting at times. With so many moving parts and documents, it can get more difficult to manage as a clinical trial continually progresses. However, the TMF is essential as it tells inspectors the story of a study from beginning to end.  

Keeping the TMF up-to-date is crucial due to this very fact, but teams often struggle with getting it audit-ready due to disorganization and inconsistencies. Common challenges with TMFs (paper and electronic) are: 

  • Storing documents in several locations, making them difficult to access during an inspection.  
  • Limited collaboration between sponsors and CROs especially if there are different filing processes, systems, or incompatible software.  
  • Metrics can help provide key insight into organizational performance measures but  are also another source of frustration in TMF management because of the need to be updated regularly  

These challenges can be addressed with setting up a plan, specifically, a TMF plan which could help streamline processes.  

What is a TMF Plan? 

The TMF Plan details every aspect of TMF management. It sets boundaries and specifies who is responsible for specific TMF sections. It could contain a TMF Master List or TMF Table of Contents (TOC) that outlines procedures such as deadlines for each document, study reports, or specific milestones unique to each organization.  

The TMF Master List could also reference the Standard Operating Procedures, which describes each TMF document. Other types of information you might expect to see in this plan include TMF review frequency.  

What is the purpose of the TMF Plan? 

Transparency is key to building a high-quality TMF. The TMF Plan provides all information, data, and processes relevant to TMF management. This results in a complete TMF come inspection time and sets expectations for all parties involved. It is meant to keep sponsors, CROs, vendors, and other TMF stakeholders in the loop on everything from how documents are filed to the location of the TMF.  

What is the format of the TMF Plan? 

Having a TMF Plan is not required, but it helps keep everyone on the same page. It is especially important if the sponsor and CRO are both adding content and maintaining the TMF. Each organization will have its own approach as to how TMF management will work, and it generally helps to have TMF Plans that address the following TMF points:  

  • Official location 
  • Management procedure documents 
  • Breakdown of tasks & responsibilities 
  • Content filing processes 
  • Training and access management 
  • Structure  
  • How to add content  
  • TMF activity documents  
  • Formal archive plan 

The above will largely vary based on your organization’s needs, but it is a solid starting point in formulating your new TMF plan.  

Conclusion 

Some of the biggest obstacles in a clinical trial are putting together an audit-ready TMF and having the metrics to back it up. You can avoid any of the unnecessary stress of inspections by having everything laid out from the start.  

Having a TMF Plan in place gives your team and other stakeholders a micro and macro view of the TMF management process, from content procedures to specific deadlines when TMF deliverables are due. As a result, the TMF plan keeps everyone on track throughout the clinical trial and sets everyone on the right path for future successful inspections.  

TMF Building Blocks to Inspection Readiness Success

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An often-overlooked aspect of a clinical research study is the Trial Master File (TMF). As the backbone of every trial, the TMF houses all of the documentation describing all study activity in compliance with Good Clinical Practice (GCP) guidelines and approved protocols. With all of the moving parts involved in and outside of the TMF, it can be a constant challenge for all parties to keep up with. This is why it is so crucial to establish a foundation for success from the very beginning of a study.  

This article will discuss the building blocks of the Trial Master File in regards to how you and your team can set up, organize and manage an inspection-ready TMF.

How should you organize the Trial Master File?

Although there are TMF resources available such as the TMF Reference Model from Drug Information Association (DIA) and the general list of Essential Documents outlined in section 8 of the ICH E6 GCP guideline, it can be easy to lose track of documents without the proper TMF structures in place for your clinical trial. Overall, the TMF should be set up and divided into the following sections:  

  • Global/Core Files – This section contains documents used on a global scale. Trial-related, clinical or internal team reports, and clinical documents and templates are included here.
  • Country Files – This section contains country-specific documents. You can find documents from regulatory authorities and Ethics Committees, investigational product details, and country-specific documents and templates.
  • Local/Site Files – This section contains documents relevant to the sites participating in the study. There is usually documentation on Subject Information, site correspondence, monitoring, local laboratories, Institutional Review Boards/Ethics Committees, and site-specific investigational products or devices.

How do you manage the Trial Master File?

Management of the TMF can make or break a clinical trial. Without noting down study activity, we cannot prove that it even happened at all. While updating the TMF is not always the priority day-to-day, implementing measures and processes will help prevent any incomplete documentation or failed inspections in the future. Below are some strategies you can keep in mind for maintaining the TMF.

  • Training

First and foremost, everyone needs to be on the same page. From individual team members at a site to the CRO, each person and organization should understand the importance of maintaining the TMF and the procedures needed to do so. Make sure that the processes they are trained on follow the teams’ natural workflow if possible.

  • Clear Expectations

Even with the best training, sometimes we can go astray from protocol. The best way to keep everyone accountable is to have clearly defined roles, responsibilities, and expectations. Not only does everyone know what their part is in maintaining the TMF, but it also allows stakeholders to have an idea of how the study is progressing.

  • Self-Checks

Maintenance is not always enough when it comes to getting the TMF inspection ready. The team should also be conducting regular Quality Checks (QCs) of the TMF to ensure that it is up-to-date with all of the right documentation. Although time-consuming, it can make you more confident come inspection time.  

  • Bottom-line: Document Everything

At the end of the day, all of the effort put into managing trials will be in vain if it is not documented in the TMF. It’s not a matter of if you did the work, but rather, how you did it. Showing auditors a clear picture of the clinical trial with the documentation to back it up will make inspections easier for everyone.

Conclusion

By simplifying the organization and management of the TMF, you are also taking your team to the next level of enhancing your current TMF processes resulting in having a successful inspection from any regulatory authority.

Our Mission and Purpose

The mission of 2K Clinical Consulting, Inc. is to ease the burden of GxP compliance and to transform the effectiveness of professionals and compliance systems worldwide.

Our History

2K Clinical Consulting, Inc. is the vision of former FDA Investigator, Kimberly Kiner, who empathized with facilities and sites that struggled with understanding and complying with regulations. After years in the field, Kimberly transitioned into the private sector and acquired international experience in compliance, monitoring and study management while she worked for pharmaceutical and invitro/medical device companies as well as CROs. This work experience is what sparked her desire to work as a consultant for organizations such as the Association for Clinical Research Professionals and the Society of Clinical Research Associates. Kimberly later went on to train providers such as Compliance Online and Fx Conferences. This exposure became the gateway to connecting with other experts and teaching professionals resulting in an engaging experience for clients that closes the gap in best practices within the realm of compliance.