Maintain Your Trial Master File Like the Pro You Are
Regulatory and research organizations are charged with the task of creating, updating, and maintaining TMFs, or Trial Master Files. It’s vital that companies proactively plan, collect, and keep up with the TMF content throughout the duration of each trial in order for that TMF to serve as an effective trial management tool, as opposed to a burden and a hassle.
There are some crucial recommendations that organizations must take into account when preparing a TMF. Being aware of these is the first step in making sure your TMF processes are nothing short of perfect:
- First and Foremost
Keep in mind that with research, if it isn’t written down, it never happened. It’s easy to get busy managing trials every day and neglect documentation; however, remember that it’s that documentation that supports all activities and steps that are carried out. If problems arise, it’s that documentation that is going to help resolve them – but not if it doesn’t exist. If a regulatory agency conducts an inspection, your word isn’t going to suffice in regards to work that was done.
- Keeping Current with Updates
Always be sure to maintain your files in a timely manner; since the file is the keeper of all the documentation needed to reconstruct the trial, in addition to vital decisions made regarding it, the TMF must be created right at the beginning and maintained throughout – not as an afterthought.
- Timeliness of Filing
Be sure that your organization isn’t guilty of filing documents retrospectively and instead, is filing appropriate documents as they are completed. Delaying filing can create gaps in your TMF. Be sure to have quality control processes in place to ensure any gaps are identified and remediated in a quick fashion.
- Define Roles and Expectations Early
Even the best system will only be mediocre if there is no clearly defined support process. A failure to define roles and expectations can easily lead to confusion by stakeholders as to what timeliness are for filing, who is responsible for functions, and which parties are in charge of filing which documents. People have a difficult time performing their responsibilities when it isn’t clear what their responsibilities are.
- Be Sure Processes are Optimized
This is a big one. While most organizations do have processes for TMF management in place, they are often vague and not reflective of the way their people actually work. Optimize your TMF platform to be specific. Understand how your teams work together and draft specific – not general – processes that can be followed. Avoid falling into the trap of thinking that boilerplates are sufficient – they aren’t.
- Cultivate Your TMF Culture
Organizations who are successful at maintaining excellent TMFs are those that constantly stress the importance of that upkeep within their personnel. The TMF should always remain at the top of the priority list, because it’s not just about being able to answer an inspector’s questions with it: It’s about producing required documentation to support your trial entirely.
- Training, Training, Training
End users must understand the system and the structural hierarchy of your TMF. They need to have a firm grasp of who is responsible for what, and timelines must always be clearly defined. Define naming conventions and ensure that the process of documentation uploading is clearly understood.
- Validate, then Validate Again
A TMF management system needs to be in place where the system is validated; in addition, the security on that system needs to be validated. Validation is just one crucial component of developing a good document practice strategy.
- Keep It Inspection-Ready
Quality control is the key here, and ongoing QC should be done with metrics that indicate the health of your TMF at all times. Reporting is needed on what documents should be filed, along with which documents have already been filed. Reporting can also include duplicate filings and documents that haven’t been filed correctly. Ongoing QC work ensures that your organization’s TMF will always be inspection-ready.
Keep in mind that regulations require that a readily available Trial Master File be established and maintained. Make it a point right from the start that your organization must remain in compliance with the principles of Good Clinical Practice (GCP) and that anything less is unacceptable.
Not only will maintaining an excellent TMF ensure smooth audits and comprehensive details of all the work being done, but it will also help your organization maintain a smooth running of the trial. Any future inspections will be no cause for panic, alarm, or undue stress (not to mention delays) with an excellent TMF management system in place.
Learn more about maintaining an inspection-ready Trial Master File and discover vital take-aways at one of our trial master file events coming up. Seating is limited, so sign up today.