If you are interested in learning more, you may request a recording of the webinar below. In the webinar, ShareVault, along with the LMK experts, dive deep into addressing both the challenges and best practices for maintaining a Trial Master File (TMF).
What are some of the most common mistakes that research and regulatory organizations make when preparing a Trial Master File (TMF)?
One of the things we see a lot is that organizations do not maintain their TMF in a timely manner. It’s almost an afterthought. Because the TMF contains all the documentation to sufficiently and adequately reconstruct the trial activities undertaken, along with key decisions made concerning the trial, it should be established at the very beginning of the trial and maintained throughout.
Timeliness of filing can also be an issue. Even if organizations are filing appropriate documents, they may be doing it retrospectively. This can lead to gaps in the TMF. For example, suppose there is an unsigned document in the TMF, but the required signature is from an employee that no longer works for the organization. Having quality control processes in place ensures that these types of gaps are identified in a timely manner and remediated as quickly as possible.
Another pitfall we see when organizations move to an eTMF is failing to clearly define roles and expectations. They implement a system, but they fail to define the supporting processes. If there are not clearly defined processes, it is often hazy to people (i.e. Stakeholders) what the timelines are for filing documents, who is responsible for each function and which parties are responsible for filing which documents. When you don’t have clear guidelines and expectations defined for creating and maintaining the TMF, then people will put it off because it’s not clear to them what their responsibilities are.
What recommendations do you have for implementing good TMF processes?
It’s rare that an organization will have no processes in place around TMF management, although we can’t say that never happens, but often their processes are very general and don’t necessarily reflect the way that people actually work or that optimizes the way the TMF platform is used. So, when implementing TMF processes, it’s important to take into account those considerations. What is the process you’re using? What is the functionality? It’s important to understand how teams work together and to draft specific processes that can be followed. A boilerplate is usually not sufficient.
What is the Golden Rule of research when compiling a TMF?
The golden rule of clinical trial research is that if it isn’t written down, it didn’t happen.
People get very busy managing trials on a day-to-day basis and putting out fires when they erupt and often neglect the documentation that supports and demonstrates all of the activities and steps that are being conducted day in and day out. When issues are encountered, trial managers, data managers, and the team prioritize addressing and solving those problems, as they should, but as a result, the documentation process falls to the wayside. There is obviously a need to resolve issues in order to keep the trial going, but at the end of the day if you don’t have the documentation to support what you’ve done, then you have no evidence that the work was done. If a regulatory agency comes in to conduct an inspection, they are not going to take your word that work was done and done in a certain way. They will require documentation. If it isn’t written down, it didn’t happen.
Why do you think some organizations are better at keeping their TMF up to date? What are the issues?
We definitely see varying levels of success across organizations with TMF management. Usually, when an organization struggles with TMF management, it’s because of a lack of resources. They are spread thin and don’t have the time or the dedicated people to perform those activities.
It can also come back to having clearly defined expectations. Someone might do something as ordinary as sending an email or engaging in a discussion, and they may not realize that it is their responsibility to document that activity.
It’s important to cultivate a culture within organizations that stress the importance of maintaining the TMF. The TMF can seem like a very abstract concept until you have to sit across a table from an inspector and defend what you’ve done in a trial by providing documentation. That’s often when it clicks for people. That’s when they realize that they’re not just answering an inspector’s questions, but that they’re required to produce documentation to support what they’re saying.
When should an organization seek outside help
We work with a broad range of clients and organizations of varied size. The decision to outsource is really a unique decision for each organization. I would caution organizations considering outsourcing the TMF process to realize that the responsibility for the content, management, and quality of the TMF ultimately resides with the sponsor. Although outsourcing is an option and may be a good strategic decision, it’s a mistake to think that outsourcing the TMF process absolves you of all responsibility for the studies you run.
What are some essential steps an organization can take in order to develop a good document practice strategy?
It’s important to have a TMF management plan in place where the system is validated, the security on the system is validated and the process of uploading documents into the system is understood. It’s also important to define naming conventions and have timelines clearly defined.
Training on the system is also imperative. It’s crucial that end users understand the system and the structural hierarchy, and who’s responsible for what.
How can an organization determine whether their TMF is inspection ready?
This is where TMF QC comes into place. It’s making sure you have ongoing QC work being done and having metrics that indicate TMF health. There should be reporting on what documents should be filed versus what has actually been filed. Other reporting may include other QC findings such as duplicate filings or misfiled documents. Ongoing QC measures and reporting on those findings should give an organization the confidence that they are inspection ready.
Remember, regulations require that a readily available TMF is established and maintained. While demonstrating compliance with the principles of Good Clinical Practice (GCP), the filing of documents in an orderly, timely manner also greatly assists the smooth running of the trial and any future audit or inspection.
Request a copy of the webinar for a more detailed overview of how to apply the golden rules of research to your trial master file.
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