When you’re running a clinical trial, you need to make sure that your records, from protocols to results, are compliant, organized and managed so that they’re always ready for inspection. You can do this by effectively managing your trial master file (TMF) – a crucial element of a successful trial.
Many trials employ a specific person to manage their TMF – a TMF Study Owner – who can not only ensure the TMF is up-to-date and compliant but also report back on progress against key performance indicators (KPIs) and identify any documentation gaps or timeline slips.
However, even with a dedicated team member, a manual TMF can be unmanageable, especially for a large or complex clinical trial. This is where technology becomes essential: electronic trial master files (eTMFs) have revolutionized the way we track clinical trials.
At Siron Clinical, we have been partnering with eTMF provider Montrium since March 2020, giving our clients access to the cutting-edge technology they need to ensure more efficient and effective trial processes and greater regulatory success. Here we look at some of the reasons an eTMF is vital to a clinical trial.
An eTMF contains all of a clinical trial’s essential documents. According to Good Clinical Practice (GCP) guidelines, these are documents that “individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.” Inspectors can use the eTMF to check the compliance of the investigator, sponsor and monitor with GCP and any applicable regulations.
Many regulators provide guidance for the management of eTMFs. For example, the European Medicines Agency (EMA) guidelines from 2018 outline everything from the structure of the system and security issues to the length of time a trial sponsor needs to keep the files archived. And the FDA’s regulation CFR 21 Part 11 addresses the use of electronic records, digital media and digital signatures in clinical trials. To make sure your eTMF helps keep your trial compliant, it’s important to work within the guidance of the relevant regulatory bodies.
Identify and fill gaps
Provided the eTMF is managed according to guidelines and contains all the documentation and other information regulators need, it can be an invaluable tool for ensuring the success of a trial. One of the great benefits of an electronic TMF over a traditional one is that it is much easier to identify and fill gaps.
With an eTMF, you can collate documentation and data that would be impossible to do on paper. An eTMF can highlight areas of concern, missing information and tasks that need to be completed. It lets you track and tell the story of your clinical trial from start to finish.
Although there is no standard for the structure of an eTMF, they are usually based on the Trial Master File Reference Model – a taxonomy for organizing information related to a clinical trial. More complex trials will usually be structured first globally, then by country and then at the site level. And in general, an eTMF has two parts – one managed by the sponsor organization and one by the investigator – which are kept separate for confidentiality.
Improve efficiency and reliability
With a traditional TMF, managing the huge amount of information that comes with a trial is challenging, but the eTMF makes the process much more efficient. For example, you can:
- Access, approve, share and manage clinical documents anytime online
- Get documents ready fast for compliance inspection, reducing your regulatory risk
- Search and find documents faster
- Save time and money due to more efficient filing
- Access the right information at the right time, based on your profile as investigator, sponsor or monitor
The improved efficiency is one of the benefits we wanted to bring to Siron Clinical’s clients when we partnered with Montrium. The administrative burden of managing a traditional TMF can make completing a trial impossible; with an technology like eTMF Connect, trials have a much greater chance of succeeding.
Siron Clinical’s eTMF partnership
Siron Clinical has been providing clients access to Montrium’s cutting-edge technology since March 2020. When the partnership began, Jan Balemans, CEO at Siron Clinical, said:
“Montrium were the perfect choice of eTMF partner for us – they are at the forefront of providing electronic solutions to small and medium-sized companies. The benefit for Siron Clinical is that we can continue to improve and increase the effectiveness of our organization, allowing us to provide the right solutions to our customers.”Jan Balemans, CEO at Siron Clinic
We continue to work together to ensure our clients benefit from more efficient processes, higher quality documentation and less administrative burden.
Could your clinical trial benefit from a cutting-edge eTMF? Contact Siron Clinical to find out more.