An eTMF system also known as an Electronic Trial Master File System is something you have probably heard of if you work within the life science industry, but what is an eTMF system actually used for and do you need one?
What is an eTMF?
Every organization, typically a pharmaceutical or a biotech company, involved in a regulated clinical trial must comply with government regulatory requirements surrounding those clinical trials. One of the key criteria to fulfil regulatory compliance is to maintain and store certain essential documents related to that clinical trial. Essentially, a Trial Master File is a set of essential documents and content that shows how a clinical trial was conducted, managed and followed regulatory requirements. These essential documents allow for the evaluation of the conduct and quality of the clinical trial.
Traditionally trial master files would have consisted of numerous folders containing paper copies of all the documents required for possible regulatory inspection however, paper TMF systems come with huge disadvantages;
- Hard logistically to transfer physical folders from A to B
- Hard to find specific documents
- Easier for things to get lost
- Harder to manage- may need to employ an administrator just to file/organise the documents
- Can be more time consuming and time is money after all
Benefits of an eTMF
As we move to an electronic way of life this is no different in the life science industry with the introduction of many electronic clinical trial applications such as electronic case report forms (CRFs), electronic patient reported outcomes, electronic data capture etc. There are many advantages to the use of electronic systems, particularly eTMF systems and many organisations involved in the clinical development process are seeing huge benefits in efficiency after switching from a traditional paper TMF. Apart from efficiency other benefits include;
- Improved accessibility
- Easier to search, find and view documents
- Improved Audit & Inspection Readiness
- Streamlines the overall process
So if you’re engaging in clinical trial activity it is probable that you will be required to interact with a Trial Master File (TMF) at some point. Moving to an electronic TMF is a decision that can offer a huge number of benefits but as a minimum your system should allow you to create and manage documents with a sufficient audit trail should you require an inspection.
Datatrial have recently developed an eTMF module, which will be accessible through our collaboration tool Nucleus. For more information get in touch at www.datatrial.com