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Many organizations operate using an existing “tree” structure, which they’ve employed in previous paper Trial Master File systems. However, as companies begin to adopt electronic Trial Master File (eTMF) systems, the design of the structure becomes increasingly more important in regard to the efficiency of the trial. As the capabilities of eTMF far exceed the constraints of current paper-based systems, organizations need to focus on restructuring the design process to maximize their trial results.

In the first phase, the existing tree structure involves asking the questions, “What are you going to collect?” and, ”How are you going to store this information?” In most instances, organizations have disparate systems for regulatory documents and site initiation documents. Although this provides a good starting point for data storage, with eTMF, organizations now have the ability to extend this design to include source worksheets, eCRFs, safety documents, IRB information, contract information, correspondence, images, etc., essentially incorporating all the necessary clinical trial information to be stored. This integrated solution is designed to maximize results by expanding the eTMF system from a simple data repository to an interactive system that provides users controlled access to all data during the trial.

The second phase focuses on determining when to incorporate electronic signatures and notifications. It’s important to identify which data requires electronic signature and/or notifications as they can be set up at the individual or group level. Electronic notifications are used globally by clients with eTMF experience—these are important as they effortlessly track expiration dates on FDA 1572s and offer notifications of incoming safety data critical to the clinical trial.

During phase three, organizations determine how users will interact with the data, and grant authority accordingly. For example, some users can only read or view the data, while others will be able to edit the database and approve documents. This becomes a cube function, meaning that all documents need to be cubed to determine the number of variations possible (i.e. 20 document types means 8,000 variations).

The final phase is testing the eTMF prior to deployment–this is an important step as the user combinations, now limitless, start to provide extensive testing matrixes. eTMF documents are much more complex and exponentially larger than traditional TMF. With the complex information now available within the eTMF, it is paramount to ensure that the right users have access to the right documents. Therefore, a technology partner with the ability to do this legwork ahead of deployment not only gives the sponsors increased value in the long run, but reduces any risks associated with electronic access to the wrong users.

Once the eTMF is deployed live, the system will likely be amended to incorporate the changes that affect most trials, secondary and tertiary informed consents. This needs to be accomplished with version control along with the necessary audit trails to documents changes made to the system. At the conclusion of the trial, the eTMF should lock, at the same time as the EDC, providing the sponsor with 100% of their documents.

eTMF systems should be easily designed, produced, tested and deployed within a matter of days–otherwise, sponsors are missing out on the true value these new systems bring to the market.

About the Author
DeSanti has over 25 years experience in the pharmaceutical industry working at companies such as Johnson & Johnson and Walsh Americas. In 2005, recognizing the need for a broader range of technologies to curb research costs and streamline the trial process from start to finish, he founded PharmaVigilant, and began the task of meeting pharma’s crucial trial demands.

This article was published in Drug Discovery & Development magazine: Vol. 13, No. 6, July/August, 2010, p. 11-12.

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