eTMF for the CRO: Key Points to Consider
February 27, 2013
- eTMF Resources
While attending ExLPharma’s 2nd annual Trial Master File Summit in late January, I noticed the emergence of a new TMF buzz topic based on audience feedback, panel discussions, and speaker presentations: the application of eTMFs to Contract Research Organizations (CROs). Many attendees were curious about the feasibility of eTMFs in CROs, and how this type of implementation may differ from that of eTMFs used by sponsors. Throughout the conference, questions regarding the similarities and differences between implementations were raised, discussed and debated. The following are some key points to consider when discussing the implementation of an eTMF for a CRO.
Ensure Complete Sponsor Integration
Similar to implementation in sponsor environments, it’s important to initiate a thorough analysis phase to begin a successful application. Make sure to not only analyze both your IT and business processes, but those of your sponsors as well. Your organization’s master list [comprehensive list of TMF documents] may differ significantly from that of your sponsors, and each individual sponsor will require a different set of documentation. To alleviate any discrepancies between opposing master lists, work towards creating a universal master list accommodating all of your sponsors in order to maintain consistency throughout your system and eliminate confusion, while still allowing distinct document types to be used for each sponsor.
Don’t Overlook Security
Consider sponsor security and how this will affect your system and its processes. Each sponsor must be able to access their own trials, and nothing more. Decide what types of roles your sponsors will have in the system, whether it may be monitoring the trials through reports and metrics, contributing documents, or participating in workflows.
It is important to consider how your sponsor can oversee and maintain responsibility over their trials. As stated in the European Medicines Agency February 1 Reflection paper on GCP compliance in relation to trial 5 master files (paper and/or electronic) for management, 6 audit and inspection of clinical trials:
“the sponsor is still responsible for the trial and will need to maintain oversight…, so access to the TMF (e.g. remote access to eTMF) may be necessary or the sponsor may decide that the CRO needs to provide specific documents to the sponsor”.
In other words, determine if your eTMF must allow sponsors to access trials documents directly, or whether you will provide periodic and final exports of documents that may be uploaded to the sponsor’s own eTMF. Planning sponsor accessibility ahead of time will not only help when selecting your eTMF system, but will also help set clear roles and security boundaries in the system.
Pick the Right System
As a CRO, you may have to process data from many different Clinical Trial Management Systems (CTMSs) that may use different commercial or custom software, and even process to support trials where no CTMS is used. When researching various eTMF products, keep in mind which systems are capable of processing disparate CTMS data, and how they will handle trials for which no CTMS data feed is available.
It is also important to consider eTMF reporting. Research the reporting requirements of your sponsors prior to implementing a system in order to ensure your eTMF will allow you to produce the reports containing the required information. Having a system that can produce automated reports can be more efficient and useful to your organization than having a system in which you would still have to manually gather, organize, and analyze data. This step is important in ensuring your eTMF system both saves time and improves your organization’s overall efficiency.
For CROs, having your own eTMF can also improve timeliness and reduce costs in maintaining the Trial Master File. Since your associates are already familiar with the system, training needs are reduced and processes can be executed more quickly compared with using a sponsor’s eTMF. The right system can help serve as a business asset that will allow you to improve communication and demonstrate compliance to your sponsors – which could be a factor in being selected over a competitor.
Will you charge back the cost of the eTMF to your sponsors? If so, consider whether your charges will be trial based, monthly based, site based, or a flat fee per trial. Have your plan for payment mapped out prior to implementation, and make sure your chosen process is clearly explained to your sponsors.
In these early steps of establishing your eTMF, it is important not to overlook the importance of regular and consistent communication. Be sure to involve your clients [both internal and sponsor], especially in the early stages of the eTMF project. Collaboration is one of the most important aspects of change management.