I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the records and sometimes the CRO offers remote access to the eTMF via a web link.
Actually, the situation is very similar to the use of an electronic data capture (EDC) system…. the same sort of questions should be asked and the same principles apply. Firstly, it is critical that pertinent questions are asked during pre-study discussions with the CRO and well before the study actually starts. The CRO and sponsor need to agree (a) in what format the documentation will be returned, (b) what medium will be used and (c) the timing of the transfer. The answers to those questions have many dependencies but one of the most important is whether or not the sponsor has a system that the eTMF data can be imported into. With the advent of the DIA TMF Reference Model, the possibility of electronic document interchange between systems is becoming a real possibility. However, for most sponsors and CROs, this is not usually possible.
Although CD-ROM or DVD are acceptable transfer media, I would not recommend them as archival storage media as their longevity is very questionable. If CD-ROM/DVD is used to transfer the eTMF between CRO and sponsor, the content should be integrated into the standard IT infrastructure of the sponsor once in-house i.e. transferred to an electronic archive store or to a secure network storage location where it will be regularly backed up.
I would not necessarily advocate relying on a web link provided by the CRO unless (a) the CRO could be relied upon to maintain the hardware/software in order to access the data across its lifetime and (b) there was a reliable internet connection. If these two requirements were satisfied, this could be an acceptable approach so long as the necessary service level agreements were in place and there was documented due diligence regarding the CRO and its systems. This really is just a form of Cloud storage.
The format of the eTMF is another important issue. If the data is not being integrated into an existing sponsor eTMF and the CRO are not providing and maintaining web access, then the eTMF needs to be transferred in a format which facilitates easy accee to the content over a long period of time. The data therefore needs to be system independent i.e. NOT saved as a docbase or database that is reliant on proprietary document management software for access but rather as a file structure of individual electronic documents, preferably saved in PDF/A format. Search portals can easily be built using products such as Microsoft’s SharePoint to access such data stores. As a last resort, the CRO could print down the content but this should really be avoided if at all possible!
Lastly the issue of timing. This is often overlooked during initial discussions between sponsor and CRO but there needs to be an agreement on when the transfer of the eTMF will take place. Also agreement on what content the CRO will remove and retain i.e. any CRO-specific content.
Make sure you have answers to these questions BEFORE your clinical trial starts…. not when you receive a CD-ROM in the mail from your CRO!!