Merck’s Adam Colley on TransCelerate’s SQT Initiative: Mutual Recognition for EDC System Training

We recently interviewed initiative leads from TransCelerate’s Site Qualification and Training (SQT) Initiative, and went into details on the varying information modules. However, SQT has also launched a special project aimed at improving Electronic Data Capture (EDC) system training efficiencies between sites and sponsors. Adam Colley, Director with Global Data Management and Standards at Merck, and EDC System Training program lead with TransCelerate, will elaborate on how SQT’s EDC initiative establishes a framework to enable improved efficiencies and further collaboration with training providers and sites.

Moe Alsumidaie: Can you elaborate on any feedback TransCelerate has received from sites regarding the EDC system training?

Adam Colley

Adam Colley: Everything that we do in our industry is regulated, we are bound to make sure all users of an EDC system are properly trained. That is what every sponsor, and EDC vendor is geared to doing. When TransCelerate's Site Qualification and Training (SQT) initiative started several years back, we sought feedback from investigators and site staff, and the issue of training time stood out. TransCelerate has been focused on trying to find a solution for this by offering a mutual recognition program that makes EDC system training recognizable by TransCelerate member companies who opt in, hence, reducing redundancies. You can imagine, when a sponsor is conducting a clinical trial, that basic non-protocol specific EDC system training can be quite substantial. In many cases, EDC system trainings tend to last more than 2 to 3 hours with multiple users at a site: principal investigators, sub-investigators and study coordinators; for one study, EDC system training commitment is already tens of hours. If you expand that to larger sites, where many site staff are involved in multiple studies from multiple vendors, then all of a sudden training time adds up quickly. That time could be spent on more important executional components of a clinical trial, such as site initiation, and enrollment. Through TransCelerate’s Mutual Recognition Program for EDC system training, site staff can save critical time.

MA: Do current TransCelerate member companies recognize sites that have undergone SQT EDC system training? Do sites need to undergo additional training and what EDC systems do sites become qualified to use?

AC: The program is EDC system agnostic. Today's EDC environment is a mix. Some sponsors have their own system, some EDC vendors are also taking some steps towards their own solutions for this; for example, some EDC vendors offer certifications to sites, which can then be applied to numerous studies.  What I’m hoping from this TransCelerate initiative is that we can enable a framework where everybody can coalesce, and hopefully stand in good stead for future technology changes and improvements.

It would be naïve of me to say that vendors are not hearing that same concern or feedback from their user base and their customer base. So they will be taking steps to develop equal recognition systems for their own particular systems.

MA: I have heard that study sites are a bit in angst about sponsors using so many different EDC systems. How can the EDC System Training Mutual Recognition Program address differences among EDC systems?AC: The TransCelerate mutual recognition program for EDC system training creates a framework that can enhance and simplify site training, and ultimately give sponsors some confidence in the process. The universal tenets that apply to everybody regardless of the EDC system and sponsors is that everybody has to be trained. There is no getting around that. You don't need to define minimum criteria in this particular instance because we know that all training providers create and deliver training that is adequate for their system and if it wasn’t, I am very confident that regulatory bodies would quickly change the situation for that training provider. The other universal truth to this is that EDC systems generally don't change from sponsor to sponsor. The functionality and the experiences of EDC system users by one sponsor in a study will be similar to a different sponsor using the same EDC system. Feedback from sites suggests they had already been trained in the same EDC system for different sponsors.

Through this framework, TransCelerate has created a platform where both training vendors and sponsors can share the details of key content and concepts in the trainings they want to issue to sites. We are not asking EDC vendors or sponsors to provide trade secrets, but, rather asking whether their training covers key concepts, such as data entry, queries, sign off by investigators, and data verification (i.e., accurate representation). After sites have undergone training they typically receive a certification that provides key details such as the name of the training, the system and the version. Correspondingly, users can present that certification to TransCelerate member companies to avoid duplicative EDC system training.  

MA: Have you rolled out the EDC training framework yet? Where can sites access this information?

AC: The program went live in early June and we already have a number of training details on the TransCelerate webpage dedicated to this mutual recognition program. We have member companies and EDC vendors participating. They have registered their trainings, so that if another sponsor wants to have a user in the trial that says they have been trained by one of these participating TransCelerate member companies or EDC vendors they can look that training up and have some confidence that they have covered all the right areas. I would encourage any training providers to visit the TransCelerate website and add their training and review the FAQs. I would certainly encourage the readership who are training or about to be trained to talk to their trial sponsor about whether that training could be recognized by other sponsors in the future. The more companies and more training providers that participate, the more streamlined the training process becomes.