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Medidata on Avoiding the Pitfalls of EDC Training



By Deborah Borfitz

January 20, 2009 | By thinking globally and using the right blend of carefully timed training approaches, study sponsors and clinical research organizations (CROs) could more quickly realize the potential of electronic data capture (EDC), according to Paul MacDonald, senior business consultant for Medidata Solutions. This presumes EDC benefits are first understood by all levels of the organization and processes have been realigned to suit the technology.

Experience has repeatedly shown that companies relying on one training methodology—be they webinars or hands-on training—invariably run into difficulties as they scale up the number of EDC studies, says MacDonald. EDC trainees are not only geographically dispersed, with variable information technology skills, but undergoing a seismic shift in their roles and responsibilities.

Webinars are perhaps best suited to overviews of EDC for diverse audiences, to prime them for role- and EDC-specific training in an actual classroom or via self-paced e-learning, says MacDonald. Variable Internet connection speeds make webinars a largely unreliable approach for explaining the functionality of an EDC system in detail to end users, such as site personnel. “That can lead to a lot of confusion, especially on a global basis where English isn’t everyone’s first language.” It can also tie up training resources for an indeterminate length of time.

Investigator meetings are often used as a venue for training site personnel, says MacDonald. But it’s rarely the ideal setting. Some sites may not enter data until several months after the investigator meeting. “Recall becomes an issue. Companies are putting enormous effort into this…and then a lot of the message gets lost.”

When site training is conducted at investigator meetings or through webinars, it’s a “huge logistical issue” getting participants to sign training completion certificates, says MacDonald. “Extra training sessions are usually needed [because] training documentation is invariably incomplete.” Quality assurance audits almost always highlight “inadequate training documentation” as an issue.

“I favor e-learning because the message is consistent and an assessment can be included to prove [EDC users] know the basics,” says MacDonald. “Moreover, the training can be taken on demand. Companies can still follow up on this training, for example at site initiation visits.”

MacDonald says he routinely tells companies that without e-learning in place they may have to provide more training classes than they bargained for. They also need to plan for project team turnover with a “fall back strategy” for training new team members. He further warns companies to “adequately train people before giving them access to the system.”

Companies that use e-learning need to integrate training content with their EDC platform, says MacDonald. Rave, Medidata’s EDC system, allows users access to a study only upon passing an assessment of their assigned class. A certificate of completion can be printed at any time.

For more complex tasks, such as study build, a different approach is needed. In the past, most vendors sold “training days” without additional consultancy time to sponsors and CROs, says MacDonald. “They’d provide training, hand out some materials, and then say goodbye. It was up to [the client] to figure out how best to implement the system.” Today, “knowledge transfer” is the name of the game. Vendors take a more collaborative approach, handing off study build tasks in phases as the study build team gains the capabilities to do it on their own.

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