How do you train staff for whom there is no written requirement for GCP courses?

"We have to initiate 9 trial sites where there are nursing staff who have never had anything to do with clinical studies," my client explains to me. "What a lot of time goes into GCP training at each of the initiation visits! I could invest that time much better."

Yes, I do understand that. More and more studies we deal with involve staff who neither have to make medical decisions nor deal with all aspects of GCP. There is uncertainty on the part of our clients about what these people need to know about GCP. E6(R2) and also ISO 14155 require that sponsors and investigators use only qualified personnel. But how do I train an investigational medicinal product transport service, a home care nurse or home nursing staff sufficiently and at the same time efficiently on GCP?

During a discussion with the client, I came up with the idea of developing an interactive e-learning course that would efficiently introduce these staff to the most important aspects of clinical studies in a manageable amount of time - and without a seminar with compulsory attendance. During the meeting, I proposed this idea to my client and was overwhelmed by the extremely positive response! So, we got straight to work at the Forschungsdock Akademie and within a few weeks developed an e-learning specifically for this clientele. In 45-60 minutes, two likeable protagonists guide the learners through the key points of clinical studies: Manja and Luca are at the beginning of their professional careers and come into contact with the topic of clinical trials for the first time. They do research on the net, talk to an experienced investigator and also Luca’s aunt, who works as a clinical monitor. The learner deals with the topic interactively and can use a smartphone, tablet, or PC for this purpose - whenever and wherever it fits into the learner’s schedule. The e-learning concludes with a test and produces a certificate of participation upon successful completion.

Our client directly ordered 200 licenses for the e-learning. This training is now also available on the validated platform of the Forschungsdock Academie; perhaps this offer also closes a gap for your clinical studies? Feel free to contact us or click here for more information.

Author: Christoph Ortland, June 2022