Mozersky et al. (2020). How do clinical research coordinators learn Good Clinical Practice?

• Aldwin Aldana, MS, RQAP-GLP, MRQA
  18/12/2020 17:13

  Knowledge on GCP isn't affected by the training being online vs. face-to-face, according to this study. What you do with the knowledge – putting it into practice – is the most important factor. https://hubs.li/H0C4Fnd0
• Juergen Kaetzler
  22/12/2020 16:43

  Thanks for this interesting information, Aldwin. We are having the discussion on remote vs. F2F-trainings for years now. Due to Covid-19 online trainings became more and more accepted - but prior to the Corona crisis Ethics Committees and even some sponsors did not accept online trainings although a knowledge test was included. So this is a good article to show and to ask "Why do you not accept an online GCP-training?"
• Colin Wilsher
  22/12/2020 17:50

  Even with a test, most people using online systems just click their way through it. In F2F people feel more able to ask questions and that us when you identify the elephant in the room. There are always those questions, sometimes nothing to do with the material presented, which open up a casum. F2F facilitates group working and group cohesion in the team. F2F allows the unexpected to happen. Online can be good with a lot if participation and live questions (webinar) but in F2F you see the fact that they don't really understand from their lack of engagement, and you can target those areas. F2F is more agile and people generally like it. Aldo there is the embarrassment factor. In F2F you have to be involbed to avoid the teacher and your fellow students seeing that you are actually not intersted or competent at GCP. that is worth a lot and there has never been an online course which could deliver that. Also managers like to get the team together to work together to cement their GCP understanding and commitment.
• Juergen Kaetzler
  23/12/2020 16:35

  I agree to the point that it is easier to communicate and to ask questions in F2F trainings. What I really like to do is to talk to the speaker(s) during the coffee breaks - no possibility to do that in online trainings. Nevertheless it depends on each participant if he/she gets involved or not. I had many (maybe to many) examples of trainings, where people were present because they had to do so... (e.g. GCP update required by Ethics Committee or internal SOPs). Those people showed no motivation in the F2F training nor were they active during the training - just sitting there, answering mails etc. They all passed the test at the end of the training. >> What I experienced is that if someone is required/forced to participate in a GCP training and has no internal motiviation, in most cases they will not show much engagement. On the other hand, if people are motivated and recognise the sense of the training they will benefit from an online training as well as from a F2F training and they actively participate. >> The German Federal Institute for Drugs and Medical Devices (BfArM) conduct the so-called "Ringvorlesungen" for students and interested persons. During the winter semester the lectures are being held online - and yes, there is less interaction during and after the lecture. Nevertheless, some people do ask questions and have some remarks but there are more discussions in F2F events.
• Colin Wilsher
  23/12/2020 18:42

  Embarrassment factor works strongly jn F2F gauche the trainer can target those doing their emails during training. No such sanction exists with onljne. I find it always works as they do t want to be shown up infront of their peers. Never happens online.
• Lyn Hampshire
  24/12/2020 11:38

  Having been involved in GCP training delivery for many years now I have found that whether the training is on-line or F2F the key to promoting understanding and engagement is through ensuring relevance and context. When the material is customised to the audience (e.g. Sponsor/CRO/Investigator/Off-site Research Nurse), and takes into account their level of previous experience in the clinical trials arena, then this helps to promote engagement and removes the barriers of expectations of a higher than reality baseline knowledge. Customisation would include demonstrating GCP application through examples of typical GCP-related tasks and activities. For the GCP training at investigator meetings, I have found that mapping the requirements of GCP to the specific details of the protocol really helps to highlight relevance, understanding and compliance.
• Juergen Kaetzler
  25/12/2020 14:45

  Lyn's point is crucial: when the GCP training is customised to the needs of the audience, acceptance is higher - irrelevant whether this is an online or F2F training (in my personal opinion). Unfortunately I have seen (and I still see) many, many standardised GCP trainings with no customisation. There is a requirement of some Ethics Committees in Germany that study personnel should attend a GCP refresher training at least every 3 years. Now imagine: every 3 years you have about 4 hours where you hear nothing new and only theory - no practical impact. This is one reason why I wrote that an online training is ont inferior to a F2F training. Colin pointed out that interaction is easier in F2F meetings. For me, it's a bit easier to ask a question via a chat function, but many others feel more comfortable to ask their questions "in person". Nevertheless, I have seen (too) many of those standardised GCP F2F trainings with >70 participants and not even a single question or interaction. Thus, I think that content (customisation) is more relevant than the actual type of training (F2F or online).

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