groups » Training and Career Development » The GCP Question

I would like for other to share their experiences with retraining participants on GCP and keeping them motivated and interested in the course.
The reason why I say is is because GCP is nteresting if it is done the first time and maybe but not alwyas the second time. During the subsequent training(s) it is just an oportunity to drink tea and take a break from work and participants rarely are attentive, after all it is just another GCP course. Keeping with the requirement that it is important for staff to be updated with GCP and that more than not they are likely to attend more than one GCP course, how do you keep them interested and looking forward to attending another session.


  • cdiaz cdiaz 11 Feb 2011

    Very good point all and good to have raised this. GCP is not difficult and there seems to be myth about who can trian. It is not necessary to have an expensive CRO. Someone with the right experience can train very well. It is probably the case that people do not have training as the belief is that external expensive training is needed. This myth needs removing so practical skills training on GCP can happen more often

  • atashili Julius Atashili 12 Jan 2011

    Dear Moses,
    Thanks for your thoughts and understanding of where I was going with that question. I find this to be a significant flaw in the system - similar to a medical licensing system in which there was no requirement for the licensing board. While allowing literally anyone to offer a GCP course (and certification in many cases) is expected to increase trainees, this seems to be at the expense of quality.This could be alleviated by having a formal training/certification for trainers or a system to rate the trainers.

  • mamulla Moses 12 Jan 2011

    Dear Atashili
    This is a very good question. Let me explain why and I really hope others comment because I think this raises a very key discussion. In my view and understanding there is no formal requirement to be a GCP trianer. To train people in GCP you need to have relevant and documented experience. GCP training is IMPORTANT but I really beleive that there is not enough training opportunities as people are under the misconception that you need to hire expensive professional trainers, or wait until your group is lucky enough to be invited onto a course being run by a drug company or product development group such as IAVI or MVI for some high quality training in a smart hotel.
    I know many groups who run their own in-house GCP courses - this is entirely acceptable and good practice. Of course you need experienced staff who are competant trainers and these trainers need to run courses with the right content, learning objectives and so on. This is perfectly acheivable to many sites. Especially where trial staff are highly experience and live GCP day to day. So please others share you thoughts. My position is that there is a like of training as groups think they cannot do this themselves when they can and should! Let us support this through this platform

  • atashili Julius Atashili 12 Jan 2011

    Is anyone aware of a formal training for GCP trainers?

  • reginalice Regina Wangnapi 26 Aug 2010

    It is wise to have one person from a clinical trial attend a GCP course and then this person has the responsibility of training the rest of the group, which includes any new employee and that would cut down on cost. From experience attending one course as a new recruit into research would require you to do alot of reading whilst attending a GCP workshop hence you forget some very important things but if you have worked in a clinical trial and had some form of training with GCP, then you understand things better at a GCP course and will not require a second course but a refresher at your own institution. Another idea would be to have one part of GCP talked about or discussed in a forthnightly or monthly staff meeting. The Vienna School of Clinical research provides one of the best GCP training, which would be enough for only one person to be well equipped to teach or train any new employees into a research institution or give refresher courses to colleagues.

  • Nanfuka Rehma Nanfuka Kisakye 25 Aug 2010


    I totally agree with Moses's post above, especcially on fact that it is rarely necessary to spend alot of money on commercial training course. That is why I also believe that we should train trainers from our regions / countries / institutions to give GCP and other necessary trainings whenever required, at low cost.

  • mamulla Moses 25 Aug 2010

    Hello All,
    I think the plan is to add GCP training onto this site once it is fully launced and built. It would be good to have access to free training that we could use for our research teams and also as refresher training. The training page of this website say's that is the plan. The good thing about this training when it comes is that it will not be for once specific countries to meet their local requirement, but broadly applicable to all. I agree with the comment above that there is no specific time frame within ICH-GCP and many countries set their own recommendations - although in our regions most do not have any such requirement and so we have the advantage of being able to apply common sense and take responsibility for keeping our teams training up to standard. It is not necessary often to spend a high amount of money on commerically run training courses.

  • peterw peterw 24 Aug 2010

    I think the refresher training is a country specific requirement and I though in the uk it was 18 monts, not 2 years, but couldn't be sure. See if the following helps,

  • phaikyeong phaikyeong 6 Jul 2010

    Yes, indeed it is quite UK centric but the principles apply. Are you affiliated to any univeristy in the UK? Oxford University allows all collaborators to use their account whereever they may be. A lot of UK institutions subsribe to it e.g. Cambridge, Imperial College.

  • DavelineNyakundi Daveline Nyakundi 6 Jul 2010

    following up on what Moses has mentioned, could someone point out the standard/policy or guidelines behind the 2 year span recommendation to have refresher GCP. As much as i see the logic it, i would like know where to get that (in citation)

  • mamulla Moses 6 Jul 2010

    The other point is that as far as I know it does not say anywhere in ICH-GCP that there needs to be refresher courses every 2 years... perhaps that is a way for the commercial organisations that run the training to keep the money coming in? We recently set up a trial and retrained our staff on GCP in an protocol specific way - so made it entirely related to the study procedures and referred to which element of GCP we were discussing at each stage. So for example when we trained the nurses taking consent about the form and the SOP we reminded them about the GCP requirements for consents, same with the session we ran on study documentation, investigational product and all the SOP training. My recommendation is to make GCP part of the overall study training for every new protocol. This keeps the staff enthused and makes it relevant. No one has to have a shiney new certificate and a week in an expensive hotel!!!!

  • mamulla Moses 6 Jul 2010

    Hi Thanks Phaik Yeong, does that site need a password, can anyone register?

    It does look good although is it focussed on running trials in the UK? We need a free and online course that is designed especially for working outside of Europe and the US - any ideas anyone?

  • phaikyeong phaikyeong 5 Jul 2010

    Check out this online course. It is available in 5 modules, so one only needs to complete the relevant modules, especially if its for refreshers. See this link -

  • gogetii Gilbert Ogetii 5 Jul 2010

    Hi, we recently had a refresher training and the course was task based with planned group activities and i thought it was a good way of keeping the participants interested and attentive. Another aspect was bringing up current issues/debates in GCP and related guidelines.

    True, there is need for innovative ways to make GCP training courses interesting and relevant to those already well versed with the guidelines.

  • Dapollo Dapollo 5 Jul 2010

    In teaching especialy adults,trainers have to involve the particpants actively inorder not to let their minds wonder. Usualy, these are people who are occupied with other issues other than work. Long hours of sitting listening to a speech may not be very well accomodated. Practical sessions may also help

  • swandiga Steve Wandiga 5 Jul 2010

    The idea about re-certification after 2 years in Good Clinical Practice (GCP) is to refresh the memories of participants on the content given that there is a waning away of concepts and importance of GCP. One of the approaches that may be used is short group activities - filling of acronyms that are GCP related.., allow for experiential application of GCP e.g, informed consent process.., good documentation practices etc.

    They need to have a hands-on experience in the second GCP training when compared to the first time.

    If this is done, then the feeling that it is time off duty or opportunity to take snacks/tea will not arise.

    Finally, trainers need to have back-up measures for delivering content if an approach seems not to interest the audience (how else can it be relayed to the participants as opposed to the norm!!)

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