School of clinical trials in practice

On 2. 4.- 4. 4. 2014 the PharmAround platform organised an event called ,,School of clinical trials in practice" in the hotel Medlov in Fryšava pod Žákovou horou.

This event was designed for investigators, study coordinators, study nurses and other persons interested in clinical trials.
 
When compiling the program we took into account our experience from the past PharmAround events as well as the feedback from the training course “Clinical Trial Coordinator“ organised by NCO NZO.  After sending a draft of the program, we saw that people were very interested and that their number even overweighted the capacity.  That  made us really happy. Our aim was to make the School of CT more interactive than the lectures and workshops usually are. We wanted to create such an environment which would allow the participants to be active and to have enough time for discussion. Therefore the capacity of the event was limited to 25-30 persons and the venue was chosen far from our workplaces.
 
After the introduction by Doctor Regina Demlová, all the participants presented themselves, their workplace, their position and all they are in charge of. It was very pleasant to see that the group comprised of study coordinators, ethics committees’ members, CT monitors, heads of the clinical trials departments at the university hospitals and more. Thanks to the participation of a colleague from Slovakia this event could bear the status „international“.
 
The first day was focused on academic clinical trials. We believe that our effort to explain terms as ECRIN/CZECRIN/ICRC and to present academic trials from the view of a research center wasn‘t vain. We hope that the participants got better idea of the activities of the academic intrastructures, whose objective is to support academic research in the Czech Republic. To meet the objective of the School we got down to more active program- work in small groups. We prepared a game to get to know each other. The participants made couples and each of them had one minute to present himself/herself and his/her job to the other one. At first they hardly knew what to talk about but then it was impossible to stop them. We fluently kept on discussing about the individual centers- about their structure, work organisation, types of clinical trials they carry out. A nice dinner with discussion put an end to the first successfull day.
 
During the second day we were speaking about the concrete work positions which appear in clinical trials and about their roles. We learnt about the obligations of sponsor and   investigator, about what to prepare before starting a clinical trial and about the agreements.
 
The morning was devoted to the lectures about monitoring, work of datamanager, person responsible for pharmacovigilance and laboratory worker. Those lectures were highly appreciated because sometimes it happens that the members of a team aren’t aware about obligations and workload of the others. Next we followed with the topic of audit and inspections. We went through the various kinds of controls and how to get well prepared for them. The end of the second day was again interactive. The participants formed groups whose task was to make a list of pros and cons of work in clinical trials. Although the groups were quite various, we found out that the problems are everywhere the same and what our jobs have in common is variability. 
 
It would be a sin not to profit from the lovely countryside surrounding us. Moreover the weather was good and we kept the timeschedule so we had time left to walk around or have a coffee and conversate.
During the second day we pursued many interesting topics forming a part of the GCP course e.g. CT documentation, CRF, source data and examples of most frequent mistakes in the source documentation. Having a GCP course in scope of the School of clinical trials  was considered a big bonus for all participants since everyone could leave with a GCP certificate. 
 
In the end each participant was given some small souvenirs- a T-shirt with logo and a CD with the lectures, but the most important things we gained were new business relationship and possibilities of cooperation.
 
Bc. Marianna Brabencová, 
Department of Pharmacology
Faculty of Medicine -Masaryk University