Looking Back: CLIN-Net and LAB-Net GCP Training, Sofia

On March 9th, CLIN-Net and LAB-Net in collaboration with the European Forum for Good Clinical Practice (EFGCP) organized its 5th face-to-face GCP training in Sofia, Bulgaria.

25 clinical and laboratory investigators from 8 different hospitals in Bulgaria  attended this year’s GCP training. Training expert Dr. Ingrid Klingmann¹ from EFGCP chaired the training. After an introduction of COMBACTE, CLIN-Net and LAB-Net, the investigators learned how GCP ensures the protection of trial participants and generation of reliable study results. Furthermore, the investigators received practical guidance on how to set-up a trial at their own investigator’s site to implement a protocol and to handle their responsibilities.

For the first time, a separate clinical and laboratory session was organized to discuss specific matters the investigators encounter in their own medical department. Dr. Klingmann showed the Bulgarian clinical investigators how to improve informed consent procedures and process adverse events. Dr. Annemarie van ‘t Veen² from LAB-Net gave the laboratory investigators insights in the quality guidelines on laboratory work and the GCP requirements for medical microbiology laboratories. The format of these sessions proved to be very successful, and it will be used in future face-to-face GCP trainings.

At the end of the day, the investigators were examined by means of a Transcelerate accredited test. The success rate for passing the test was a full 100%.

COMBACTE’s network in Bulgaria consists of 14 hospitals and 13 laboratories, out of which 11 hospitals have been selected to perform studies such as ASPIRE-ICU and the now-completed RESCUING study. The CLIN-Net and LAB-Net team last did their country visit to Bulgaria in September 2016. Previously held COMBACTE face-to-face GCP trainings were in Grindelwald, Madrid, Belgrade and Athens.

The next face-to-face GCP training course will be held on 14-15 of June 2017 in the Balkans, and will be organized for our COMBACTE investigators in Albania, Kosovo, Macedonia and Montenegro.

 

¹ Ingrid Klingmann (MD, PhD, FFPM, FBCPM, PHARMAPLEX bvba European Forum for Good Clinical Practice, Brussels (Belgium)) is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP). On behalf of EFGCP she was Work Package Leader of the PatientPartner Project and is currently Coordinator of the IMI project PharmaTrain. She is Work Package Leader of EUPATI, responsible for developing the EUPATI Network, the EUPATI National Platforms and the Ethics Panel. Dr. Klingmann chairs the clinical research module of the post-graduate Master in Regulatory Affairs course at the University of Bonn, Germany, and co-chairs the Diploma Course in Clinical Trial Practices at the University of Basel, Switzerland.

²Annemarie van ’t Veen (MD, PhD, MBA) works as a clinical microbiologist in the University Medical Centre in Utrecht, The Netherlands. She has been actively involved in building quality systems (ISO15189, GCP, Hospital Patient Safety program) in microbiology laboratories and hospitals in the Netherlands. Annemarie is member of the COMBACTE LAB-Net team and works on developing a quality assurance program in the LAB-Net network.