5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PEDSTART - French national paediatric research network |
|
| Evidence of collaboration with regulatory authorities | Yes | F-CRIN is member of the CNAFPEC (National Council for the Performance of Clinical Trials). Behrouz Kassai (from RIPPS and Lyon’s Clinical Investigation Center) is a member of the French Pediatrics Investigation Plan workgroup and a member of the ANSM’s (National Agency for the Safety of Medicines and Health Products) Pediatric Steering Committee. An ANSM representative is invited on a regular basis and as frequently as needed to PEDSTART Steering Committee. |
| Capacity to provide competent consultation to regulatory authorities | Yes | Several members of PEDSTART are part of an ANSM scientific committee. Like Jean-Marc Treluyer, an expert in pharmacology. There is also Behrouz Kassai and Segolene Gaillard who are members of one of the 39 French Committees of Protection of Persons (Comités de Protection des Personnes, CPP). They are affiliated to the "CPP Sud Est II" branch. |
| Formal meetings for clinical trials | Yes | Throughout a specific trial, different types of formal meetings (Clinical Trial Meeting, Advisory Board, Investigator Meeting, KOL, Trial Management Group, Trial Training…) take place depending on what stage the trial is at. Among other things, these meetings offer an opportunity for attendees to re-train and receive trial updates, learn from each other, share best practice and troubleshoot issues. These meetings play a key role in bringing stakeholders together. Example: TMG for TREOCAPA : 1 per month, regular meeting for KD-CAAP trial |
| Training courses given over the last 2 years | Yes | 32 training courses. Please find attached a list of organized training courses. Via the conect4children Academy learning platform, PEDSTART is able to provide educational tools and training materials specifically tailored to the needs of its network and all those involved in the conduct of pediatric clinical trials. In addition, all Clinical Trial Investigation Centers (CIC), regularly organize training sessions for their investigators and clinical trial teams. Some PEDSTART members have extensive clinical research teaching experience. |
| Training courses received over the last 2 years | Yes | Please find attached a list of network-wide training courses received. In addition, all Clinical Trial Investigation Centers (CIC) staff are GCP trained and they have access to training courses and conferences adapted to their training needs and/or regarding specific trials. The GCP training is not explicitly stated in the SOP since all members conduct clinical research at their respective institutions and GCP training is mandatory for conducting research. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | None as of yet. |
| List of Countries |