4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PEDSTART - French national paediatric research network |
|
| Documented adherence to GCP guideline | Yes | All clinical trials that are conducted will comply with EU Directive 2001/20/EC, in conformity with French law Hurriet (n° 88-1138 du 20 décembre 1988) and the French law Jardé (n° 2012-300 du 5 mars 2012), but also all relevant and applicable regulations. Furthermore, all members are liable to pass the GCP test every 3 years and get a score above 80%. All CICs comply with the Quality Referential produced by the French Clinical Investigation Centres Network. All studies conducted strictly follow GCP guidelines. PEDSTART will set up a training program toward European research in paediatrics, first targeting CIC personnel and then extended to health professionals (in addition to existing programs already organized by the CIC members and associated universities.) |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | PEDSTART fully complies with current ethical considerations for clinical trials in children and participates in YPAG development through Kids France All clinical trials must obtain approval from ethics committee in France (CPP: comité de protection des personnes). PEDSTART will assist trials as required. |
| Documented adherence to ethical considerations | Yes | All trials are approved by an independent ethical committee and by the French Regulatory Authority (ANSM). Studies cannot be approved if they do not fulfill the national research requirements specific for children (law Jardé) |
| Availability of Standard Operating Procedures (SOP) | Yes | All CIC members of the PEDSTART network have their internal procedures (from study planning and preparation to study close-up and archive). It includes management of adverse events and serious adverse event according to national and European requirements. For the network coordination activities, PEDSTART has developed since 2019 a set of procedures that covers operational, management and quality aspects (such as documentation management, nonconformities management, change management, feasibility and capability assessment, steering committee management…) |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | PEDSTART network is usually not directly involved in site level trial monitoring. For industry and academic, trials monitoring is done by CIC dedicated staff members. The studies are monitored at least 3 times: - Beginning of the trial - End of the trials - After the first inclusion Monitoring of studies is performed by independent GCP trained personnel, according to GCP compliant SOPs. PEDSTART has recently developed a service with a CRO that can undertake monitoring n behalf the sponsor – this activity can also be done through the INSERM |
| Capacity to monitor performance of collaborating centres | Yes | PEDSTART aims to collaborate only with centers which follow good GCP. Each CIC has a qualified Staff available to help and train the investigators of collaborating centers. Moreover, performance is monitored according to SOPs in alignment with Quality System and control. The aim of the network is to show its added value implementing paediatric clinical researches at European level first in France and then at European level taking advantages of the c4c network. Within c4c, PEDSTART is also actively participating in the development of c4c sites standards, which will enable us to monitor performance of collaborating centres. |
| Quality control and quality assurance, raceability and data safety | Yes | PEDSTART, as task 2.7 lead within the c4c project, has developed a Quality framework for c4c network clinical trials. A similar approach has been undertaken for the PEDSTART network. A Quality policy is in place and annually reviewed with attached yearly quality objectives. An ISO-like QMS is being developed, focusing on customers’ needs, risk-based approach and continuous improvement. Plus, all CICs in the PEDSTART network work under the Quality assurance manual of the National Bureau of CICs (Manuel des Bonnes Pratiques Professionnelles des Centres d’Investigation Clinique, V2, Nov 2015), which standardizes the procedures used in pediatric clinical trials. |