4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
BPCRN - Belgian Pediatric Clinical Research Network |
|
| Documented adherence to GCP guideline | Yes | All studies are conducted and monitored in compliance of all local and Belgian laws and regulations, including ICH-GCP, EU clinical trials directive, EU CTR, as well as EU Commission Ethics guideline. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All research activities involving children are assessed by an independent and competent ethics committee. BPCRN ascertains that research for children is maximally promoted while - at all times - adhering to all relevant ethical principles, as stipulated in the mission statement of the organisation. |
| Documented adherence to ethical considerations | Yes | Multiple experts from the network are involved in local ethic committees |
| Availability of Standard Operating Procedures (SOP) | Yes | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | We have direct contacts within our study sites and have reliable external partners for high quality ICH-GCP valid monitoring services upon request |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes | We adhere to all principles related to the framework for Good Research Practice as stipulated by our host institution (https://www.ugent.be/en/research/framework/overview.htm). As such, our Research Data Management (RDM) plan entails all actions needed to ensure that data are secure, easy to find, understand, and (re)use, not only during a research project, but also in the longer term (according to https://www.ugent.be/en/research/openscience/datamanagement) |