4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RECLIP - Spanish Pediatric Clinical Trials Network |
|
| Documented adherence to GCP guideline | Yes | All studies are conducted and monitored in compliance with local and national laws and regulations, including EU directive for clinical trials. All members of the network have experience in conducting GCP compliant studies and appropriate GCP training is regularly undertaken. Adherence to GCP and ethical consideration for clinical trials in children are clearly specified under the Item “D.6.2.1. General Responsibilities of the parties” of the Partnership Agreement, which has been duly signed by all the partners involved. As per ICH-GCP recommendations, all the study staff participating in RECLIP receives a proper training or refreshment on GCPs at least once every two/three years. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Provisions highlighted in the 'ethical considerations' document referred to be implemented in the design of all studies. The members of RECLIP respect the principles contained in the document "Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Pediatric Population - Recommendations of the Ad hoc Group for the Development of Guidelines for Directive 2001/20 / EC relating to good clinical practice In the conduct of clinical trials on medicinal products for human use "(EC, 2008). |
| Documented adherence to ethical considerations | Yes | All the research projects performed in the context of RECLIP are submitted to a qualify ethics committee before its implementation. |
| Availability of Standard Operating Procedures (SOP) | Yes | • Procedure of Recruitment of participants in a clinical trial • Informed Consent Procedure of the parents / guardians of the participants in a clinical trial • Procedure for assent of participants in a clinical trial • Eligibility and inclusion of participants in a clinical trial • Blood collection in participants in a clinical trial • Processing and preservation of samples in participants in a clinical trial • Blinding process in a clinical trial carried out in the • Data management • Procedure for detection and reporting of serious adverse events of participants in clinical trials • Staff training for the peformance of a clinical trial |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | For academic trials ICH GCP valid monitoring services are offered from the hub |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes | RECLIP hub verifies that activities are conducted with the highest level of quality and are completed on time, as agreed with the partners. |