4 - Quality management
Quality
Management |
Training and
Education |
Public
Involvement |
Description | ||
---|---|---|
Name |
EPTRI (AISBL) - European Paediatric Translational Research Infrastructure (Association Internationale Sans But Lucrative) |
|
Documented adherence to GCP guideline | Yes | All documents related to adherence to clinical trial legislation and Good Clinical Practice (GCP) guideline are available from the EPTRI Members. |
Documented adherence to the ethical considerations for clinical trials in children | Yes | All documents related to the adherence to the ethical considerations for clinical trials are available from the EPTRI Members. |
Documented adherence to ethical considerations | Yes | EPTRI provides the paediatric community with advice on Paediatric Medicine Development Issues; advice on relevant Ethical, Legal and Societal Issues (ELSI) in a children/fundamental rights perspective (e.g. data protection, right to health protection…); advice on children empowerment and engagement in paediatric studies; easy dissemination of relevant information; documents and recommendations in the field of paediatric study methodology and ELSI. |
Availability of Standard Operating Procedures (SOP) | Yes | SOPs are available from the EPTRI Members. |
Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Monitoring and related SOPs are available from the EPTRI Members. |
Capacity to monitor performance of collaborating centres | Yes | Procedures and SOPs are available from the EPTRI Members. |
Quality control and quality assurance, raceability and data safety | Yes | Quality Assurance Processes and SOPs are available from the EPTRI Members. |