4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Irish Paediatric Clinical Research Network (IPCRN) National Children's Research Centre (NCRC) |
|
| Documented adherence to GCP guideline | Yes | All studies conducted will comply with the EU directive All paediatric investigators will receive GCP training |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Adherence to ethical considerations for clinical trials in children forms one of the core principals and objectives of IPCRN |
| Documented adherence to ethical considerations | Yes | All studies conducted will seek favourable ethical approval (and regulatroy approval, where appropriate) |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPs and various routemaps are available but they are not posted on the website |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Studies will be monitored by the National Children's Research Centre as per ICH GCP or by the Sponsor-appointed CRO |
| Capacity to monitor performance of collaborating centres | Yes | All investigators will regularly provide status reports to the National Children's Research Centre The National Children's Research Centre will act as the issue escalation point of contact, via the Clinical Research Project Manager |
| Quality control and quality assurance, raceability and data safety | Yes | QA/QC personnel may be hired in the future, pending funding; for the moment the Clinical Research Project Manager and Clinical Data Manger will oversee quality activitie and data safety |