4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
NIHR CRN-Children - National Institute for Health Research Clinical Research Network-Children |
|
| Documented adherence to GCP guideline | Yes | All studies within the MCRN Portfolio are conducted in compliance with the EU Directive 2001/20/EC on Clinical Trials. The MCRN has access to a comprehensive GCP training programme which is open to all investigators working on MCRN Portfolio studies. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | MCRN Portfolio studies comply with national and international ethical and research governance requirements. |
| Documented adherence to ethical considerations | Yes | Studies within the MCRN Portfolio are required to comply with UK ethics requirements. |
| Availability of Standard Operating Procedures (SOP) | Yes | MCRN Local Research Networks and the MCRN Clinical Trials Unit operate according to SOPs |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | This is a core activity of the Clinical Trials Unit that work with the MCRN CC and LRNs/Areas to deliver studies. Other MCRN staff support activities on a case by case basis. |
| Capacity to monitor performance of collaborating centres | Yes | MCRN regional areas are closely performance monitored, with activity data reported to the MCRN Board and the Department of Health for England twice a year. Each MCRN Local Research Network is required to provide an annual report. |
| Quality control and quality assurance, raceability and data safety | Yes | This is a core activity of the Clinical Trials Unit that work with the MCRN CC and LRNs/Areas to deliver studies. Other MCRN staff support activities on a case by case basis. |