4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
UKPVG - United Kingdom Paediatric Vaccine Group |
|
| Documented adherence to GCP guideline | Yes | Prerequisite for any clinical trial and monitored by Sponsor relevant to each study. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Prerequisite for any clinical trial involving children and monitored by Sponsor relevant to each study. In the UK all ethics committees are required under the Clinical Trials Regulations to have advice from a member with professional expertise in paediatric care for studies involving children (see http://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures/ ). |
| Documented adherence to ethical considerations | Yes | Prerequisite for all studies. |
| Availability of Standard Operating Procedures (SOP) | Yes | All sites have own SOPs, often standardised across all sites. No external links available. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Monitored by relevant Sponsor for each study. For non-industry sponsored studies monitoring is performed by representatives of the lead site, and is facilitated by use of electronic clinical trial databases. |
| Capacity to monitor performance of collaborating centres | Yes | Monitored by lead centre for each study, with regular (up to weekly) teleconferences between UKPVG members to review performance and discuss any concerns. |
| Quality control and quality assurance, raceability and data safety | Yes | Monitored by relevant Sponsor for each study, with a designated quality assurance lead for each non-industry sponsored study. |