4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Newcastle-CCLG - Newcastle Children's Cancer and Leukaemia Pharmacology Studies Group |
|
| Documented adherence to GCP guideline | Yes | All members of the network have experience in conducting GCP compliant studies and appropriate GCP training is regularly undertaken. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Provisions highlighted in the 'ethical considerations' document referred to have been implemented in the design of a number of proposed and recently opened studies. Of particular relevance to the clinical pharmacology studies that we carry out is the issue of acceptable blood volumes and frequency of blood sampling. Indeed we have published studies designed to address this issue (Cole et al., 2006; Cole et al., 2007). |
| Documented adherence to ethical considerations | Yes | Ethical approval has been obtained for all studies. |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPs for study-related activities are posted on the study website. All other SOPS are stored within the document management system at the Northern Institute for Cancer Research, Newcastle University. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | All clinical centres participating in trials have been monitored by the group using an approach based on ICH 6 GCP Guidelines. |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes | Quality control and assurance procedures are in place. |