European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

Newcastle-CCLG - Newcastle Children's Cancer and Leukaemia Pharmacology Studies Group

Existence of an identified contact person for external enquiries Yes
Existence of an internal steering committee No
Existence of an external advisory steering committee directing the reporting party Yes Data integrity and conduct of studies are monitored by Cancer Research UK, the wider CCLG professional body and an independent Data Safety and Ethics Monitoring Committee for specific clinical trials.
Existence of a website Yes https://cclg.arithmostech.com/
Existence of newsletter Yes An annual newsletter is published and made available through the group's website and via email. In addition, study specific newsletters are also published.
Existence of internal databases for disease, condition treatment and/or outcome Yes Database containing pharmacokinetic, pharmacodynamic and pharmacogenetic data.
Provisions to ascertain data protection and data security Yes Governed by UK National Health Service data protection regulations, the data protection act 1998 and the declaration of Helsinki.
Procedures to access the database by third parties No
Access to external databases/registries Yes Access to patient databases through the CCLG tissue bank and through the Birmingham clinical trials unit (CR-CTU).
Standardised process to access an external database Yes