European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management




PENTA - Fondazione Penta Onlus - Paediatric European Network for the Treatment of AIDS and Infectious Diseases

Documented adherence to GCP guideline Yes All PENTA-ID protocols are conducted in accordance with the principles of GCP. This is stated explicitly in the protocol and the SOPs at the trial management sites which have undergone satisfactory regulatory inspection.
Documented adherence to the ethical considerations for clinical trials in children Yes All protocols are reviewed and approved by central ethics committees specialising in paediatric studies.
Documented adherence to ethical considerations Yes There is a variation in local ethical committtee's ability to always have formal paediatric expertise available across Europe. PENTA-ID works with our local partners to request approval for independent ethical approval by a committee with paediatric expertise.
Availability of Standard Operating Procedures (SOP) Yes Formal SOP's are always available for each trial.
Capacity to monitor studies
(academic trials industry sponsored trials)
Yes All clinical sites are visited at least once during a study. The level of source data verification and site monitoring required for a study is determined in a risk assessment.
Capacity to monitor performance of collaborating centres Yes
Quality control and quality assurance, raceability and data safety Yes Trials units undertaking the data management of PENTA-ID trials have internal QA and QC procedures.