4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PENTA - Fondazione Penta ETS - 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. |