4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ITCC - Innovative Therapies for Children and Adolescents with Cancer |
|
| Documented adherence to GCP guideline | Yes | All clinical studies run within ITCC are conducted in compliance with the EU Regulation 536/2014 and with Good Clinical Practice. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All clinical studies run within ITCC are conducted by ITCC sponsors and have research ethics committees' approval. ITCC works closely with a patients' advocate network concerned with the ethical considerations for clinical trials. |
| Documented adherence to ethical considerations | Yes | Approval by an independent ethics committee is requested for all studies in the different participating member states, according to national laws. |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPs are available by the sponsors. ITCC Sponsor Network Committee have guidance documents available to the ITCC sponsors. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | On-site source data verification is performed by the institution in charge of a Academia-sponsored ITCC trial. Study monitoring of industry sponsored trial is performed by the Sponsor or outsourced to a CRO. |
| Capacity to monitor performance of collaborating centres | Yes | This is performed by the ITCC Sponsor Network Committee. In particular, number of patients per year and per center, as well as quality of data in academia sponsored trials are monitored. |
| Quality control and quality assurance, raceability and data safety | Yes | It is covered by the Sponsor according to the law. |