4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
NETSTAP e.V. - Network of National Paediatricians in Germany |
|
| Documented adherence to GCP guideline | Yes | each member and participant center is regularly qualified by appropriate GCP certificate according to curriculum of BÄK (Bundesärztekammer) (current: Deutsches Ärzteblatt, Jg. 113, Heft 40, 7. Oktober 2016) |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | each member and participant center is regularly qualified by appropriate GCP certificate according to curriculum of BÄK (Bundesärztekammer) (Deutsches Ärzteblatt, 7. Oktober 2016, DOI: 10.3238/arztbl.2016.) |
| Documented adherence to ethical considerations | Yes | every study conducted by NETSTAP is performed with ethical approval. All these ethical commitees have to provide peadiatric expertise by German law. |
| Availability of Standard Operating Procedures (SOP) | Yes | we use SOP linked to respective studies, these SOPs are confidential |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | for small studies NETSTAP can provide an own qualified monitor. In large studies monitors are usually provided by sponsors |
| Capacity to monitor performance of collaborating centres | Yes | is possible but usually implemented by sponsor of industrial studies |
| Quality control and quality assurance, raceability and data safety | Yes | reporting party follows the rule of quality control according to ISO 9001:2015. Qualitiy manual exists including communication matrix and necessary process description. |