4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Red SAMID - Spanish National Obstetric and Paediatric Research Network |
|
| Documented adherence to GCP guideline | Yes | we declare that all studies being conducted do comply with the EU directive 2001/20/EC on Clinical Trials |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Documented information is publicly available on our website about oour adherence to both, the ethical considerations for randomized clinical trial of the EMA (EMA/146065/2012) and to the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the WHO |
| Documented adherence to ethical considerations | Yes | |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Trial monitoring |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes | Specific standarised processes for Quality Control & Quality Assurance are available Data quality check is done at data entry, using a code, checking for missing values, outliers, discrepancies/incoherence to notify units. A random 5% of datasets is double-checked.. Traceability for both patient and unit identity is prevented by use of a unique coding system All data introduce in the database is secure by a double "servidor en espejo" get by SARENET (http://www.sarenet.es/SARENET/portada.htm) Unique code and encrypted databases, MIrrors servers are used |