2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RECLIP - Spanish Pediatric Clinical Trials Network |
|
| Existence of an identified contact person for external enquiries | Yes | |
| Existence of an internal steering committee | Yes | Organization and Governance published in the web of RECLIP: http://reclip.org/organization/steering/ Steering committee • Leadership Body • Advisory Body • Management Body • Scientific Structure Executive committee • The General Coordinator of RECLIP, who acts as the Chairman of the EXECUTIVE COMMITTEE. • 4 clinical representatives of consolidated and/or thematic centres integrated in RECLIP, who will be elected by the STEERING COMMITTEE. • 3 representative of managerial organization (as default, 1 will be the managerial general coordinator). • Up to 2 representatives of the thematic networks that support scientific programs in RECLIP elected by vote by STEERING COMMITTEE. |
| Existence of an external advisory steering committee directing the reporting party | No | |
| Existence of a website | Yes | |
| Existence of newsletter | Yes | Newsletters of RECLIP are developed each 3 months and properly distributed via email to all the relevant members of the network and stakeholders involved (Public Institutions, private companies, etc.). |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | RECLIP has own internal Investigators Registry, which is closed and used only internally (i.e. all data is secured). Additionally, all trial requests, incl. sponsor information and detailed trial related information and documentation, is saved and compiled as statistics, which constitutes a RECLIP own statistical data base |
| Provisions to ascertain data protection and data security | Yes | RECLIP works under the ICH-GCPs principles as well as under the applicable local laws in force, LOPD (Spanish Organic Act on Data Protection) |
| Procedures to access the database by third parties | No | |
| Access to external databases/registries | Yes | Standardized processes in place at national level for access to relevant external national databases for research (same for network members as for other researchers). Not priviliged only for the network members. |
| Standardised process to access an external database | Yes | Standardized processes in place at national level for access to relevant external national databases for research (same for network members as for other researchers). |