Monitoring and Regulating Program

About MRP

The MRP is a fundamental backbone of the Platform for the Clinical Research and Clinical Trials Unit (SCReN).

The MRP encompasses all the UICECs, in a genuine network structure, possessing the capacity to provide essential support services for the design, planning and implementation of Clinical Research projects.

Services

Pre-start
  • Study feasibility
  • Preparation of the Spanish Agency of Medicines and Medical Devices (AEMPS) clinical trial application
  • Preparation of the specific IMP documentation (IMP, import, distribution or packaging)
  • Preparation of the local clinical trial application documentation to Medical Research Ethics Committee (CeiM)
  • Preparation and conduct of meetings for investigators
  • Processing the application for civil liability insurance policies
  • Elaborating the investigators file
  • Elaborating the sponsor's file
  • Responding to clarifications required by the Medical Research Ethics Committee (CeiM)
  • Responding to rectifications or clarification required by Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Clinical trial registration and periodic maintenance
  • Obtaining approval from directorates
  • Managing site contracts
  • Preparation of the monitoring plan
Study development
  • Project management
  • Start-up notification to Spanish Agency of Medicines and Medical Devices (AEMPS) and the Medical Research Ethics Committee (CeiM)
  • Preparation, development and report of the initial site visit
  • File maintenance
  • "On-line" monitoring (Web-based)
  • Telephone monitoring
  • Preparation, development and reports of the periodic monitoring visits
  • Newsletters
  • Preparation and conduct of meetings for investigators
  • Preparation and conduct of teleconference
  • Preparation of protocol amendment documentation
  • Preparation of site inclusion amendment documentation
  • Dispatch of application amendment to Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Dispatch of amendment application to the Medical Research Ethics Committee (CeiM)
  • Economic and administrative management of payments
  • Control and management of biological samples
  • Control and management of additional tests (PK, imaging, etc.)
  • Control and management of study medication shipments
  • Drafting annual study reports for Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Drafting annual study reports for the Medical Research Ethics Committee (CeiM)
Completion and close-out
  • Preparation, development and report of the close-out visit
  • Resolution of queries and database lock
  • Pharmacy close-out visit (samples accounting and reconciliation)
  • Close-out notification to Spanish Agency of Medicines and Medical Devices (AEMPS) and the Medical Research Ethics Committee (CeiM)
  • Drafting the final study report
  • Publication of the results (medical writing)

Functional Organization

SCReN centres

29 support units to conduct research (UICECs) integrated into the NHS care centres distributed in 11 autonomous communities.

Click on an Autonomous Region for more information: