CEIM

Regulations

National and European Legislation 

Autonomous regional legislation 

  • The 16 July 2009 Spanish Ministry of Health RESOLUTION regarding clinical trials and already-authorized observational studies on drugs and health products in the Autonomous Community of Valencia  (click to download – in Spanish) 

 

Requirements

Submission deadline: At minimum, the protocol, information sheet, informed consent, and researcher(s) commitment(s) should be provided before the 5th day of each month. The remaining documentation should be submitted by the 15th of the same month. 

The Evaluation Application should be presented by e-mail to the CEIC Administrative Secretariat at the Hospital Clínico Universitario in Valencia (CEIC-HCUV) (ceic_hcv@gva.es), and must be accompanied by the following documentation:

NOTE: The files contained in the e-mails/CDs must be named with a title that clearly identifies them, so that the recipients know which document is which without having to open the file (e.g. “Example protocol”, “Information sheet”, etc.).

 

Help: Classification of the study by the Spanish Agency for Medicines and Health Products (AEMPS).

In accordance with the Spanish Order SAS/3470/2009, of 16 December (which establishes the guidelines for post-authorization observational studies on drugs used in humans), for the agency to classify a study, the study’s promotor must submit the documentation for it to the following email address: farmacoepi@aemps.es

More information can be provided by AEMPS