CEIM

Clinical trials are defined by current legislation as any type of research in human beings to determine or verify the clinical, pharmacological, or pharmacodynamic effects of, detect adverse reactions to, or understand the pharmacokinetic characteristics of one or more medical products under investigation in order to determine their safety and/or effectiveness.

 

Regulations

Information on the National and European standards of clinical drug trials (web link – in Spanish). 

 

Requirements

Those promoting the clinical trials presented to the CEIC Secretariat at the Hospital Clínico Universitario in Valencia (CEIC-HCUV) must present the following documents by e-mail/on a CD (preferably by e-mail: ceic_hcv@gva.es):

Part I documents that must be sent to the AEMPS y the CEIm *

  1. Cover letter
  2. Application form
  3. Promoter consent, if applicable
  4. Protocol summary
  5. Protocol
  6. Investigator’s manual or data sheet for the drug under investigation
  7. Data sheet or investigator’s manual for any drugs not under investigation (auxiliary drugs)
  8. Scientific assessment and pediatric research plan

Note: All documents in Part I can be presented in English. However, the fields free of text on the application form should contain the information in both Spanish and English because the form will be registered on the Spanish clinical trials register. The protocol summary should be submitted in Spanish. 

Part II documents that must be sent only to the CEIm *

  1. Documents related to the proceedings and tools used for patient recruitment 
  2. Information destined for test subjects, informed consent form, and informed consent procedure
  3. Adequacy of the investigator (click to download – in Spanish) 
  4. Documentation to be forwarded by each center: 4.1 short form CV 4.2 Facilities suitability (click to download – in Spanish) 
  5. Proof of insurance coverage or financial guarantee
  6. Budget report
  7. Proof of CEIm fee payment, where appropriate

Note: The Part II documents, directed to the clinical trial subjects, mentioned in point 2 above, sent to the CEIm must be written exclusively in Castilian Spanish. Nonetheless, if requested, the clinical trial promoter will be responsible for providing an accurate translation of this information into other languages.

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.).

* Actualliced 09/08/2016