How to notify the CEIm 

All notifications and documents must be sent exclusively in digital format, preferably by email, to ceic@vhir.org, or via the Clinical Trial Management Portal of the Ministry of Health and Social Policy for clinical trials with drugs.
No documentation presented on paper will be accepted.

Proof of receipt

The CEIm will not issue proof of having received the documentation by email. If you need proof of receipt, request confirmation of receipt in the email you send.

Proof of receipt from the Clinical Trials Management Portal of the Ministry of Health and Social Policy site is in itself proof of receipt.

What must the CEIm receive?

The CEIm must receive:

• General notifications:
  • Approval from the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) [Spanish Drug and Medical Device Agency].
  • Initiation notification of the trial (the start date at the first centre in Spain and the date of inclusion of the first patient in Spain).
  • Annual trial follow-up report according to the model in Annex XI of the AEMPS instruction document.
  • Serious breaches, within the same notification timeframes for the AEMPS.
  • Update of the insurance policy.
  • Intermediate results report.
  • Stopping or interrupting recruitment.
  • Re-starting recruitment.
  • Ending recruitment.
  • Notice of the end of the trial in Spain (Annex 1D) and worldwide.
  • Final report or final results report.
  • Publication of results.
• Safety notifications:
  • Annual development safety update report (DSUR).
  • Suspected unexpected serious adverse reactions (SUSARs) that occurred in Spain where the outcome is death.
  • Any information or situation that may affect the benefit-risk balance of the study, through a specific communication intended for the CEIm.
  • Initial notification of urgent safety measures already adopted.
  • Data Monitoring Committee or independent data review committee notifications.
• Other notifications:
  • Change of the contact person who is the liaison with the CEIm at the Vall d'Hebron University Hospital.
  • Change of the Contract Research Organisation (CRO) or change of sponsor's name (which does not entail a legal change and, therefore, does not imply the presentation of a relevant amendment).
  • Extension of the recruitment period (which does not imply a relevant amendment). 
  • Increasing the number of patients (which does not involve relevant amendment). 

What should the CEIm not receive?

Refer to the summary of notifications that MUST NOT be sent to the CEIm here. 

• Approval from the Autonomous Community to which CEIm belongs.
• Start of the study at our centre: Date of first visit/opening at our centre and inclusion of the first patient at our centre.
• Annual follow-up reports.
• End date of the study at our centre.
• Final report (between three and six months after the study has ended).
• Study interruption communication, if applicable, and the reasons for it. 
• Relevant incidents (interruption of the study, serious safety issues, etc.) that can occur over the course of the study. The sponsor must report these to the CEIm immediately.
• Not-relevant amendments: It is only necessary to notify the amendments made, including a justification for the reason why these amendments do not affect the fundamental aspects of the study protocol.

The following should not be notified: 

• Notices corresponding to other centres or the lists of centres where the study is conducted.
• Any notification for an Observational Drug Study (ODS) where our CEIm was not the first CEIm to evaluate it.