Documentation
Templates and required documentation Clinical Trials/Studies

To speed the implementation of a Clinical Trial or an observational study, we offer the possibility of starting the processing of the agreement in parallel with the evaluation of the trial or study by the Medical Research Ethics Committee (ECRmp).
 
Generally, three copies of the agreement will be signed, except when otherwise expressly indicated. This documentation shall be sent to ensayosclinicos@idipaz.es  (care of Sara Moral Alamo) for negotiation and management.
 
 

ADMINISTRATIVE AND MANAGEMENT COSTS
  Clinical Trial Agreements €2000
  Observational Studies (PASS) Agreements €1500
   Observational Studies (NI-PASS) Agreements €1000
   Addendum to agreements €1000
 
 
 
For invoices corresponding to the items and quantities included in these agreements, please contact ensayosclinicos@idipaz.es.
 
 
 
   
TEMPLATES AND REQUIERED DOCUMENTATIO
  CLINICAL TRIALS
  Clinical Trial with Drugs Documentation
  Clinical Trial Medical Devices Template
Budget
Documentation
  POSTAUTHORISATION STUDIES
  Post-Authorization Safety Study (PASS) Drugs  Template Documentation
  Post-Authorization Safety Study (PASS) Medical Devices Template Documentation
  Non-Interventional Post-Authorization Safety Study (NI-PASS) Template Documentation
  ADDENDUM 
  General addendum Template
Budget
(*) You can download the  agreement models and necessary documentation clicking on the corresponding box.