Clinical trials

Overview

This unit is responsible for negotiating and formalizing contracts for clinical studies carried out in the Balearic Islands, through communication with the various parties involved (sponsors, principal investigators, coordinators, participating services, etc.).

The economic and administrative management of all clinical studies conducted in the Balearic Islands will be handled by this same unit.

Each contract will define the participation of research teams, platforms, support units, collaborating services, etc.

Centers in the Balearic Islands:

  • Son Espases University Hospital
  • Son Llàtzer Hospital
  • Inca Regional Hospital
  • Manacor Hospital
  • Can Misses Hospital
  • Mateu Orfila General Hospital
  • and all Primary Care centers in the Balearic Islands.

Management of Facility Suitability

To initiate a clinical trial, it is necessary to request the signature of the facility suitability document by sending an email to IdISBa's Clinical Trials Unit (idisba.ensayos@idisba.es) with the basic study details (Code, EUDRACT, Principal Investigator, and Performing Service) and the following documentation:

  • Study Protocol
  • Synopsis in Spanish
  • General Financial Report
  • Completed Facility Suitability Form or AEMPS Annex IV

After receiving the request, the Clinical Trials Unit will process the signature of the document by the Center's Management.

The Clinical Trials Unit will send the signed document to the Sponsor or CRO at the requesting email address, and the contract and financial report management may begin.

Clinical Trial Contract Management

The sponsor must send the completed contract template, along with the necessary documentation for each type of study, to idisba.ensayos@idisba.es 

Required Documentation

For formalizing contracts for clinical trials with medicines/clinical research with medical devices:

  • Clinical Trial Protocol
  • Approval by AEMPS
  • Approval by the reference CEIm
  • Insurance policy
  • Financial report with detailed breakdown of visits and tests to be performed
  • Document delegating functions/responsibilities, notarized or power of attorney to sign on behalf of the sponsor (if the CRO signs on behalf of the sponsor)
  • Tax details for invoice issuance

For formalizing contracts for observational studies with medicines or post-marketing studies with medical devices:

  • Protocol
  • Favorable opinion from an accredited CEIm
  • Financial report submitted to CEIm
  • Document delegating responsibilities (if the CRO signs on behalf of the sponsor)
  • Tax details for invoice issuance

Facility Suitability Management (reminder)

To launch a clinical trial, it is necessary to request the signature of the facility suitability by sending an email to the IdISBa Clinical Trials Unit (idisba.ensayos@idisba.es) with the basic data of the study (Code, EUDRACT, Principal Investigator and Implementation Service) and the following documentation:

  1. Study Protocol
  2. Synopsis in Spanish
  3. General Economic Report
  4. Facility Suitability Model or Annex IV AEMPS completed

After receiving the application, the Clinical Trials Unit will process the signing of the document by the Center Management.
The Clinical Trials Unit will send the signed document to the Promoter or CRO to the applicant's email and the management of the contract and the financial report can begin.