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Contract management

Overview

The subunit is responsible for the negotiation and execution of the Clinical Study agreements for all studies carried out in Bizkaia*, through communication with the involved parties (sponsors, principal investigators/collaborators, hospital departments, etc.).

The financial and administrative management of all clinical studies developed in Bizkaia will be carried out by the Clinical Study Contract Management Unit.

The Institute's researchers, platforms, and support units will participate as defined in the clinical study agreement.

The subunit supports the Site during the Sponsor´s feasibility assessment (feasibility form). The subunit coordinates the interaction among researcher and sponsor during the selection visits.

*Public Health Sites of Bizkaia: Basurto University Hospital, Cruces University Hospital, Galdakao-Usansolo University Hospital, Gorliz Hospital, San Eloy Hospital, Santa Marina Hospital, Urduliz Hospital and Bizkaia Mental Health Network.

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Contact email

Required Documentation

Required documentation to execute clinical trial agreements with medicinal products or clinical research agreements with medical devices:

  • Clinical Trial Protocol.
  • Regulatory authority approval (Spanish Agency for Medicines and Medical Devices (AEMPS) or CTIS)
  • Ethics Committee (CEIm) approval.
  • Insurance policy.
  • Financial report (if not included in the draft contract)
  • Copy of the signatory's power of attorney (if contracts have not been previously signed with the Institution)
  • Notarized delegation of responsibilities or power of attorney to sign on behalf of the sponsor (if the CRO signs on behalf of the sponsor).
  • List of participating centers in the Basque Country.

Required documentation to execute contracts for observational studies with medicinal products or Post-marketing studies with medical devices:

  • Study protocol.
  • Ethics Committee (CEIm) approval.
  • Financial report submitted to the CEIm.
  • Copy of the signatory's power of attorney.
  • Delegation of responsibilities (if signed by the CRO on behalf of the sponsor).
  • List of participating centers in the Basque Country.

Documentation required to execute clinical research project contracts:

  • Protocol/scientific report of the project.
  • Ethics Committee approval.
  • Financial report, if applicable.
  • Certificate of the insurance policy, if applicable.
  • Copy of the signatory's power of attorney on behalf of the sponsor. (or document certifying its signature).
  • List of participating centers in the Basque Country.

Members of the unit

Contact form - UIC EECC > Contract management

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