WP01 GLOBAL PROJECT COORDINATION


 

Work Package Lead: Dr. Ruy López Ridaura

01. FUNDACION DE INVESTIGACION EN RED EN ENFERMEDADES CARDIOVASCULARES – FIRCAVA (ES)

 

Objectives:

  • Manage the global project and develop a program for institutional relations.
  • In coordination with WP2, develop the final study protocols and CRF.
  • Establish the whole clinical research plan and follow-up.
  • Organize a program for investigators' interaction and scientific interchange.
  • Ensure financial and legal issues as well as all responsibilities that have been committed in the GA and CA are fulfilled (i.e. allocation of funds between beneficiaries, reporting, SFCs, compliance of obligations and tasks, etc.).

 

Main tasks:

1. Project management and Institutional relations:

  • Negotiations with the EU for contract approval and signature
  • Negotiations with pharmaceutical companies for drug donation to the CT
  • Negotiation with ITAMAR for the endothelial Function measurement
  • Negotiation with Nationals Ethics Committee, and National Medicines agencies for trial approval and registration
  • Contract negotiation with insurance company for patient ́s insurance coverage
  • Registration of CT in public database ClinTRial.Gov and EUDRA
  • Financial and administrative management of the project (prepare annual scientific and economic 
report, prepare independent audits, and the final report).
  • Propose, prepare and coordinate baseline, intermediate and final scientific publications in 
collaboration with the SC

2. Prepare the final protocol in the CT format required to be submitted to the local/national ethic committees of all participating state member countries and monitoring for compliance with ethical standards throughout the project.

3. Prepare all needed material to be submitted to local and European medicine agencies for final approval of the clinical trial. 

4. Coordinate Interaction and scientific interchange among project investigators: Organization of scientific and periodic coordination meetings (different committees, the whole consortium, scientific meetings, monographic symposiums, training courses, interchange and training of young investigators among different partners).

 

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