Observational Studies

FundeSalud participation in observational studies

In the area of the Autonomous Community of Extremadura FUNDESALUD promotes relations between the Promoter, the Principal Investigator and the Extremadura Health Service subscription Contracts studies post-authorization observational according to the SAS / 3470/2009 Order, of 16 December. It also participates in the signing of contracts assuming the economic and administrative management of the funds for the realization of post-authorization observational studies.

Management Unit Clinical Trials Extremadura

Dedicated exclusively to the management of all activities related to clinical research, the Management Unit Clinical Trials Extremadura has among its main objectives promote translational clinical research, through a solid structure of support to researchers; encourage interaction and coordination between the different services of hospitals and research groups in order to promote new research projects with the highest possible quality and speed in their management; Translational boost clinical research projects and provide technical and administrative support to all research groups; clinical trials and attract industry to contribute to the promotion of clinical research in Extremadura, ensuring quick and quality management, an effective recruitment according to the study objectives and visibility to the transfer of results. Management Unit Clinical Trials is headquartered in the town of Mérida and has two offices that support the two provinces of the region.

Request completion of a post-authorization observational study

Under current legislation the trial sponsor, or CRO represent, must sign a contract with FundeSalud and Extremadura Health Service Models adjusting to Study contract established observational post-authorization:

• Model of post-authorization observational study contract signed by the Promoter

• Model of post-authorization observational study contract signed by the CRO

Once completed, or for any questions about it, you must send it to the address investigacionclinica@fundesalud.es.

Links of interest

Observational post-authorization studies with human medicines