Clinical Studies
Management Unit
Clinical Studies Management Unit
Unit
description
Unit
description
This unit manages and processes applications for clinical trials, observational studies and clinical research with medical devices.
Unit contact: estudios.clinicos@fisevi.com
0
New Clinical Studies contracts signed
* Data relating to the year 2023
0
Clinical Studies contract signature processing days
* Data relating to the year 2023
0
Active Clinical Studies
* Data relating to the year 2023
0
Active Clinical Studies in Early Phases (I-II)
* Data relating to the year 2023
Services
- Coordination and comprehensive management of the administrative procedures of clinical drug trials and other types of clinical trials.
- Management and processing of the suitability of facilities.
Management and processing of centre compliance.
- Support in the activities of the provincial Medicine Research Ethics Committee (MREC) of Seville and Research Ethics Committee (REC) at the Virgen Macarena – Virgen del Rocío and Sevilla Sur University Hospitals.
- Support for independent clinical research aimed at researchers in the logistical, operational and regulatory design of clinical trials and observational studies.
- Management, preparation and monitoring of financial contracts for clinical studies.
- Billing and financial monitoring of clinical studies.
- The provision of information to sponsors, researchers, committees, etc.
- The active search and acquisition of new proposals for clinical studies with sponsors and/or CROs
- Monitoring of updates to legislation, regulations and implementation procedures in the management of clinical trials, observational drug studies, clinical research with medical devices and research projects.
- Coordination and comprehensive management of the administrative procedures of clinical drug trials and other types of clinical trials.
- Management and processing of the suitability of facilities.
- Management and processing of centre compliance.
- Support in the activities of the provincial Medicine Research Ethics Committee (MREC) of Seville and Research Ethics Committee (REC) at the Virgen Macarena – Virgen del Rocío and Sevilla Sur University Hospitals.
- Support for independent clinical research aimed at researchers in the logistical, operational and regulatory design of clinical trials and observational studies.
- Management, preparation and monitoring of financial contracts for clinical studies.
- Billing and financial monitoring of clinical studies.
- The provision of information to sponsors, researchers, committees, etc.
- The active search and acquisition of new proposals for clinical studies with sponsors and/or CROs.
- Monitoring of updates to legislation, regulations and implementation procedures in the management of clinical trials, observational drug studies, clinical research with medical devices and research projects.
Servicios
FAQs
Contracts can be processed alongside committee and CTIS submissions and approvals.
The MREC meets approximately every 15 days. The REC meets once a month.
No, in Andalusia there are contract templates in place, published in the resolution of 13 June 2019 of the General Secretariat for Research. These templates are available from the documentation download area of the Clinical and Observational Trials Unit.
When the application to manage the suitability of the facilities is underway and alongside the relevant approvals.
No, the contract templates are public and cannot be modified or added to in any way.
No, the only contract template that can be signed is the public contract drawn up at the centre.
Electronic signature.
No, an annex cannot be modified once reviewed by the legal advisors of the Regional Ministry and published by it.
You can find this information in the documentation download area of the Clinical and Observational Trials Unit.
Please note that the amounts shown are subject to change according to the annual CPI.
No, neither the centre/foundation nor the service will be responsible for the management and processing of patients’ travel, subsistence and accommodation expenses.
Yes, the sponsor may hire the services of an external data entry vendor through an independent company for the sole purpose of completing the CRF (a task that, although carried out by the research team, is the responsibility of the sponsor as the data controller of the personal data contained in the CRF). This involves access solely and exclusively to pseudonymised personal data, at all times under the direct supervision and direction of the principal investigator of the study and in compliance with REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, repealing Directive 95/46/EC, and in compliance with Organic Law 3/2018 of 5 December on the Protection of Personal Data and Guarantee of Digital Rights. In no case may an external data entry partner be considered part of the research team of the study at the centre, nor may it carry out the functions related to said team.
