Core Facilities

Clinical Trials and Studies (UCAICEC/UICEC-SCREN)

Mission

Serving society by promoting the health and well-being of citizens through the management of patient-oriented clinical research, both non-commercial and commercially driven, by means of continuous improvement, innovation and learning, fostering the professional and scientific development of all its members.

Description

It is a Research Support Service aimed at all Institute researchers who require support in the logistical, operational and regulatory design of clinical trials and observational studies. UCAICEC is conceived as a unit dedicated to promoting and supporting high-quality Clinical Research and Clinical Trials by providing comprehensive support to researchers in the planning, development, processing and execution of non-commercial research clinical trials and studies.

Among the activities carried out by UCAICEC is the management of SCREN at our centre. SCREN is a platform funded by the Carlos III Health Institute (ISCIII), with representation in more than 20 hospitals in Spain( https://www.scren.es).

Services offered

Advice on the conduct and execution of research projects:

  • Support in the management of documentation for evaluation by CEIC and Regulatory Authorities (AEMPS and CCAA).
  • Advice, management and support in the preparation and monitoring of the administrative documentation linked to the project.
  • Coordination and monitoring of approvals and study start-up (logistics and operations).
  • Advice on medication management and trial execution (CRO selection).
  • Advice on managing contracts with suppliers.

Monitoring (only for clinical trials managed by SCREN).

Technology

  • It has two computer systems and access to the FIBHGM’s shared printer, copier and scanner equipment.
  • Fireproof Cabinet
  • Documentation archive

Installation

UCAICEC is located in the Government Building (ground floor) and consists of an office.

Documentation guide for the ISO 9001: 2015 Unit

  • Procedure for the identification, processing and formalisation of commercial and non-commercial clinical trials (CTs) PR-IPE-02
  • IT criteria for the assessment of a non-commercial CT by FIBHGM as sponsor IT-IPE-01 IT authorisations   competent authorities IT-IPE-02
  • IT management of medicinal products IT-IPE-03
  • IT CRO budget IT-IPE-04 and CRO selection IT-IPE-04 IT management of contracting IT- IPE-06
  • CT (Clinical Trials) Monitoring Procedure PR-SPE-03
  • Procedure for identifying methodological support needs and preparing a work programme PR-AMI-01
  • Procedure for evaluating the methodological support work programme (CTs) PR-AMI-02

UCAICEC SAI Fees

Contact

María del C. de la Cruz Arguedas
Head of Unit
E-mail: ucaicec(ELIMINAR)@fibhgm.org
Government Pavilion (ground floor)
Gregorio Marañón General University Hospital
C/Dr. Esquerdo 46, 28007 Madrid