Introduction
As an academic hospital, the Cliniques universitaires Saint-Luc (CUSL) provide activities as diverse as teaching, patient care and the continued development of research.
The Cliniques universitaires Saint-Luc focus their research strategy on many areas of activity, in a wide variety of medical disciplines. More than fifty departments and centers are involved in research activities, in close collaboration with the IREC research poles.
The Cliniques universitaires Saint-Luc and the Ethics Committee (Comité d'Ethique Hospitalo- Facultaire Saint-Luc-UCL) have had the full AAHRPP (Association for the Accreditation of Human Research Protection Programs) accreditation since September 17, 2015. This accreditation is a quality label and the recognition that the hospital follows the standards of ethics and quality in managing its clinical research activities. It covers processes and procedures, organizational management and patient protection. It ensures the best guarantee of protection for patients participating in clinical trials.
In 2014, the increasing complexity of clinical studies and their legal framework as well as the prospect of clinical research accreditation led the CUSL to create a centralized management structure for clinical research: the Clinical Trial Center (CTC - clinicaltrialcenter-saintluc@uclouvain.be).
Mission
The mission of the CTC is to professionalize clinical research in the institution and to cover all dimensions of commercial and academic research from an economic and organizational perspective.
Vision
- Become a center of excellence
- Create a centralized structure
- Become a differentiating and attractive element
- Be an incentive for higher quality clinical research
Objectives of the Clinical Trial Center
The operational support provided by the CTC to the Clinicians and Clinical Researchers of the CUSL is provided through the following approaches :
- Support for setting up academic and commercial studies axis: central desks
The academic central desk (guichetacademique-saintluc@uclouvain.be) is responsible for providing regulatory and administrative support for submissions to the Ethics Committee (CEHF) and for implementing academic studies carried out at the CUSL, in order to coach investigators and study coordinators in charge of academic studies.
The commercial central desk (guichetcommercial-saintluc@uclouvain.be) is the point of entry and institutional support for the initial submission to the CEHF of files relating to clinical studies.
- Financial axis
Among other responsibilities, the "Contracts, Finance and Reporting" unit of the CTC (CoFi) manages commercial and non-commercial clinical research contracts and provides support for financial management such as participating in the centralized invoicing process, analyzing the balance sheet and approving expenditures related to clinical research.
Before submitting to calls for European or regional projects involving the CUSL, it is imperative to contact the CoFi (contractsfinancesCTC-saintluc@uclouvain.be) when drawing up the budget in order to estimate the necessary resources and align the budget accordingly.
- Human resources axis
The study coordinator operational support is responsible for coordinating the recruitment and training of the institution's study coordinators. Requests for temporary staff are directed to an interim company.
- Quality and regulatory affairs axis
The CTC provides a continuous regulatory watch which ensures that the quality system governing clinical studies is adequate.
The CUSL have a high quality system that updates and shares the procedures governing clinical research. These procedures are available via the website (https://www.saintluc.be/recherche/ctc-accueil.php) and intranet.
Research staff benefit from ongoing training tailored to audit results and external evaluations.
- Information management and reporting axis
The development of academic indicators and the collection of the data required to obtain B7 funding, reducing the professional tax on researchers and the UCL-Saint-Luc convention are part of a team effort between the CTC and the Financial Department.
- Networking axis
The CTC participates in various working groups and establishes privileged contacts with the regulatory authorities, the KCE, the Belgian academic CTCs and the pharmaceutical industry.
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