Commercial study
The central commercial desk is the only access point to the ethics committee (CEHF) for commercial studies; it is also the contact point for commercial sponsors.
CONTACT AND CONTACT DETAILS
The central commercial desk can be reached at: guichetcommercial@saintluc.uclouvain.be and 02/764.13.31 .
Organisation Management Service (OMS) registration number : Cliniques Universitaires Saint-Luc - ORG-100008950 - LOC-100014498
EORI number : BE0416885016
PEPPOL : Full Peppol participant ID : iso6523-actorid-upis∷0208:0416885016
CONFIDENTIALITY AGREEMENT (CDA)
When you propose a study to a PI, please put the commercial desk in copy of the email. If the PI is interested in the study, the commercial desk will review the CDA and handle the signatures.
INITIAL SUBMISSION PROCEDURE
Once the site has been selected and the study accepted by the principal investigator, the required documents are sent to the commercial desk (guichetcommercial@saintluc.uclouvain.be).
Submission to the authorities: the sponsor sends the required documents, along with the site suitability form completed and reviewed by the PI, to the central commercial desk. The commercial desk has the site suitability form signed by the legal representative of the institution (Medical Director) and by the PI to validate the content. This signed document is returned to the sponsor once the commercial desk has received the minimum required documents from the sponsor to process the file and review the contract and budget (see required submission documents).
The sponsor sends the required documents as quickly as possible in order to speed up the processing of the file and the review of the contract and budget. It is not necessary to wait for the documents to be validated by the authorities.
Submission to the hospital-faculty ethics committee: once the submission file is complete, the commercial desk submits the study to the hospital-faculty ethics committee for review and approval and informs the sponsor and investigator. Upon receipt, the Ethics Committee puts the study on the agenda for evaluation. Submissions are closed by the Ethics Committee on Wednesday for the meeting held 12 days later (every Monday). The sponsor must send the complete submission file to the central commercial office at least 2 days before the desired submission date.
PROCEDURE FOR MANAGING CLINICAL RESEARCH CONTRACTS
Clinical research contracts and the documents described below must be sent to the commercial desk, which then transfers them to the Contracts and Finance Unit (CoFi).
Procedure for submitting clinical research contracts:
- Read the Cliniques universitaires Saint-Luc requirements document and the price list of the different departments involved in clinical research
- Complete the « Contract set-up questionnaire » and Initial questionnaire GDPR.
- Send the documents listed in the table below to the commercial desk as soon as possible in order to speed up the processing of your application. It is not necessary to wait for the documents to be validated by the authorities. The contract will only be processed once the commercial desk has received the required documents.
- The central commercial desk then forwards all the documents to the contracts and finance unit, which will be responsible for revising the research contract.
Contract review time can be accelerated when a validated template is proposed.
- Either the commercial contract template validated by the Belgian academic hospitals and Pharma.be
- Either a master agreement already negotiated between the hospital and the sponsor
- Either a recent contract (< 1 year) already validated by the hospital
In other cases, please take into account the requirements mentioned in the document referred to in point 1.
SUBMISSION DOCUMENTS REQUIRED ACCORDING TO THE TYPE OF STUDY
To help you determine the type of study, the applicable legislation and the type of submission for your project, consult the clinical study flowchart.
TYPE OF STUDY | DOCUMENTS TO BE PROVIDED |
| INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) CTR | Documents required for sending the signed site suitability form: Study protocol (with flowchart), information and informed consent document, draft contract, and budget. The site suitability document must be completed by the sponsor and the PI. A pre-completed document is available in the table below. Additional documents required for review of the file: certificate of no-fault insurance, contract set-up questionnaire, number of patients expected at the CUSL, initial GDPR questionnaire. Documents to be obtained from the PI: conflict of interest declaration form, conflict declaration for the research team, dated and signed CV (<3 years) and GCP certificate (<3 years), PI and Head of Service signature page. The documents must be sent as quickly as possible to the central commercial desk in order to speed up the processing of the file and the review of the contract and budget. It is not necessary to wait for the documents to be validated by the authorities. |
| INVESTIGATIONAL DEVICE STUDY (DEVICE) MDR/IVDR | - Flowchart to be consulted to determine the type of device and submission Submission to the FAMHP:
The site suitability document must be completed by the sponsor and the PI. A pre-completed document is available in the table below.
The documents must be sent as quickly as possible to the central commercial office in order to speed up the processing of the file and the review of the contract and budget. It is not necessary to wait for the documents to be validated by the authorities. Submission to the CEHF: Provide the documents required for an interventional study and add: - If CE marked and within the indication: CE mark and device instructions - If no CE mark: Investigator brochure and FAMHP file Documents to be obtained from the PI: conflict of interest declaration form, conflict declaration for the research team, dated and signed CV (<3 years) and GCP certificate (<3 years), PI and Head of Service signature page. |
| OTHER INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, acknowledgement of receipt, information sheet, invoicing form, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants. To be obtained from the PI: conflict of interest declaration form, conflict of interest declaration for the research team, dated and signed CV (<3 years) and GCP certificate (<3 years) for PI and co-PI. |
| NON-INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, acknowledgement of receipt, information sheet, invoicing form, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants. To be obtained from the PI: conflict of interest declaration form, conflict of interest declaration for the research team, dated and signed CV (<3 years) and GCP certificate (<3 years) for PI and co-PI. |
| RETROSPECTIVE STUDY | Simplified submission form, protocol, initial questionnaire GDPR, draft contract and budget. To be obtained from the PI: conflict of interest declaration form, conflict of interest declaration for the research team, dated and signed CV (<3 years) from PI and co-PI. As part of a retrospective study, patient's consent is not necessary. Patients are informed of the use of their medical data via the information available on our website and the hospitalization notebook. |
TEMPLATES FOR SUBMISSION DOCUMENTS
COMMERCIAL CONTRACT TEMPLATE AND ASSOCIATED DOCUMENTS
- Contract template for commercial studies validated by the academic hospitals and Pharma.be.
- Transcelerate Site Profile Form.
- Electronic System Validation
- Computer system compliance with FDA21CFR Part 11
AMENDMENT AND STUDY FOLLOW-UP
The central commercial desk only handles initial study submissions.
Modifications and amendments are managed by the research team and forwarded directly to the hospital-faculty ethics committee by the research team, or to the authorities by the sponsor.
The research team is also responsible for clinical research follow-up and declarations to the hospital-faculty ethics committee (for studies initially submitted to the EC): annual reports for interventional studies, deviations, violations, unexpected events, SAEs with deaths, end-of-study notifications.
Documents related to the research follow-up are available on the Hospital-Faculty Ethics Committee website via this link (https://www.saintluc.be/fr/comite-d-ethique-investigation-clinique-suivi).
MONITORING OF STUDIES AT SAINT-LUC
Patient file access request procedure
Forms to complete:
- Confidentiality Agreement
- PI Authorization
- Identification Renewal
- Declaration of loss
CuSL policy regarding source data/medical record sharing:
Please take note that following the position of the Belgian Federal Agency for Medicines & Health Products (FAMHP), CuSL does not permit remote source data verification by external parties. As such, study teams are not permitted to remotely share (abstracts of) medical records with external parties. Exception is authorized for verification/adjudication of safety events.
Medical records cannot be shared outside CuSL in any other format, with the exception of pseudonymized radiology images, provided that this is described in the protocol & ICF, and as such approved by the Ethics Committee.
If a clinical research sponsor requires verification of medical data, than this can be done on-site. Alternatively, the pseudonymized data can be reviewed through data fields in the (e)CRF.
We appreciate you understand that as a hospital, CuSL has a responsibility and obligation to protect its patients right to privacy. Moreover, that the act of pseudonymizing records/reports involves a significant burden to our staff and carries an important risk of GDPR noncompliance/breach, which could result in significant fines for CuSL.
Any deviations from the above requires the explicit approval from CuSL's DPO and Medical Director. Questions can be submitted to the CTC (clinicaltrialcenter@saintluc.uclouvain.be).
COMPASSIONATE USE
When donating medicines for compassionate use, please send any agreement to the central commercial desk, with inform consent form and a description of the program.
A « Data Processing Agreement » is required if medical data from the patient receiving the medication is sent to the pharmaceutical company providing the medication.
Update : February 2026
