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
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.
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 (for commercial study sponsors):
- 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 following documents to the central commercial desk
- Contract set-up questionnaire
- Initial questionnaire GDPR
- Study protocol and flowchart
- Information and informed consent document
- Draft research contract
- Budget evaluation
- 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.
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
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 | Contact the commercial central desk for commercial clinical trials CTR conducted at Cliniques universitaires Saint-Luc. Please follow the procedure for managing clinical research contracts described above. Additional documents required as soon as they are available: Suitability of site, financial diclosure form for PI, declaration of PI for research team, no-fault insurance certificate, number of patients to be recruited at CUSL, initial questionnaire GDPR. |
| INVESTIGATIONAL DEVICE STUDY (DEVICE) MDR | - Flowchart to be consulted to determine the type of device and submission Contact the commercial central desk for commercial clinical investigations conducted at Cliniques universitaires Saint-Luc. |
| OTHER INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, acknowledgement of receipt, information sheet, invoicing form, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants. |
| NON-INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, acknowledgement of receipt, information sheet, invoicing form, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants. |
| RETROSPECTIVE STUDY | Simplified submission form, protocol, initial questionnaire GDPR, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, dated and signed CV (<3 years) of the principal investigator and co-investigators. As part of a retrospective study, 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
Related documents | |||
| Document 1 | |||
| Invoicing form | |||
| Acknowledgement of receipt | |||
| Contact information sheet | |||
| Simplified submission form | |||
| Declaration of conflict of interest form | |||
| No conflicts of interest for the research team | |||
| Summary of anti-corruption rules | |||
| External sponsor insurance form (if no insurance certificate) | |||
| GDPR - Initial Questionnaire | |||
| Suitability of site, pre-filled - Medical device (MDR/IVDR) | |||
| Suitability of site, pre-filled - Clinical trial (CTR) | |||
Informed consent | |||
| Informed consent for clinical trial with a medicinal product or device | English | French | Dutch |
| Informed consent for clinical research without medicinal product or device | English | French | Dutch |
| Informed consent for observational study | English | French | Dutch |
| Informed consent for incapable adults | English | French | Dutch |
| Informed consent for emergency situation | English | French | Dutch |
INITIAL SUBMISSION PROCEDURE
As soon as the site is selected and the study accepted by the principal investigator, the required documents are sent to the central commercial desk (guichetcommercial@saintluc.uclouvain.be). The commercial desk officer:
- Receives the documents and checks the submission file
- Analyzes the regulatory framework for the commercial study, based on its characteristics
- Collaborates with the pharmaceutical company/CRO to meet requirements
- Collects the necessary signatures
- Transfers the contract to the contracts and finance department, which reviews it in parallel with the submission.
Documents to be signed by investigators and/or the medical director: the external partner is advised to send them to the commercial desk as soon as possible in order to meet submission deadlines
Submissions to the hospital-faculty ethics committee: when the submission file is complete, the central commercial desk officer submits the study to the hospital-faculty ethics committee for review and approval, and informs the sponsor and investigator. A study submitted to the Ethics Committee by the commercial desk is considered as a complete and valid submission. The study is then placed on the agenda for the next meeting. Submissions are closed by the Ethics Committee on Wednesday for the meeting held 12 days later (every Monday).
The complete submission package must be sent at least 2 days before the desired submission date.
For submissions to the authorities: the commercial desk officer gets the Site Suitability form signed by the institution's legal representative (Medical Director) and by the PI for content validation. This signed document is returned to the sponsor once the commercial desk officer has received the documents required for regulatory assessment, RGPD and revision of the contract and budget (cfr required submission documents).
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).
COMPASSIONATE USE
When donating medicines for compassionate use, please send any agreement to the central commercial desk.
A « Data Processing Agreement » is required if medical data from the patient receiving the medication is sent to the pharmaceutical company providing the medication.
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).
Update : August 2024
