Academic study
The central academic desk is the only access point to the ethics committee (CEHF) for academic studies (CUSL or external sponsor). It is also the contact point for sponsors, investigators and research coordinators for the initial submission of academic studies.
CONTACT DETAILS
The central academic desk can be reached at : guichetacademique@saintluc.uclouvain.be and 02/764.17.44 .
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
INITIAL SUBMISSION PROCEDURE
External academic sponsor study:
- When the sponsor has at least a research protocol, an information and consent document, and a budget estimate, they contact the central academic desk by email with the documents attached (guichetacademique@saintluc.uclouvain.be).
- The academic desk will send an email acknowledging receipt and will read the documents received.
- The study is created in the Claire software so that the investigator at the Saint-Luc University Clinics can monitor the progress of the file via tracking indicators
- The academic desk performs a preliminary analysis of the documents and assesses the regulatory and financial feasibility of the project (based on the PI's financial statement).
- In the case of a submission to the authorities, the sponsor sends the required documents, as well as the site suitability form completed and reviewed by the PI, to the academic desk. The academic 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 academic desk has received the minimum required documents from the sponsor to process the file and review the contract (see required submission documents). The sponsor sends the required documents as quickly as possible in order to speed up the processing of the file. It is not necessary to wait for the documents to be validated by the authorities.
- The academic desk forwards the file to the Contracts and Finance Unit in the case of a multicenter study or requests financial approval from the head of the Contracts and Finance Unit in the case of a single-center study promoted by CUSL. If necessary, it informs the principal investigator of the agreements to be made with the institution's partner services.
- The academic desk submits the file to the hospital-faculty ethics committee when it is complete and in order from a regulatory/financial standpoint.
CUSL sponsor study:
In addition to the steps mentioned above, the academic desk completes the insurance application and directs the sponsor to the Statistical Support Unit to create a project in REDCAP.
If the study involves a drug or medical device, the academic desk:
- assists the CUSL investigator-sponsor in preparing the submission file
- conducts, together with the investigator-sponsor, a more detailed feasibility assessment, including an evaluation of the risks of the project
- submits the file to the competent authorities and follows up on it until it is approved
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 EXTERNAL SPONSOR | Documents required for sending the signed site suitability form: Study protocol, informed consent forms, draft contract. The site suitability document must be completed by the sponsor and the principal investigator. A pre-completed document is available in the table below. Additional documents required for review of the file : Certificate of no fault insurance, 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), academic sponsor financial declaration (completed by the PI), PI and Head of Service signature page. The documents must be sent as quickly as possible to the academic desk in order to speed up the processing of the file and the review of the contract. It is not necessary to wait for the documents to be validated by the authorities. |
| INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) - CTR CUSL SPONSOR | Contact the academic central desk and provide the following documents: Clinical Trial Protocol, Financial Reporting CUSL Sponsor, Drug Supply Arrangements, Planned Number of Patients (site breakdown), Initial RGPD Questionnaire, PI and Head of Service signature page. The academic desk officer will help you to prepare the submission package after assessing the feasibility of your project. |
| INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR/IVDR EXTERNAL SPONSOR | - 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 academic desk in order to speed up the processing of the file and the review of the contract. It is not necessary to wait for the documents to be validated by the authorities. Submission to the CEHF: Provide the documents specified in the study design (interventional, non-interventional, retrospective, or MCHr) and add: - If CE marked and indicated: CE mark and device instructions - If not CE marked: 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), academic sponsor financial declaration (completed by the PI), PI and Head of Service signature page. |
| INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR/IVDR CUSL SPONSOR | Contact the academic central desk and provide the following documents: Clinical Trial Protocol, Financial Reporting CUSL Sponsor, Device Supply Arrangements, Planned Number of Patients (site breakdown), Initial RGPD Questionnaire, PI and Head of Service signature page. The academic desk officer will help you to determine the submission type required and to prepare the submission package after assessing the feasibility of your project. |
| OTHER INTERVENTIONAL STUDY | External sponsor: Protocol, summary in French (1 page), document 1, initial GDPR questionnaire, consent, acknowledgement of receipt, CRF, certificate of insurance, draft contract, any other documents intended for the patient (questionnaire, diary, scale, ...) in the language of the participants. To be obtained from the PI: Dated and signed CV (<3 years) and GCP certificate (<3 years) of PI and co-PIs, academic sponsor financial statement (completed by PI). CuSL sponsor: Protocol, summary in French (1 page), document 1, initial GDPR questionnaire, consent, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (<3 years) of principal investigator and co-investigators, CUSL sponsor financial declaration, any other patient documents (questionnaire, diary, scale, etc.) in the language of the participants, database used. |
| NON-INTERVENTIONAL STUDY | External sponsor: Protocol, summary in French (1 page), document 1, initial GDPR questionnaire, consent, acknowledgement of receipt, CRF, certificate of insurance, draft contract, any other documents intended for the patient (questionnaire, diary, scale, ...) in the language of the participants. To be obtained from the PI: Dated and signed CV (<3 years) and GCP certificate (<3 years) of PI and co-PIs, academic sponsor financial statement (completed by PI). CuSL sponsor: Protocol, summary in French (1 page), document 1, initial GDPR questionnaire, consent, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (<3 years) of principal investigator and co-investigators, CUSL sponsor financial declaration, any other patient documents (questionnaire, diary, scale, etc.) in the language of the participants, database used. Request for insurance certificates is done by the academic desk. |
| REGISTRY | External manager: Protocol, Simplified submission form, Initial questionnaire GDPR, Draft contract DTA, Database used. To be obtained from the PI: Dated and signed CV (<3 years) of PI and co-PIs, Academic sponsor financial declaration (completed by PI). CuSL manager: Protocol, Simplified submission form, Initial GDPR questionnaire, Database used, Dated and signed CV (<3 years) of PI and co-PIs, CuSL sponsor financial declaration. Monocentric CUSL registries do not need to be submitted to the EC and are not recorded in Claire, as they are department-specific databases kept internally. Legal registries (cancer registry, etc.) do not need to be submitted to the EC. Participant consent: in the context of a registry, the patient's consent is not necessary, patients must only be informed about the use of their medical data.
|
| RETROSPECTIVE STUDY | External sponsor: Simplified submission form, Protocol, initial GDPR questionnaire, draft contract, CRF. To be obtained from PI: Dated and signed CV (<3 years) of PI and co-PIs, academic sponsor financial declaration (completed by PI). CuSL sponsor: Simplified submission form, Protocol, initial GDPR questionnaire, dated and signed CV (<3 years old) of PI and co-PIs, CuSL sponsor financial declaration, database used. Participant consent : In the context of a retrospective study, patient's consent is not necessary, patients must only be informed of the use of their medical data.
|
| HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA (RESIDUAL or SECONDARY USE) | External sponsor: Simplified submission form, research description letter, draft contract (MTA). To be obtained from PI: Dated and signed CV (<3 years) and GCP certificate (<3 years) of PI and co-PIs, academic sponsor financial declaration (completed by PI). CuSL sponsor: Simplified submission form, research description letter, dated and signed CV (<3 years) and GCP certificate (<3 years) of PI and co-PIs, CuSL sponsor financial declaration. |
TEMPLATES FOR SUBMISSION DOCUMENTS
TEMPLATES FOR ACADEMIC CONTRACTS AND ASSOCIATED DOCUMENTS
- Template of academic contract validated by academic hospitals
- Template of academic contract for non drug trials validated by academic hospitals
- CUSL/UCL Clinical Study Contract
- Material Transfer Agreement
- Material Transfer Agreement CUSL/UCL
- Data Transfer Agreement
- CUSL/UCL service provision contract
- SIP Facility Profile Form.
- Electronic System Validation
- Computer system compliance with FDA21CFR Part 11
- EPIC ONC certification
AMENDMENT AND STUDY FOLLOW-UP
In the case of a study involving a drug or a medical device for which Cliniques universitaires Saint-Luc is the sponsor, the central academic desk is responsible for submitting modifications and amendments to the competent authorities, as well as for the follow-up of the clinical research: annual report (ASR), SUSAR, deviations, violations, unexpected events, SAE with death, and end-of-study notifications.
For other types of studies, the academic central desk only handles initial study submissions. The research team is responsible for the submission of modifications and amendments to the hospital-faculty ethics committee as well as for the follow-up of clinical research: annual reports for interventional studies, deviations, violations, unexpected events, SAE with death, notifications of the end of the study. The documents related to the follow-up of the research are available on the website of the hospital-faculty ethics committee via this link (https://www.saintluc.be/en/ethics-committee-Clinical-investigations)
TRIAL MASTER FILE
If the Cliniques universitaires Saint-Luc is the sponsor of the study, a Trial Master File template is sent to the principal investigator, so that they have a set of study documents in order at the regulatory level.
ENTERING THE STUDY IN CLINICALTRIALS.GOV
When the the Cliniques universitaires Saint-Luc promote an intervention study,the central academic desk also offers help to record the study on the clinicaltrials.gov website. . Indeed, any prospective intervention study must be available to the public. A record in a public database is also required for any subsequent publication.
Update: February 2026
