Academic study UCLouvain
The UCLouvain central academic desk is the only access point to the ethics committee (CEHF) for academic studies (UCLouvain sponsor). It is also the contact point for sponsors, investigators and students for the initial submission of academic studies taking place at UCLouvain.
CONTACT DETAILS
The central academic desk can be reached at : guichetacademiqueuclouvain@saintluc.uclouvain.be and 02/436 10 37
Organisation Management Service (OMS) registration number : Catholic University de Louvain - ORG-100021633 - LOC-100030343
INITIAL SUBMISSION PROCEDURE
Once the sponsor or principal investigator has at least a research protocol, an information and consent document and a budget evaluation, they send an email to the UCLouvain central academic desk (guichetacademiqueuclouvain@saintluc.uclouvain.be) with the documents mentioned in attachments.
The UCLouvain central academic desk:
- sends an email acknowledging receipt and reads the documents received
- creates the study in the Claire software (studies taking place at the Cliniques universitaires Saint-Luc) so that the Cliniques investigator can track the progress of the file via tracking indicators.
- performs a preliminary analysis of the documents
- sends draft contracts to the UCLouvain research administration (ADRE)
- submits any internal Cliniques agreements to the contracts and finance unit
- submits the insurance application to the UCLouvain insurance department
- submits the file to the hospital-faculty ethics committee when it is complete and in order from a regulatory/financial point of view.
If the study involves a drug or medical device, the UCLouvain academic desk:
- conducts, together with the investigator-sponsor, a more detailed feasibility assessment, including an evaluation of the risks of the project
- sends the UCL sponsor the necessary documents and helps them to compile the submission file
- 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 UCL SPONSOR | Contact the academic central desk UCLouvain and provide the following documents: Clinical trial protocol, Drug supply arrangements, Number of planned patients (breakdown by sites), UCLouvain Initial GDPR questionnaire, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator. If CUSL patients: To be obtained from the CUSL PI: conflict of interest declaration form, conflict declaration for the research team, dated and signed CV (<3 years old) and GCP certificate (<3 years old), academic sponsor financial declaration (completed by the PI), PI and CUSL Head of Service signature page, initial CUSL GDPR questionnaire. |
| INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR/IVDR UCL SPONSOR | - Flowchart to be consulted to determine the type of device and submission FAMHP submission : Contact the academic central desk UCLouvain and provide the following documents: Clinical trial protocol, Device supply arrangements, Number of planned patients (breakdown by sites), UCLouvain Initial GDPR questionnaire, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator. CEHF submission: Provide the documents required for an interventional study and add: If CUSL patients: Obtain from the CUSL PI: conflict of interest declaration form, conflict declaration for the research team, dated and signed CV (<3 years old) and GCP certificate (<3 years old), academic sponsor financial declaration (completed by the PI), PI and CUSL Head of Service signature page, initial CUSL GDPR questionnaire.
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| OTHER INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, UCLouvain initial questionnaire GDPR, informed consent, insurance application form, draft contract and budget, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, CRF, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants If CUSL patients: Obtain from the CUSL PI: dated and signed CV (<3 years old) and GCP certificate (<3 years old) of the principal investigator and co-investigators, academic sponsor financial declaration (completed by the PI), initial CUSL GDPR questionnaire. |
| NON-INTERVENTIONAL STUDY | Protocol, French summary (1 page), document 1, UCLouvain initial questionnaire GDPR, informed consent, insurance application form, draft contract and budget, acknowledgement of receipt, dated and signed CV (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators, CRF, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants If CUSL patients: Obtain from the CUSL PI: dated and signed CV (<3 years old) and GCP certificate (<3 years old) of the principal investigator and co-investigators, academic sponsor financial declaration (completed by the PI), initial CUSL GDPR questionnaire. |
| RETROSPECTIVE STUDY | Simplified submission form, protocol, UCLouvain initial questionnaire GDPR, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, CRF If CUSL patients: Obtain from the CUSL PI: dated and signed CV (<3 years old), academic sponsor financial declaration (completed by the PI), initial CUSL GDPR questionnaire. Participants consent : in the context of a retrospective study, participant consent is not necessary, participants must only be informed of the use of their medical data.
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| HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA (RESIDUAL or SECONDARY USE) | Simplified submission form, research description letter, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators If CUSL patients: Obtain from the CUSL PI: dated and signed CV (<3 years old), academic sponsor financial declaration (completed by the PI) |
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 CUSL/UCL
- Data Transfer Agreement
- CUSL/UCL service provision contract
AMENDMENT AND STUDY FOLLOW-UP
In the case of a study involving a drug or medical device for which the sponsor is UCL, the UCLouvain academic central desk is responsible for submitting modifications and amendments to the competent authorities, as well as for the follow-up of clinical research: annual report (ASR), SUSAR, deviations, violations, unexpected events, SAE with death, and end-of-study notifications.
For other types of studies, the UCLouvain academic central desk only handles initial 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 the clinical research: annual reports for interventional studies, deviations, violations, unexpected events, SAE with death, end of study notifications. 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 UCLouvain is the sponsor of the study, a Trial Master File template will be proposed 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
If UCLouvain is the promoter of an interventional prospective study, the UCLouvain central academic desk also offers help to record the study in the clinicaltrials.gov website. Indeed, any prospective intervention study must be accessible to the public. A record in a public database is also required for any subsequent publication.
TRAINING IN GOOD CLINICAL PRACTICE - GCP
The Clinical Trial Centers (CTC) of the 7 Belgian university hospitals have developed together a GCP training validated by Transcelerate on behalf of the CHAB (Conférence des Hôpitaux Académiques de Belgique). Here is the link accessible to anyone with a UCLouvain email address: GCP Training validated by Transcelerate | MoodleUCLouvain
The registration key is the following: #Formation!GCP_2023#
When you have completed the training, you will be asked a few questions. If you get >80%, your GCP certificate will be generated automatically.
Update: February 2026
