Academic study UCLouvain
The UCLouvain central academic desk is the only access point to the ethics committee (CEHF) for academic studies (UCLouvain promoter). It is also the contact point for promoters, 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 02/764 79 80
Organisation Management Service (OMS) registration number : Catholic University de Louvain - ORG-100021633 - LOC-100030343
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, Financial reporting academic sponsor, Drug supply arrangements, Number of planned patients (breakdown by sites), Initial GDPR questionnaire. |
|
INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR UCL SPONSOR |
- Flowchart to be consulted to determine the type of device and submission Contact the academic central desk UCLouvain and provide the following documents: Clinical trial protocol, Financial reporting academic sponsor, Device supply arrangements, Number of planned patients (breakdown by sites), Initial GDPR questionnaire. |
|
OTHER INTERVENTIONAL STUDY |
Protocol, French summary (1 page), document 1, 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, financial reporting academic sponsor, CRF, 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 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, financial reporting academic sponsor, CRF, 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, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting academic sponsor, CRF In the context of a retrospective study, patients must be informed of the use of their medical data. |
|
RESIDUAL HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA |
Simplified submission form, research description letter, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting academic sponsor |
TEMPLATES FOR SUBMISSION DOCUMENTS
Related documents |
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| Financial reporting academic sponsor | English | French | |
Protocol |
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Informed consent |
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| 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 |
| GDPR information for registry | English | French | |
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
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 central academic desk UCLouvain:
- Reads the documents and sends an email acknowledging receipt and notifying the missing documents.
- Creates the study in the Claire software (studies taking place at Cliniques universitaires Saint-Luc), so that the investigator of the hospital can monitor the progress of the file via tracking indicators (date of first contact, date of receipt of documents, date of regulatory pre-analysis, date of regulatory approval, date of financial approval, date of insurance request, date of request for DPO or legal opinion, date of receipt of all documents finalized for submission to CEHF).
- Pre-analyses the documents.
In the case of a study involving a drug or medical device, sends the documents for the submission file to the UCL sponsor. - Sends the draft contracts to the research administration (ADRE) of UCLouvain.
- Submits any internal agreements of the hospital to the contracts and finance unit.
- Fills in the insurance application with the insurance department of UCLouvain.
- Submits the file to the ethics committee once the file is complete and in order from a regulatory/financial point of view. Makes the submission to the competent authorities for studies involving a drug or medical device.
In the case of a study involving a drug or medical device for which the sponsor is UCL, the UCLouvain academic central office 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 office 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: https://moodle.uclouvain.be/user/index.php?id=6089
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: April 2024
