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.

The academic desk officer will help you prepare the submission file after assessing the feasibility of your project.

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.

The academic desk officer will help you to determine the type of submission required and to prepare the submission file after assessing the feasibility of your project.

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. 
CuSL site: the patient is informed via the website and the hospitalization notebook. 
Other sites (UCL sponsor): Ensure that information is available to the patient, or provide a specific document.

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

Document 1

Acknowledgement of receipt

Simplified submission form

Simplified submission form for master/bachelor thesis

Declaration of conflict of interest form

No conflicts of interest for the research team

Summary of anti-corruption rules

UCLouvain sponsor insurance application form

GDPR - Initial Questionnaire

Financial reporting academic sponsor English French  

Protocol

Clinical trial protocol type

Medical device protocol type

Clinical interventional study protocol type

Non-interventional clinical study protocol English French  
Retrospective clinical study protocol English French  

Informed consent

Information checklist for 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
GDPR information for registry English French  

TEMPLATES FOR ACADEMIC CONTRACTS AND ASSOCIATED DOCUMENTS

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:

  1. Reads the documents and sends an email acknowledging receipt and notifying the missing documents.

  2. 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).

  3. 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.

  4. Sends the draft contracts to the research administration (ADRE) of UCLouvain.

  5. Submits any internal agreements of the hospital to the contracts and finance unit.

  6. Fills in the insurance application with the insurance department of UCLouvain.
     
  7. 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: February 2024