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

SUBMISSION DOCUMENTS REQUIRED ACCORDING TO THE TYPE OF STUDY

To help you determine the type of study for your project, consult the clinical study flowchart

TYPE OF STUDY

DOCUMENTS TO BE PROVIDED

INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) - CTR UCL SPONSOR

Before preparing the submission file, contact the UCLouvain academic central desk and provide the following documents (available on request): Clinical trial protocol, Statistical analysis plan, Study data management plan, Study monitoring plan, Risk management plan, DSMC Charter (if necessary). 
Also include project funding plan, Number of patients expected, Initial questionnaire GDPR.
The desk officer will assist you in preparing the submission package.

INTERVENTIONAL DEVICE STUDY (DEVICE) - MDR UCL SPONSOR

- Flowchart to be consulted to determine the type of device and submission

Before preparing the submission file, contact the UCLouvain academic central desk and provide the following documents (available on request): Protocol, Statistical analysis plan, Study data management plan, Study monitoring plan, Risk management plan, DSMC Charter (if necessary). 
Also include project funding plan, Number of patients expected, Initial questionnaire GDPR.
The desk officer will assist you in preparing the submission package.

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 CUSL 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 CUSL sponsor, CRF, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants

RETROSPECTIVE STUDY

Simplified submission form, research description letter, initial questionnaire GDPR, informed consent or exemption request, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting CUSL sponsor, CRF

RESIDUAL HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA

Simplified submission form, research description letter, initial questionnaire GDPR, draft contract and budget, dated and signed CV (<3 years) of the principal investigator and co-investigators, financial reporting CUSL sponsor

TEMPLATES FOR SUBMISSION DOCUMENTS

Related documents

Document 1

Download

Acknowledgement of receipt

Simplified submission form

Download

Simplified submission form for master/bachelor thesis

Download

Declaration of conflict of interest form

Download

Summary of anti-corruption rules

No conflicts of interest for the research team

Download

External sponsor insurance form (if no insurance certificate)

Download

GDPR - Initial Questionnaire

Download

Financial reporting academic sponsor

Download

Protocol

Clinical trial protocol

Download

Medical device protocol type

Download

Clinical interventional study protocol

Download

Non-interventional or retrospective clinical study protocol

Download

Informed consent

Information checklist for informed consent

Download

Informed consent for clinical research without medicinal product or device

Download

Informed consent for clinical trial with a medecinal product or device

Download

Informed consent for observational study

Download

Informed consent adults temporarily incapable

Download

Informed consent emergency

Download

Request for exemption to consent

Download

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.

 

Update: July 2022