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 UCLouvain academic central desk can be reached at: guichetacademiqueuclouvain-saintluc@uclouvain.be and 02 764 79 80


SUBMISSION DOCUMENTS REQUIRED ACCORDING TO THE TYPE OF STUDY

TYPE OF STUDY

DOCUMENTS TO BE PROVIDED

INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL)

Protocol, summary in French (1 page), document 1, questionnaire 1, informed consent, insurance application form, draft contract and budget, conflict of interest declaration form for the principal investigator and co-investigators, CTA form, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investigators.

→ Registered drug

+ Scientific notice

→ Unregistered drug

+ Investigator brochure

INTERVENTIONAL DEVICE STUDY

(DEVICE)

Protocol, summary in French (1 page), document 1, questionnaire 1, informed consent, insurance application form, draft contract and budget, conflict of interest declaration form for the principal investigator and co-investigators, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investigators.

→ If CE mark and in the indication

+ CE label and device manual

→ If CE mark but not in the indication

+ CE label, investigator's brochure, device manual and FAMHP file

→ If no CE mark

+ Investigator brochure and FAMHP file

OTHER INTERVENTIONAL STUDY

Protocol, French summary (1 page), document 1, questionnaire 1, informed consent, insurance application form, draft contract and budget, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investigators.

NON-INTERVENTIONAL STUDY

Protocol, French summary (1 page), document 1, questionnaire 1, informed consent, insurance application form, draft contract and budget, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investigators.

RETROSPECTIVE STUDY

Simplified submission form, research description letter, questionnaire 1, informed consent or exemption request, draft contract and budget, dated and signed CV (<2 years) of the principal investigator and co-investigators.

RESIDUAL HUMAN BODY MATERIAL WITHOUT DATA OTHER THAN MATERIAL IDENTIFICATION DATA

Simplified submission form, research description letter, questionnaire 1, draft contract and budget, dated and signed CV (<2 years) of the principal investigator and co-investigators.


TEMPLATES FOR SUBMISSION DOCUMENTS

Submission procedures

Procedure for the submission of a new clinical research project.

Download

Academic studies (non-commercial)

Check list of documents to be submitted

Download

Document 1

Download

Acknowledgement of receipt

Simplified submission form

Download

Declaration of conflict of interest form

Download

Clinical Research Privacy Protection: Questionnaire 1 for UCLouvain

Download

The submission file is sent to the ethics committee electronically, so a paper version of the submission file is no longer required.


TEMPLATES FOR ACADEMIC CONTRACTS

- Template of academic contract validated by academic hospitals .

- CUSL/UCL Clinical Study Contract

- Material Transfer Agreement

- Material Transfer Agreement CUSL/UCL

- 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:

  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.

  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. A submission to the competent authorities is also made on the same day for drug or medical device studies.

The UCLouvain central academic desk only handles initial study submissions. Changes and amendments are managed by the research team and forwarded directly to the Ethics Committee. It also takes charge of clinical research continuing review: annual reports for interventional studies, DSUR for investigational medicinal product studies as well as SUSARs, deviations, violations, unexpected events, SAE with death, end of study notifications. Documents relating to the clinical research continuing review are available on the website of the hospital-faculty ethics committee via this link: https://www.saintluc.be/en/research/ethics-committee-continuing-review.php


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 to encode 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: October 2019