ACADEMIC STUDY

The central academic desk is the only access point to the ethics committee (CEHF) for academic studies (CUSL or external promoter). It is also the contact point for promoters, investigators and research coordinators for the initial submission of academic studies.


CONTACT DETAILS

The central academic desk can be reached at: guichetacademique-saintluc@uclouvain.be and 02/764.17.44 .


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, declaration of insurance form (+ certificate of insurance if external promoter), draft contract and budget, declaration of conflicts of interest 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-investors.

→ Registered drug

+ Scientific notice

→ Unregistered drug

+ Investigator brochure

INTERVENTIONAL DEVICE STUDY

(DEVICE)

Protocol, summary in French (1 page), document 1, questionnaire 1, informed consent, declaration of insurance form (+ certificate of insurance if external promoter), draft contract and budget, declaration of conflicts of interest form of the principal investigator and co-investigators, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investors.

→ 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, summary in French (1 page), document 1, questionnaire 1, informed consent, declaration of insurance form (+ certificate of insurance if external promoter), draft contract and budget, acknowledgement of receipt, dated and signed CV (<2 years) of the principal investigator and co-investigators.

NON-INTERVENTIONAL STUDY

Protocol, summary in French (1 page), document 1, questionnaire 1, informed consent, declaration of insurance form (+ certificate of insurance if external promoter), 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

External Promoter's Statement of Assurance Form

French

Clinical Research Privacy Protection: Questionnaire 1

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 informed consent document and a budget evaluation, they send an email to the central academic desk (guichetacademique-saintluc@uclouvain.be) with the documents listed as attachments.

The central academic desk:

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

  2. Creates the study in the Claire software so that the Cliniques universitaires Saint-Luc investigator 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 drafts contract to the contracts and finance unit as part of a multi-centre study.

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

  6. Fills in the insurance application if the Cliniques universitaires Saint-Luc is the sponsor of the study.

  7. Requests regulatory approval from the quality and regulatory coordinator.

  8. Requests financial approval from the head of the contracts and finance unit for monocentric studies.

  9. Submits the file to the ethics committee once it is complete and in order from a regulatory/financial point of view. Studies involving a medicinal product or medical device are also submitted to the competent authorities on the same day.

The 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 the Cliniques universitaires Saint-Luc is the sponsor of the study, a Trial Master File template is sent 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

When the the Cliniques universitaires Saint-Luc promote an intervention study, the central academic desk also offers to encode the study on the clinicaltrials.gov website. . Indeed, any prospective intervention study must be available to the public. A record in a public database is also required for any subsequent publication.