COMMERCIAL STUDY


The central commercial desk is the only access point to the ethics committee (CEHF) for commercial studies; it is also the contact point for commercial sponsors.


CONTACT AND CONTACT DETAILS

The central commercial desk can be reached at: guichetcommercial-saintluc@uclouvain.be and 02/764.13.31 .


PROCEDURE FOR MANAGING CLINICAL RESEARCH CONTRACTS

Clinical research contracts and the documents described below must be sent to the commercial desk, which then transfers them to the Contracts and Finance Unit (CoFi).

Procedure for submitting clinical research contracts (for commercial study sponsors):

  1. Read the Cliniques universitaires Saint-Luc requirements document
  1. Complete the Contract set-up questionnaire and Questionnaire 1.
  1. Send the following documents to the central commercial desk
  • Contract set-up questionnaire
  • Questionnaire 1
  • Study protocol and flowchart
  • Information and informed consent document
  • Draft research contract
  • Budget evaluation
  1. The central commercial desk then forwards all the documents to the contracts and finance unit, which will be responsible for revising the research contract.

Contract review time can be accelerated when a validated template is proposed.

  • Either the commercial contract template validated by the Belgian academic hospitals and Pharma.be
  • Either a master agreement already negotiated between the hospital and the sponsor
  • Either a recent contract (< 1 year) already validated by the hospital

In other cases, please take into account the requirements mentioned in the document referred to in point 1.


COMMERCIAL CONTRACT TEMPLATE AND ASSOCIATED DOCUMENTS

- Template of commercial contract validated by the academic hospitals and Pharma.be .

- TransCelerate Site Profile Form .

- Budget evaluation questionnaire


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, draft contract, declaration of conflict of interest form of the principal investigator and co-investigators, CTA form, acknowledgement of receipt, information sheet, invoicing form, dated and signed CV (<2 years) of the principal investigator and co-investigators.

→ Registered drug

+ Scientific notice

→ Unregistered drug

+ Investigator brochure

INVESTIGATIONAL DEVICE STUDY

(DEVICE)

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

→ If CE mark and in the indication

+ CE mark and device manual

→ If CE mark but not in the indication

+ CE mark, 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, draft contract, declaration of conflict of interest form for the principal investigator and co-investigators, acknowledgement of receipt, information sheet, invoicing form, 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, draft contract, declaration of conflict of interest form for the principal investigator and co-investigators, acknowledgement of receipt, information sheet, invoicing form, 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, conflict of interest declaration form for principal investigator and co-investigators, dated and signed CV (<2 years) of 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, declaration of conflict of interest form for the principal investigator and co-investigators, acknowledgement of receipt, information sheet, invoicing form, 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

Related documents

Checklist of documents to be submitted

Download

Document 1

Download

Invoicing form

Download

Acknowledgement of receipt

Information sheet

Download

Simplified submission form

Download

Declaration of conflict of interest form

Download

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.


INITIAL SUBMISSION PROCEDURE

Once the site has been selected and the study accepted by the principal investigator, the required documents are sent to the central commercial desk (guichetcommercial-saintluc@uclouvain.be).

The central commercial desk:

1. Receives the documents

2. Transfers the contract to the contracts and finance unit

3. Checks that the submission package is complete

4. Collects the necessary signatures

When the submission package is complete, the central commercial desk submits the study to the ethics committee for review and approval and informs the sponsor and investigator. The contract is reviewed in parallel with the submission by the contracts and finance unit of the Clinical Trial Center.

The central commercial 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


CTR PILOT STUDIES

« CTR Pilot » commercial studies conducted at the Cliniques universitaires Saint-Luc and reviewed by an independent ethics committee must be notified to the central commercial desk.

In the case of CTR pilot studies, please follow the procedure for managing clinical research contracts by adding the study protocol and informed consent.


COMPASSIONATE USE

When donating medicines for compassionate use, please send any agreement to the central commercial desk.

A « Data Processing Agreement » is required if medical data from the patient receiving the medication is sent to the pharmaceutical company providing the medication.