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 and the price list of the different departments involved in clinical research 
  2. Complete the « Contract set-up questionnaire » and questionnaire 1.
  3. 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
  4. 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

Contract template for commercial studies validated by the academic hospitals and Pharma.be.

Transcelerate Site Profile Form.

Budget evaluation questionnaire

Electronic System Validation

 

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)

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 (<3 years) and GCP certificate (< 3 years) of the principal investigator and co-investigators.

→ Registered drug

+ Scientific notice

→ Unregistered drug

+ Investigator brochure

INVESTIGATIONAL DEVICE STUDY (DEVICE)

- Flowchart to be consulted to determine the type of device and submission
- Checklist of documents to be submitted for device study

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 (<3 years) and GCP certificate (< 3 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 (<3 years) and GCP certificate (< 3 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 (<3 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, declaration of conflict of interest form for the principal investigator and co-investigators, acknowledgement of receipt, information sheet, invoicing form, dated and signed CV (<3 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

Flowchart to determine the type of device and submission

Download

Related documents

Checklist of documents to be submitted

Download

Checklist of documents to be submitted for device study

Download

Document 1

Download

Invoicing form

Download

Acknowledgement of receipt

Contact information sheet

Download

Simplified submission form

Download

Declaration of conflict of interest form

Download

External sponsor insurance form (if no insurance certificate)

Download

Clinical Research Privacy Protection: Questionnaire 1

Download

Protocol

Clinical research protocol

Download

Medical Device protocol type

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

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. 

A study submitted to the Ethics Committee by the central commercial desk is considered as a complete and valid submission. As such, the study is placed on the agenda for the next meeting. Submissions are closed by the Ethics Committee on Wednesday for the meeting held 12 days later (every Monday).

In practice, the external partner is advised to send the documents to be signed by the investigators to the CTC commercial desk as soon as possible.

As for the complete submission package, it should be sent at least 2 days before the desired submission date.

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

 

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.

Documents required as soon as they are available:

- CEO statement

- Conflicts of interests declarations

- No-fault insurance validity date

- Number of patients to be recruited at the CUSL

- GDPR Questionnaire 1

- Submission package containing the final documents approved by the Ethics Committee

COMPASSIONATE USE

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

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


 

Update : November 2021