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 Initial questionnaire GDPR.
  3. Send the following documents to the central commercial desk
    • Contract set-up questionnaire
    • Initial questionnaire GDPR
    • 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

- Computer system compliance with FDA21CFR Part 11

 

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, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, 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, scientific notice if registered drug, investigator brochure if unregistered drug, any other document for the patient (questionnaire, diary, scale, ...) in the language of the participants.

INVESTIGATIONAL MEDICINAL PRODUCT STUDY (CLINICAL TRIAL) CTR

Contact the commercial central desk for commercial clinical trials CTR conducted at Cliniques universitaires Saint-Luc.
Please follow the procedure for managing clinical research contracts described above.
Additional documents required as soon as they are available:
CEO statement, financial diclosure form for PI, declaration of PI for research team, no-fault insurance certificate, number of patients to be recruited at CUSL, initial questionnaire GDPR.

INVESTIGATIONAL DEVICE STUDY (DEVICE) MDR

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

Contact the commercial central desk for commercial clinical investigations conducted at Cliniques universitaires Saint-Luc.
Please follow the procedure for managing clinical research contracts described above.
Additional documents required as soon as they are available:
Suitability of site, financial diclosure form for PI, declaration of PI for research team, no-fault insurance certificate, number of patients to be recruited at CUSL, initial questionnaire GDPR.
Documents required if regulathory pathway is Validation by local EC or Separate opinion of FAMHP and local EC :
Provide the documents according to the design of the study (interventional, non-interventional, retrospective or MCHr) and add : 
If CE label and in the indication: CE label and device manual
If no CE label: Investigator brochure and FAMHP file

OTHER INTERVENTIONAL STUDY

Protocol, French summary (1 page), document 1, initial questionnaire GDPR, informed consent, insurance, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, 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, 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, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, 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, 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, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, 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, initial questionnaire GDPR, draft contract and budget, declaration of conflict of interest form for the principal investigator, declaration of PI for research team, dated and signed CV (<3 years) of the principal investigator and co-investigators.

TEMPLATES FOR SUBMISSION DOCUMENTS

Related documents

Document 1

Download

Invoicing form

Download

Acknowledgement of receipt

Contact information sheet

Download

Simplified submission form

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

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 commercial central office handles only initial study submissions. Modifications and amendments are managed by the research team and transmitted directly to the ethics committee. The research team is also responsible for the follow-up of clinical research for studies other than CTR/MDR: annual reports for interventional studies, deviations, violations, unexpected events, SAEs with deaths, and end of study notifications. Documents related to the clinical research continuing review are available on the ethics committee website via this link (https://www.saintluc.be/en/ethics-committee-Clinical-investigations)

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 : July 2022