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Clinical Trial Center

Clinical research: initial submission procedure

The commercial central desk is now in charge of the initial submission of commercial studies and the single access path to the Ethics Committee :

Contact person: Ms. Sandra Cueto-Lopez - guichetcommercial-saintluc@uclouvain.be - Tel: + 32 2 764 13 31.

The investigator remains the initial contact person for the site selection.

A soon as the site is selected, the commercial central desk coordinator:

  • contacts the sponsor/CRO about the submission documents.
  • transfers all the documents concerning the contract management to the contracts, finances and reporting (CoFi) team.
  • takes charge of the signatures and the achievement of the submission package.
  • gives the green light for the submission to the Ethics Committee once the package is complete and responding to the regulatory requirements.
  • submits the package and receives it on behalf of the EC. Studies are directly planned for the next Committee's meeting.

To the sponsors of clinical research : procedures and templates for the file submission to the Ethics Committee.

Submission procedures

Submission procedure of a clinical research project to CEHF Français English

Associated documents

Commercial studies Non commercial studies (academic)
Check list submission Français English Check list submission Français English
Document 1 Français English Document 1 Français English
Invoice form Français English /
Acknowledgement of receipt Acknowledgement of receipt
Contact information sheet Français English /
Simplified submission form Français English Simplified submission form Français English
Form to declare potential conflict of interest Français English Form to declare potential conflict of interest Français English
Sponsor's declaration for the no-fault insurance Français / Sponsor's declaration for the no-fault insurance Français /
Data privacy protection in clinical research Français English Data privacy protection in clinical research Français English
/ Data privacy protection in clinical research for UCLouvain Français English

Amendment submission

Amendment submission to Ethics Committee Français English

Associated documents

Commercial studies Non commercial studies (academic)
Check list submission Français English Check list submission Français English

Information and consent forms (ICF)

Introduction To Information And Informed Consent Form For Adults Temporarily Incapable Of Making An Autonomous Decision Français Nederlands English
Introduction To Information And Informed Consent Form For Inclusion In A Clinical Study In An Emergency Français Nederlands English
Model Of Information And Informed Consent Form For Non-Interventional Study/Trial (Observational) On Adults. Français Nederlands English
Model Of Information And Informed Consent Form For Interventional Trial On Adults Français Nederlands English


Documents related to end-of-study dissertations

There are three types of dissertations:

  1. Interventional studies (with or without medicinal product) on Saint-Luc patients except out of routine questionaires or surveys
    • Must be submitted via the 'Claire' database by a CUSL employee who will be responsible for the study.
    • Submitted with the full Document 1
    • Request insurance/ CV (dated and signed)/ informed consent form/ potential budget/ protocol,…
    • Subject to the same rules as other prospective experiments with regards to the patients being recorded in the database Claire, submission annual report,…
  2. Interventional studies (with or without medicine) on patients outside Saint-Luc
    • Same as 1. - but the study record will be done by the Ethics Committee
  3. Non-interventional or retrospective studies or interventional studies constiting ONLY of out of routine questionaires or surveys
    • Will be recorded by the Ethics Committee
    • Must be submitted via the simplified submission form
    • For retrospective studies, provide in addition:
      • student's CV / mentor's CV (dated and signed)
      • Summary of the study
    • For non-interventional studies and interventional studies constiting ONLY of questionaires or surveys out of routine, provide in addition:
      • Insurance certificate
      • Informed Consent Form
      • Student's CV / mentor's CV (dated and signed)
      • Protocol
      • Possibly, the patient's questionnaire
    • No annual report, no recording in the 'Claire' database.



Update: March 2019