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Clinical trial agreements management

Dear sponsor/CRO of a commercial research,

The commercial central desk is from now on the single access path to the Ethics Committee (EC) for initial submissions of the commercial studies.

The approval of the principal investigator for performing the experiment must be obtained by the sponsor prior to any contract negotiation.

Guidelines for the contract management

In case of « CTR Pilot » studies, please follow also the procedure hereunder by adding the study protocol and the informed consent document.

New clinical trial agreements and related documents described below must be submitted to the commercial central desk ( guichetcommercial-saintluc@uclouvain.be ).

1: PLEASE READ THE DOCUMENT CTA requirements for biomedical research performed at Cliniques universitaires Saint-Luc (for the sponsors)

2: FILL IN THE ATTACHED CONTRACT SET-UP QUESTIONNAIRE AND THE QUESTIONNAIRE N°1

3: SEND THE FOLLOWING DOCUMENTS BY EMAIL TO guichetcommercial-saintluc@uclouvain.be

  • The contract set-up questionnaire
  • The complete study protocol with a flow chart
  • The patient information sheet and the informed consent form
  • The selected draft of the agreement
  • A budget proposal

3: The submission will then be controlled for completeness by the contract management team.

Please take into account that the contract review time can be accelerated when an already validated template is proposed :

  • Either the attached commercial template validated by the Belgian academic hospitals (CTA COMMERCIAL CHAB 10-2018.docx)
  • Either a master agreement already negotiated between your company and the Cliniques universitaires Saint-Luc
  • Either a recent (<1 year) contract validated by the Cliniques universitaires Saint-Luc

In other cases, please adapt the agreement according to the established criteria described in the CTA requirements document cited above (see point 1).

Documents

  1. CTA COMMERCIAL CHAB 10-2018.docx
  2. TransCelerate Site Profile Form
  3. 1-044-AAHRPP-DSQ-013: CTA requirements for biomedical research performed at Cliniques universitaires Saint-Luc (for the sponsors)
  4. 045-AAHRPP-FORM-037 : Questionnaire to the commercial sponsor of a biomedical research : Budget evaluation



Update: octobre 2018