Study Submission Confirmation and Next Steps

Thank you for submitting your study to our Clinical Trial Center. We hereby confirm the receipt of your dossier.

Before we start to review the documents internally and start the contract negotiations, we would like to request the following information so the start-up can go smoothly:

• Can you please make sure all fields are completed in our online submission form regarding the supporting department so they have all necessary information available to review the contract?
• Can you please provide all manuals (laboratory, pharmacy, radiology, pathology, etc) so all necessary information is available for the contract negotiations?
• Please share the submitted ICF as well so this information can be cross-checked with the protocol?
• Can you please provide as much practical information as possible regarding the conduct of the study:
  • PI department:
    • If urine pregnancy tests are necessary for the study, will these be provided by the sponsor or not?
    • Is there specific equipment needed for this study, please provide this as much as possible by the sponsor, or communicate this clearly well in advance?
  • Lab department:
    • Will samples be analysed in the central lab or local lab? If it is a mix, please specify which analyses need to be performed locally so our lab can check if this is feasible on site.
    • Will lab kits be provided or is local material needed?
  • Pathology department:
    • Is local processing necessary or it there only shipment of tissue needed? For your information, if tumour blocks need to be shipped to the sponsor, these need to return to our hospital for further storage.
  • Radiology department:
    • Are specific settings requested for the radiological images of the study?
  • Pharmacy department:
    • Will medication be provided by the sponsor? And is compounding needed?
  • Cardiology department:
    • Will the sponsor provide an ECG device or not?
  • Can you please share your timelines about when the study will be submitted to the EU CTR platform CTIS or to the central EC so we can take this into account in prioritizing the dossiers?

More information about the contract negotiations, you can find here. 

Once we received all necessary information, the dossier will be reviewed internally and further processed according to the applicable procedure within the CTC.

Please do not hesitate to contact us if you have any further questions or additional information to share.

Clinical Trial Center Team
clinical.trials@stlucas.be
050 36 57 11