Flow opstart klinische studie

1. Conceptualization

Feel free to contact CTC/EC early on when planning a project; for complex projects a joint brainstorm may clear the way for smooth sailing later on!

2.1. Study registration

All clinical trials require to be registered via: https://www.uzleuven.be/en/register-clinical-study-clinical.

2.2 PI acceptance

Because anyone can register a study, the PI will receive an automated email to accept or decline the study. Due to IT restrictions, CTC will accept trial registrations on behalf of KUL investigators.

2.3 Automatically assigned S-number

For ease of communication, the UZ Leuven internal S-number is immediately assigned. Supporting departments are automatically notified of the upcoming study and wait to be contacted by the study team/sponsor.

2.4 CTC acceptance

Review of electronic registration form: clarifications may be requested. If the project intent & sponsorship are clear and required key information is provided; than the project dossier is declared admissible and internal project reviews by the stakeholders are initiated.

2.5 CTC 'green lights'

• Financial green light: Agreement on financial flowchart & assurance that financial means are sufficient to cover trial related hospital costs.
• Legal green light: To assure consensus for legal collaboration grounds and absence of important legal issues.
• Safety green light: To assure the safety section in the protocol is clear & complete.

2.6 CTC validation

All major concerns (if any) have been addressed; the study team/sponsor can submit the dossier for parallel EC & FAMHP review (if applicable). If required, CTC issues a statement of suitability of the UZL trial site facility.

3.1 EC/CA submision

The study is submitted by sponsor/study team to EC/CA who assess investigator qualifications, trial design and adequacy of trial documents to assure the rights & wellbeing of trial participants and compliance with applicable regulations, GCP, GDPR & internal policies.

3.2 EC/CA approval

The study receives EC (and if applicable CA) approval

4. Study start-up

The study may start when: EC & FAMHP approval (if applicable) is obtained, overall study cost estimate is accepted by the PI & financing secured, all legal documents are final & duly signed, operational manuals, project plans & trial supplies are available,…