Clinical Trials without medicinal product (nl: “Experiment)
ICF Adults
ICF Short Version Prospective Observational Study
ICF / Information Letter Retrospective Study
- For retrospective studies in which data is transferred to a country outside the EEA that is not on the white list, explicit consent of the participant is needed (in-house rule).
In that case the template ICF Short Version Retrospectieve Study Adults should be used:
- Ghent University Hospital aims to inform its patients as much as possible regarding the use of their data via the patient portal or the patient portal and an information form/ICF.
The template Information Letter Retrospective Study Adults can be used:
ICF Parents-Guardian of Participating Children
ICF Children aged 12-17 years
Clinical trials with medicinal product (nl: “Proef’)
ICF Adults
ICF Pregnancy follow-up during and/or after the trial
Pediatric clinical trials with medicinal product (nl: “Proef’)
ICF Parents-Guardian of Participating Children
ICF Children aged 8-11 years
ICF Children aged 12-17 years
ICF Children aged 18 years during the study
Other templates clinical trials with medicinal product (nl: “Proef’)
Study Protocol
- TMP Clinical Study Protocol CTR – Version 1 Publication date 2023-11-02 – ENG
Serious Adverse Event Form
- FRM SAE for trials with medicinal products – Version 2 Publication date 2024-07-08 – ENG
Final Study Report
- TMP Final study report – Version 1 Publication date 2023-11-02 – ENG
Medical device trials
Clinical Investigation Plan
- TMP Clinical Investigation Plan for medical device trials – Version 2 Publication date 2024-06-14 – ENG
Serious Adverse Event Form
- FRM SAE for medical device trials – Version 2 Publication date 2024-07-15 – ENG