Due to the implementation of a new quality system at HIRUZ the version number and publication date, previously called effective date, have been changed for almost all templates.
However the content of the templates has not been adapted.
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 1 Publication date 2023-11-02 – 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 1 Publication date 2023-11-02 – ENG
Serious Adverse Event Form
- FRM SAE for medical device trials – Version 1 Publication date 2023-11-02 – ENG