CLINICAL TRIALS without MEDICINAL PRODUCT (NL: “Experiment)
ICF Adults
ICF Short Version Prospective Observational Study
ICF Short Version Retrospective Study
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 1.0 Effective date 2022-07-18 – ENG
Serious Adverse Event Form
- FRM SAE for trials with medicinal products – Version 5.0 Effective date 2022-07-18 – ENG
Final Study Report
- TMP Final study report – Version 2.0 Effective date 2022-07-18 – ENG
MEDICAL DEVICE TRIALS
Clinical Investigation Plan
- TMP Clinical Investigation Plan for medical device trials – Version 5.0 Effective date 2022-07-18 – ENG
Serious Adverse Event Form
- FRM SAE for medical device trials – Version 5.0 Effective date 2022-07-18 – ENG