Clinical Trials without medicinal product (nl: “Experiment)
ICF Adults
ICF Short Version Prospective Observational Study
- TMP ICF Experiment Short Version Prospective Observational Study – Version 4.0 Effective date 2023-01-09 – NL | FR | ENG
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:
- TMP ICF Short Version Retrospective Study Adults – Version 4.0 Effective date 2023-01-09 – NL | FR | ENG
- In all other cases, informing the participants about the retrospective study is sufficient and the template Information Letter Retrospective Study Adults should used:
- TMP Information Letter Retrospective Study Adults – Version 1.0 Effective date 2023-01-09 – NL | FR | ENG
ICF Parents-Guardian of Participating Children
- TMP ICF Experiment Parents-Guardian of Participating Children – Version 3.1 Effective date 2023-02-20 – NL | FR
- TMP ICF Experiment Parents-Guardian of Participating Children – Version 3.0 Effective date 2023-01-09 – ENG
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
- TMP ICF Trials Female Participant who becomes Pregnant – Version 4.0 Effective date 2023-01-09 – NL
- TMP ICF Trials Female Partner who becomes Pregnant of Male Participant – Version 4.0 Effective date 2023-01-09 – NL
Pediatric clinical trials with medicinal product (nl: “Proef’)
ICF Parents-Guardian of Participating Children
- TMP ICF Trials Parents-Guardian of Participating Children – Version 5.1 Effective date 2023-02-20 – NL | FR | ENG
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