Templates clinical studies

ICF Interventional Study

TMP ICF Experiment Adults – Version 2 Publication date 2025-01-01 – NL | FR | ENG

ICF Short Version Prospective Observational Study

TMP ICF Experiment Short Version Prospective Observational Study – Version 2 Publication date 2025-01-01 – 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 and/or as data may be used for commercial purposes and partners, explicit consent of the participant is needed.
  In that case the template ICF Retrospective Study Adults should be used:

TMP ICF Retrospective Study Adults – Version 2 Publication date 2025-01-01 – NL | FR | ENG

• Ghent University Hospital aims to inform its patients as much as possible regarding the use of their data via the patient portal and/or an information letter.
  The template Information Letter Retrospective Study Adults can be used:

TMP Information Letter Retrospective Study Adults – Version 2 Publication date 2025-01-01 – NL | FR | ENG

ICF Experiment Parents-Guardian of Participating Children

TMP ICF Experiment Parents-Guardian of Participating Children – Version 2 Publication date 2025-01-01 – NL | FR | ENG

ICF Experiment Children aged 12-17 years

TMP ICF Experiment Children 12-17 years – Version 2 Publication date 2025-01-01 – NL | FR | ENG

Clinical trials with medicinal product (nl: “Proef’)

ICF Adults Patients

Model ICF for Interventional Clinical Trials with IMP on adult patients – FAMHP – NL | FR | ENG

ICF Healthy Adult Volunteers

Model ICF for Interventional Clinical Trials with IMP in healthy adult participants – FAMHP – NL | FR | ENG

ICF Pregnancy follow-up during and/or after the trial

TMP ICF Trials Female Participant who becomes Pregnant – Version 1 Publication date 2023-11-02 – NL
TMP ICF Trials Female Partner who becomes Pregnant of Male Participant – Version 1 Publication date 2023-11-02 – NL

Pediatric clinical trials with medicinal product (nl: “Proef’)

ICF Children aged 8-11 years

TMP ICF Trials Children 8-11 years – Version 1 Publication date 2023-11-02 – NL | FR | ENG

ICF Children aged 12-17 years

TMP ICF Trials Children 12-17 years – Version 1 Publication date 2023-11-02 – NL | FR | ENG

Other templates clinical trials with medicinal product (nl: “Proef’)

Study Protocol

TMP Clinical Study Protocol CTR – Version 2 Publication date 2024-10-18 – ENG

Study Protocol Synopsis

TMP Clinical Study Protocol Synopsis CTR – Version 1 Publication date 2024-10-11 – NL | FR | GER | 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 2 Publication date 2024-09-06 – ENG

Medical device trials

ICF Adults

Model ICF for clinical investigations with medical device – FAMHP – NL | FR | ENG

Clinical Investigation Plan

TMP Clinical Investigation Plan for medical device trials – Version 2 Publication date 2024-06-14 – ENG

Clinical Investigation Plan Synopsis

TMP Clinical Investigation Plan Synopsis for medical device trials – Version 1 Publication date 2024-06-14 – NL | ENG

Serious Adverse Event Form

FRM SAE for medical device trials – Version 2 Publication date 2024-07-15 – ENG