Templates clinical studies

Clinical Trials without medicinal product (nl: “Experiment)

ICF Adults

  • TMP ICF Experiment Adults – Version 5.0 Effective date 2023-01-09 – NL | FR | ENG

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

  • TMP ICF Experiment Children 12-17 years – Version 4.0 Effective date 2023-01-09 – NL | FR | ENG

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

ICF Adults

  • Model ICF for Interventional Clinical Trials with IMP – FAMHP – NL | FR | ENG

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

  • TMP ICF Trials Children 8-11 years – Version 4.0 Effective date 2023-01-09 – NL | FR | ENG

ICF Children aged 12-17 years

  • TMP ICF Trials Children 12-17 years – Version 5.0 Effective date 2023-01-09 – NL | FR | ENG

ICF Children aged 18 years during the study

  • TMP ICF trials 18 years – Version 4.0 Effective date 2023-01-09 – NL | FR | ENG

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