EudraCT
For interventional study drug clinical trials (EudraCT-studies) in adult patients, use this national template. An initial version of this template was published on July 1, 2019, and a new version is now available. This version was published on the BAREC website on July 25, 2024. This template was designed by the BAREC ICF Working Group.
The sponsor statement also needs to be entered and submitted.
Template EudraCT-studies UZ Leuven sponsor
When a study is submitted with diagnostic radiopharmaceuticals (PET/SPECT imaging), the text in the document below should be included in the study's ICF.
Please include in the ICF under section 13, "Who reviewed and approved the documents related to the study," that the study has been approved by the Federal Agency for Nuclear Control (FANC) when working with radiopharmaceuticals. It is important that the patient is informed that the FANC has granted approval and that the patient can contact them with any questions.
Template for interventional clinical studies with an investigational vaccine in adult healthy volunteers
A template for interventional clinical studies with an investigational vaccine in adult healthy volunteers can be found here in Dutch, French and English.
You will also find additional guidelines for use of this template in a PowerPoin tas well as a template for drawing up a sponsorship statement on the CT-college website. https://consultativebodies.health.belgium.be/en/documents/model-icf-vaccine-trials-adult-healthy-volunteers
Template for clinical investigations with a medical device in adult patients
For clinical investigations with a medical device (MDR-studies) in adult patients, use this national template. This template was published on the BAREC website on July 25, 2024. This template was designed by the BAREC MDR Working Group in cooperation with the ICF Working Group.
Template for clinical investigation with a medical device UZ Leuven sponsor
Non-EudraCT
For non-EudraCT studies use the templates below (ZIP-file with versions in Dutch, English and French).
Please use the "UZ Leuven sponsor" templates if UZ Leuven is the sponsor of your study. These templates already take into account the legal basis chosen by UZ Leuven to process data ("general interest", cf. article 6 of the General Data Protection Regulation (GDPR)), the contact details of the insurance company are entered, etc.
For studies where KU Leuven is the sponsor, the "UZ Leuven sponsor" template can also be a good guideline as for most KU Leuven studies, "general interest" is also chosen as the processing basis.
Templates non-EudraCT studies
These documents are meant for adult patients.
Information letter
To draw up an information letter for research that does not collect personal data, we recommend using this template to inform individuals about the study.
Guidelines for drawing up ICF
For additional guidelines for drawing up/entering a ICF, we refer to the following documents:
The latter document describes the limitations that need to be taken into account when using electronic methods to inform a potential participant about a clinical trial and/or to get the ICF signed.