E1/E2. Subject information sheet and informed consent form subjects
To speed up the assessment process of the Subject Information Sheet (SIS) and Informed Consent Form (ICF), you are strongly advised to use (one of) the templates for adults and/or children (in Dutch). These templates have been developed to assist investigators in compiling concise, clear information and prevent omission of essential parts when drafting the sheet.
Please note: The templates are updated regularly. At all times, use the most recent versions of the templates as available on this website.
- Template Subject Information Sheet for research subjects <16 years of age (children)
- Template Subject Information Sheet for research subjects > 16 years of age (adults)
- Questions and answers on the data section of the template Subject Information Sheet for research subjects > 16 years of age (adults)