FINPEDMED has created various materials to help support and serve pediatric clinical trials.
The general Informed Consent Form and Patient Information document templates can be used in various type of clinical trials conducted in Finland. Picture Cards can be used for multiple purposes as a visual support, e.g. for discussion with people from different cultural backgrounds accross various customer-related work. All Informed Consent and Patient Information document templates need to be modified according to the trial protocol in case.
- Guidelines and a Table of important facts for investigators and sponsors to be used in Informed Consent process design (available only in Finnish)
- Document templates for Informed Consent and Patient Information for all pediatric age groups; Informed Consent template for minors (under 15-years of age) contains integrated patient information
- Patient Information template (index) for 15 to 17-year-old adolescents
- Information leaflet on the processing of personal data (Appendix to the consent form for 15-17-year-olds)
- Notification of Participation template to guardians of 15 to 17-year-old children
- Maternal Informed Consent Form template for pregnant women
- Picture Cards for pediatric clinical trials and clinical practice: support material
All materials (other than guidelines) are available in English, Swedish, and Finnish. See more: Resources; Document templates and Picture cards.