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Patient Information Folder / Informed Consent

Please find approved Patient Information Folders (PIF’s) with an Informed Consent Form (ICF). These PIF’s are only approved by the centre or country as mentioned in the file name taking the specific local and/or country legislation into account. Therefore these PIF’s are NOT legal documents in other centres or countries.

However, we have translated the Dutch approved PIF’s into English to serve as a template with a standard text for you to add or to customize to meet your centre’s/country’s ethics committee requirements in order to get approval by your legal department and get ethics approval.

At the moment we only have English templates and approved PIF’s / ICF’s for different age groups in English, Dutch and Czech. But we are in the process of having the templates in different languages available, coming soon!

Templates PIF’s / ICF’s

English_PIF_ICF_adult (download, 68 KB)
English_PIF_ICF_parents (download, 213 KB)

Approved PIF’s / ICF’s

English PIF/ICF adult & child 14+ (download, 193 KB) valid for all centres in the UK
English PIF/ICF child 14- (download, 318 KB) valid for all centres in the UK
Dutch PIF/ICF adult (download, 303 KB) Leiden University Medical Centre (LUMC) valid only for LUMC
Dutch PIF/ICF adult fillable pdf (download, 2 MB) Leiden University Medical Centre (LUMC) valid only for LUMC
Dutch PIF/ICF child 16-18 years (download, 274 KB) Leiden University Medical Centre (LUMC) valid only for LUMC
Dutch PIF/ICF child 12-16 years (download, 506 KB) Leiden University Medical Centre (LUMC) valid only for LUMC
Dutch PIF/ICF parents (download, 265 KB) Leiden University Medical Centre (LUMC) valid only for LUMC
Czech PIF adult (download, 427 KB) Fakultní nemocnice v Motole valid only for FN Motol
Czech ICF adult (download, 2 MB) Fakultní nemocnice v Motole valid only for FN Motol
Czech PIF child (download, 841 KB) Fakultní nemocnice v Motole

As mentioned before the approved PIF’s are NOT legal documents for other centres/countries as specified in the file name, but can be used together with the templates to customize to meet your centre’s/country’s ethics requirements to get ethics approval.

For more information you can always contact us at registries@lumc.nl.