Patient Information Folder / Informed Consent

In the Core Registry personal patient information is collected. Therefore, informed consent is required from the patient, along with ethics approval from the centre entering the data. In the tabel below, you can find templates and approved Patient Information Folders (PIFs) with an Informed Consent Form (ICF). We provide versions for 4 different age groups: adults, children aged 12-16 years, adolescents aged 16-18 years, and a parent version.

Templates

We have created templates in various languages. These templates are intended purely as a starting point and can be fully customised to meet your centre’s or country’s local legislation and the specific requirements of your hospital’s ethics committee in order to obtain ethics approval from your legal department. We are working on adding more language options. If your language is not yet included in the tabel below, please contact us and we may be able to provide you with a template. 

Approved PIFs/ICFs

We also provide examples of approved PIFs/ICFs. These documents have been approved only by the centre or country as indicated in the document, taking the specific local and/or country legislation into account. Therefore, these PIFs/ICFs are NOT legal documents for other centres or countries, as specified in the document, but can be used togteher with the templates to customize to meet your centre’s/country’s ethics requirements to get ethics approval.

Disclaimer                                                          

The most up-to-date version of the PIF templates are the English and Dutch. Other languages may differ slightly from these. Please check the most recent changes in our Dutch and English templates by using the option: Review – Track Changes – All Markup. The date of the latest update is shown in the footer of each template. You can always contact us to check whether any updates are required for your version at registries@lumc.nl.