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 examples of 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 that can be customized to meet your centre’s or country’s ethics committee requirements in order to obtain ethics approval by 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.Â
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 are NOT legal documents in other centres or countries.
| Language | Templates for you to customize to meet your local ethics requirements | Approved PIF's/ICF's ONLY for the centre or country as mentioned in the document | ||||||
|---|---|---|---|---|---|---|---|---|
| Austrian | Adult | Child 12-16 | Child 16-18 | Parent | ||||
| Czech | - | - | Child 16-18 | - | Adult PIF | Adult ICF | Child | |
| Dutch | Adult | Child 12-16 | Child 16-18 | Parent | Adult | Child 12-16 | Child 16-18 | Parent |
| English | Adult | Child 12-16 | Child 16-18 | Parent | Adult & 14+ | Child 14- | ||
| French | soon! | Adult | ||||||
| German | Adult | Child 12-16 | Child 16-18 | Parent | ||||
| Greek | Adult | Child 12-16 | Child 16-18 | Parent | Adult | |||
| Italian | Adult | Child 12-16 | Child 16-18 | Parent | ||||
| Portuguese | Adult | Child 12-16 | Child 16-18 | Parent | ||||
| Spanish | Adult | Child 12-16 | Child 16-18 | Parent | Adult PIF | Adult ICF | Child PIF | |
| Ukrainian | Adult | Child 12-16 | Child 16-18 | Parent | ||||
| Turkish | soon! | |||||||
As mentioned before the approved PIFs/ICFs are NOT legal documents for other centres/countries as specified in the document, 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.