Ethics Approval for European Registries

e-REC

e-REC is approved by the Science Committee of Internal Medicine at the Leiden University Medical Center, the Netherlands and the National Ethics Service and Information Governance authorities in the UK. No identifiable or partially identifiable personal information is captured in e-REC and individual patient consent is not required. The reported data are stored on a secure server in the Leiden University Medical Center, and all information provided is kept in compliance with the General Data Protection Regulation (GDPR 2016/679).

Core Registry

The Core Registry is approved by the Science Committee of Internal Medicine at the Leiden University Medical Center, the Netherlands and the National Ethics Service and Information Governance authorities in the UK.

The information collected by the Core Registry is what is expected to be collected during routine clinical care and may be shared with approved users to perform or develop new research studies. The Patient Information Folder with Informed Consent allow greater patient involvement through functions such as dynamic consent and completion of patient reported outcomes.

The Core Registry does not collect any information on names, addresses and local hospital numbers. Patients can also access their own information in the Core Registry. All information is kept strictly confidential and handled through secure password protected electronic systems and only those who are directly involved with the Registry are able to obtain access. All information is stored on a secure server in the Leiden University Medical Center in compliance with the General Data Protection Regulation (GDPR 2016/679).

Centres that recruit through a process of opt-out consent can specify this when a new record is created. However local approval is required for the Core Registry. If you apply for ethics approval 

Centres seeking local ethics approval are advised to apply for approval of the Core Registry, rather than submitting a separate study application. This helps avoid duplication and ensures that data collection aligns with the existing approved registry framework.

Centres are advised to check if they require local approval at their own centre.

The following list contains documents that may be required by centres for obtaining local ethics approval. Please contact us if you need a document that is not listed here:

* Why are the documents regarding ethics approval only available in Dutch and English?
Our database is based in the Netherlands and has therefore been approved by the Dutch Ethics Committee. We have translated the documents to English for clarity and to use as a reference, since ethical approval legislation differs between countries. Your centre may require local ethics approval before entering data into the Core Registry.