EJP RD and ERICA developed a series customisable template documents that can be used by the European Reference Networks (ERNs) to obtain the consent of the patients to get their data included in the registry (Informed Consent Form) and establish their governance structure (Data Access Policy). Additionally, legal contracts to be used when data is transferred from an HCP to a central registry (Data Sharing Agreement) or from a registry to an external stakeholder (Data Transfer Agreement) are also provided. Please note that before the adoption of any of these templates in your registry, they need to be reviewed by a legal team.
Informed Consent Forms
An Informed Consent Form (ICF) template for the ERNs has been developed in the framework of EJP RD. It is a research targeted ICF that can be adapted at ERN, national and site level and consists of two versions (one for patients and one for parents/legally designated representatives in case of minors or incapacitated subjects). Translated versions are also available in 26 languages.
Data Access Policy
A customisable Data Access Policy template for the ERNs has been developed in the framework of ERICA. It establishes the governance of the registry, covers the composition of the Data Access Committee (DAC) as well as the entire process to be followed for requesting access to the data captured in the registry.
Data Sharing Agreement
In a centralised registry, where all the data collected by an HCP is transferred to a centralised server, a Data Sharing Agreement will be signed between the registry and every HCPs participating in the registry. A customisable Data Sharing Agreement template for the ERNs has been developed in the framework of ERICA and is available below.
Data Transfer Agreement
If the Data Access Committee of a registry decides to grant access to the registry data to a stakeholder, a data transfer agreement will be signed between the registry and the data requestor. A customisable Data Transfer Agreement template for the ERNs has been developed in the framework of ERICA and is available below.