ERKReg Data Access Requests

The ERKReg Board has implemented a comprehensive data access policy that governs data use, ensuring high standards of security, privacy, and integrity. For innovative research purposes, interested parties can request access to ERKReg’s data by following the outlined policy. Access is granted based on the individual’s role and demonstrated need, with necessary security clearances for sensitive information. This policy ensures responsible data use while fostering advancements in research.

Requests undergo a formal review process. Please review carefully the policy below and submit your request here: https://de.surveymonkey.com/r/KPLP9PV

If you have questions, please contact erkreg(at)erknet.org.

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Role-based access rules

Access of authorized users to the registry is controlled by assignment of a secure, individualized password. A hierarchical access authorization system is implemented.
 

Project Management Team (‘super-administrator’)

This group will have access to the global database.

Sub-Registry Leads

(‘sub-administrator’)

This group will have access to all patient level anonymized data in the associated sub-registry.

Center users

This group will have access to their own center´s data.

Investigators

This group may propose analyses of registry data by submitting an Analysis Request Form for review and approval by the Data access committee.

Eligibility criteria for data access requestors


Investigators of active contributing units (having enrolled at least 50 patients in total and 3% of the enrolled population of interest+ clear scientific interest and expertise) or external investigators with an active ERKReg collaborator (fulfilling the same rules) are entitled to request data analyses.

Data Access Procedure

  • The requestor shall need to complete the survey “Data Access Form/Registry Analysis Concept Sheet”
  • The completed form shall be submitted to the ERKReg Project Management Team which will check the compliance with the formal requirements and forward the request to the Data Access Committee (link to website).
  • The Data Access Committee shall provide their feedback using the Feedback Form within 6 weeks from initial application.
  • Data access is granted when 75% agreement has been reached.
  • In case of competing applications, the investigators will be informed and encouraged to join their applications.
  • The principles of data sharing for different stakeholders are described in the table below
  • Prior to the sharing of any data, a Data Transfer Agreement (DTA) including a confidentiality statement must be executed to ensure the protection and proper handling of all shared information

             Stakeholder

Data to be shared

Highest data level

Access Modality

ERKReg researcher

all available data

Pseudonymized data

Free of charge

academic researcher with ERKNet affiliation

CDE+

selected data

Anonymized data

Free of charge

In collaboration with ERKReg collaborator

academic researcher without ERKNet affiliation

CDE+

selected data

Anonymized data

Fees may apply

In collaboration with ERKReg collaborator

Industry researcher

CDE + selected data

Anonymized or aggregated data

Fees apply

National health authority

CDE only

Aggregated data

Free of charge

Regulatory authority (EMA)

CDE only

Aggregated data

Free of charge

Patient organisation, NGO

CDE only

Aggregated data

Fees apply

HTA / Insurance companies ...§

CDE only

Aggregated data

Fees apply

Explanations:

What does CDE mean?

The Joint Research Centre (JRC) of the European Commission has developed Common Data Elements (CDEs) aiming to increase interoperability of rare disease registries.

Please find the set of CDE at:

https://eu-rd-platform.jrc.ec.europa.eu/system/files/public/CDS/EU_RD_Platform_CDS_Final.pdf

 

What does “anonymized data” mean?

Definition: Data from which all personally identifiable information has been removed or altered in such a way that individuals cannot be identified by any means, either directly or indirectly. Anonymization involves deleting details such as dates, centre and countries information, patient identifier, ERKReg identifier.

Re-identification: Anonymization is intended to be irreversible, meaning there should be no way to re-identify the individuals from the anonymized data.

 

What does “pseudonymized data” mean?

Definition: Data where personally identifiable information has been replaced with pseudonyms or codes. However, the original information is kept separately and securely, allowing for potential re-identification if necessary.

Re-identification: Pseudonymization is reversible, meaning that it is possible to re-identify individuals if you have access to the key or information that links the pseudonyms to the original data.

 

What does “aggregated data” mean?

Definition: Aggregated data includes statistics like averages, counts, percentages, and rates, and excludes personally identifiable information to ensure confidentiality.

 

updated: 19.08.2024

Data Access Committee

The data access committee is composed of different members, depending on the type of data requested. A doube majority is needed for approval. For subregistry related data, subregistry leads will have the power to veto. 

 

For global and non-specific requests

 

  • ERKReg Board without representatives of ERA and ESPN
  • 3 largest contributing centres related to the population of interest. The respective centre leads, or a delegated person will be considered.

 

 

For disease/disease-group specific requests

 

  • 1 ERKReg Board chair
  • 1 ERKReg Board member for the disease/disease group of interest
  • 1 ePAG for the disease/disease group of interest
  • 3 chairs of the respective ERKNet working group
  • 3 largest contributing centres related to the population of interest. The respective centre leads, or a delegated person will be considered.

 

  • For subregistry related data: subregistry leads

 

updated: 19.07.2024