BBMRI-ERIC Colorectal Cancer Cohort (CRC-Cohort): Data Protection Policy

Colorectal Cancer Cohort (CRC-Cohort) is developed by BBMRI-ERIC, its BBMRI-ERIC Na-
tional/Organisational Nodes, and BBMRI-ERIC partner biobanks. The CRC-Cohort is de-
veloped as a part of the ADOPT BBMRI-ERIC project1 and will become permanent asset
of BBMRI-ERIC research infrastructure after the end of the project in order to enable re-
search to improve treatment of the colorectal cancer. The data collection should provide
broad European coverage and sufficient number of research participants in order to enable
research that was impossible before. The data collection process runs within the ADOPT
BBMRI-ERIC project with the target 10,000 cases are expected to be collected until end of
March 2018. The juridical person liable for establishment and operations of the cohort
is BBMRI-ERIC. Pseudonymized data will be collected from individual partner biobanks
based on a common data model developed and agreed upon within the ADOPT BBMRI-ERIC
project. BBMRI-ERIC will ensure adequate data protection of the centrally collected data.
This document describes data protection measure implemented and is intended for the
data protection authorities supervising contributing partner biobanks and data protection
experts in ethics committees.

   The document is structured as follows. Section 1 summarizes objectives of the CRC-
Cohort, its legal framework and basic organizational aspects. Section 2 describes data col-
lection and integration process, together with measures for quality checking and assurance.
Access modes for the data set are discussed in Section 3. Overview of tools on which imple-
mentation of the CRC-Cohort relies is provided in Section 4. More in-depth discussion of
combination of technical and organizational measures to ensure data security and protect
privacy of the persons contributing their data to CRC-Cohort is provided in Section 5. Risk
analysis based on STRIDE and LINDDUN is available in Section 6. History of the document
is available in Appendix A. Other relevant BBMRI-ERIC documents, and particularly those
that are not (yet) publicly available, are provided as appendices.