H2020 SME 672570 — MammaPrint

Data Management Plan 31 AUG 2015

_Analysis:_

The tumor samples (FFPE blocks or slides) will be shipped to Agendia for
MammaPrint analysis purposes. The West German Study Group (WSG) will provide
the clinical and pathological information necessary for the execution of the
trial.

_Archival:_

Any remaining material will be returned to WSG Biobank in Hannover (Germany)
at the end of the project.

#  Data storage at Agendia

Every step of the research process, from data collection to data
transformations, variable creation and the final analyses, is documented and
stored in a secure centralized location.

Data in the EDC is stored on the web-server in a secure database, which is
replicated for backup purposes. Data sent to, and retrieved, from the web-
servers is encrypted using SSL (Secure Sockets Layer) if so required. Only the
principle investigators and the ICT Director and Operations Director at the
company responsible for creating and maintaining the study database will have
access to the data entered. All externally involved individuals have executed
a Confidentiality Agreement to ensure that data is kept private.

The MammaPrint index data, the result of the genomic profile analysis, are
stored in a secure database according to the applicable SOP’s that are in
place at Agendia.

Procedures with respect to electronic data storage, managing and monitoring
access control, systems and password security and backup procedures have been
written to ensure data integrity.

From the data warehouse datasets will be made available for statistical
analysis which will be performed by Agendia.

#  Data accessibility

The gene expression profile data , translated into a MammaPrint index,
obtained for each patient in the four clinical trials, together with the
clinical pathological information, are the source data for peer reviewed
publications in (inter)national journals, presentations on congresses and
symposia.

The algorithm to translate the microarray results into a MammaPrint index is
proprietary and cannot be accessed or shared with others.

Related to the strategy for knowledge management and protection, Agendia will
give open access to the scientific publications through open access
publishing.

Where allowed by the academic partner or collaborator the data collected will
be open for other research groups. Any qualified researcher who is interested
in using the MammaPrint project data may apply for access by a proposal. The
applications need to be reviewed and approved by Agendia.

Agendia NV ● Science Park 406 ● 1098 XH Amsterdam ● The Netherlands phone +31
20 4621500 ● fax +31 20 4621505 ● info@agendia.com ● www.agendia.com

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H2020 SME 672570 — MammaPrint

Data Management Plan 31 AUG 2015

#  Data archiving

All data generated during the course of the projects will be stored according
to the applicable SOP’s and Compliance Manual that are in place at Agendia.

Procedures have been written on retention of records and materials, electronic
data storage, backup procedures and electronic, paper and study material
archiving.

At the end of the project all data will be integrated in a data warehouse.
Before the EDC and clinical database is closed, closure checks and a quality
assurance audit will be performed to verify the integrity and completion of
the data collected and assure data quality.

Agendia NV ● Science Park 406 ● 1098 XH Amsterdam ● The Netherlands phone +31
20 4621500 ● fax +31 20 4621505 ● info@agendia.com ● www.agendia.com

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