GENOMatch - IT infrastructure for the protection of patient data

GENOMatch is a complete IT infrastructure for the protection of personal data within pharmacogenetic trials.

Field: pharmacogenetic research

Pharmacogenetic research examines genetic characteristics that influence a medication’s tolerability and efficacy. The long-term objective is to optimize individual medication for patients. Therefore, data from clinical trials must be correlated against genomic data from patients of those studies.

The public opinion on the protection of personal genetic data is particularly sensitive and therefore requires a high degree of sensibility and circumspection from man and machine. The product GENOMatch guarantees that these requirements are met and facilitates the matching and scientific analysis of clinical and genetic data throughout multiple pseudonymization procedures.

The basis for Biobanking

GENOMatch supports both the world-wide logistics for pharmacogenetic samples and the Biobank administration required. GENOMatch is designed to achieve an optimal balance between the protection of genetic data of volunteers participating in pharmacogenetic trials on the one hand and the scientific requirements of the researcher to link clinical and genetic data as accurately as possible on the other.

This is achieved through strict role and access management within GENOMatch, which spreads the responsibilities over several institutions and separates the user groups both physically and organizationally

All data is stored in the Secure Identity Management Center (SIM Center), a server hosted by an independent data processing center,.

Incoming samples are checked in at the Logistic Center (Central Sample Repository) and pseudonymized in several steps by different departments. Samples stored in the Logistic Center cannot be associated to the relevant patient (factual anonymization).

A two step filter provides the correct data match between clinical and genomic data from the SIM-Center.

This technology makes it possible for a scientist to analyze factually anonymized genetic and clinical data. All data analyses of pseudomyzed data are only executable in an access-controlled room the “Secure Data Area".

All data is transferred in encrypted form and all pseudonymization chains are stored and additionally encrypted in the database.

The GENOMatch concept has been approved and certified by the Landeszentrum für Datenschutz Schleswig-Holstein (independent Center for Data Protection).

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GENOMatch is used by Bayer Schering Pharma, Corporate Pharmacogenomics.

Some excerpts from the Data Protection Commissioner’s Report:

"The existing concept of the CAU [i.e. Christian Albrechts University, Kiel] for a data processing structure for secure pseudonym storage and safekeeping of blood and tissue samples for genetic analysis usage fulfils the legal requirements of data protection and data security. The envisioned pseudonym process guarantees a standard of security which goes beyond the previous methods and which sets a new benchmark. The presented data protection management system also ensures a long-term preservation of the data security."

"The coherent and comprehensive concept is well qualified for upholding the trust of trial subjects with regard to the long term safekeeping of personally derived data in the context of a pharmacogenetic medical research."

Saving the best for last:

On the 28th of September 2004, Tembit Software received the Open Source Best Practice Award 2004 for the development of GENOMatch.