GENOMatch – IT Infrastructure for the Protection of Patient Data

GENOMatch GENOMatch University Technology

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GENOMatch comprises a complete IT infrastructure for the protection of personal data in pharmacogenetic studies. GENOMatch is a validated internet application in accordance with 21 CFR Part 11 and GCP.

 

Field of Application: Pharmacogenetic Research

Pharmacogenetic research is concerned with the identification of genetic markers that influence both tolerance and effectiveness of a given preparation – with a long-term goal to optimize patient medication. For this purpose, data from clinical assessments need to be correlated with genetic data from study participants and patients. Personal genetic data is understood to be especially worthy of protection in the public eye and its handling requires a high degree of sensitivity from people and machines. The biobank GENOMatch fulfills these requirements and allows for merging and scientifically analyzing clinical and genetic data which has been pseudonymized multiple times.

 

The Basis for Biobanking

GENOMatch supports worldwide logistics with respect to pharmacogenetic samples as well as the consequently required administration of biobanks. GENOMatch achieves an optimal balance between needs for protecting the genetic information of participants in pharmacogenetic studies and scientific demands for an exacting correlation of clinical study data and genetic information.

This requirement is attained through the strict management of roles and access rights within GENOMatch, a division of responsibilities between several institutions, and a spatial and organizational separation of user groups. Data storage takes place in an independent data center (SIM Center).

Incoming samples are registered in the logistics center (Central Sample Repository) and pseudonymized multiple times at different instances. Samples in long-term storage can no longer be traced back to the patient at the logistics center (factual anonymization).

Personal identifiers of patients/study participants who have consented to genetic analysis are pseudonymized by the implementing institute via a 2-stage-filter (web service) and matched against the SIM center data. With this technology, genetic and clinical data can be analyzed in factually anonymized form by scientists in a secure environment .

All data transfers are carried out in encrypted form and all pseudonymization chains are encrypted before storage in the database.

GENOMatch has been audited and certified by the Independent State Center for Data Protection Schleswig-Holstein (http://www.datenschutzzentrum.de/audit/kurzgutachten/a0303/index.htm).

 

Quotes from the Data Protection Reviewer

“The devised pseudonymization process guarantees a level of security that exceeds current practices thus setting a new standard.“

“The submitted data protection management system ensures sustained data protection also in the long-run.“

“The internally logical and thorough conceptualization is suited to strengthen trust on behalf of study participants in the long-term protection of their personal data.“

 

The Best for Last

Tembit won the Open Source Best Practice Award for the development of GENOMatch.