INTRODUCTION
The American Association for Cancer Research (AACR) Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE) is a multi-phase, multi-year international data sharing project that catalyzes precision oncology through the development of a regulatory grade registry that aggregates and links clinical grade cancer genomic data and clinical outcomes from tens of thousands of cancer patients at multiple international studies.
The project’s approach to data harmonization is such that each participating organization can continue to operate how it best sees fit while simultaneously contributing its data to the project. Participating institutions each provide 500 pancancer CLIA- or ISO-certified genomic records per year of participation and accompanying limited clinical data for each; maintain IRB approval or equivalent; meet data standards and deadlines; participate in meetings, committees, and subcommittees; and execute the Master Participation Agreement, Data Use Agreement, Project Amendments; and agree to all terms. Additionally, each participant agrees to return to the electronic health records (EHRs) of select patients as necessary to gather deeper clinical data as part of various sponsored research projects. Funds to offset costs associated with manual chart abstraction provided and agreed to as part of each project proposal.
Finally, the data within GENIE are made publicly available after defined periods of time; the first released data set is available at www.cbioportal.org/genie/. Your institution must agree to this as part of the Data Use Agreement.
The following survey collects information on the genomic and clinical data enterprise at your institution. In addition to the information included herein, we will require a letter of intent from your institution’s CEO, Cancer Center Director, or equivalent stating your intention to join the consortium and your willingness to agree to our established legal infrastructure without changes to the documents, which are available here:
Steering Committe Resolution: www.aacr.org/Research/Research/Documents/AACR_Project%20GENIE%20Steering%20Committee%20Resolution%2020160509.docx
Data Use Agreement:
www.aacr.org/Research/Research/Documents/redacted_DUA.docx
Master Participation Agreement:
www.aacr.org/Research/Research/Documents/redacted_MPA.docx