Clinical Research Data & System Strategy Session

1. Clinical Research Data & System Strategy Session Michael Kamerick, Sr. Director of Health Systems Solutions, Recombinant Systems Diana Gumas, Director of Clinical and Clinical Research IT

2. Goals for Today’s Session • Understand our current state with regards to clinical research enterprise systems • Learn what other institutions have done to leverage their clinical research enterprise systems • Develop a strategy for clinical research enterprise system data contents and interfaces

3. Current State

4. What are others doing? UMass – cohort discovery + finding samples in biobank based on clinical phenotype City of Hope – integrate i2b2 with tissue repository Cincinnati Children’s – Liver transplant registry, cohort discovery Thomas Jefferson – i2b2 linked with tumor registry & biospecimen repository Harvard / Mass General – use i2b2 for EHR driven genomic research in numerous disease categories Harvard/Partners - rheumatoid arthritis phenotypes using diagnosis codes & NLP of documents Insights from Michael Kamerick…

5. High Level Points from Today’s Discussion • Establish a “Data Trust” and associate governance, to be led by Dr. Peter Greene with help from Recombinant • Limit data in caTissue to specimen metadata and limited clinical annotation. TBD as to what limits are reasonable • To make #2 work, need to be able to spin off as needed protocol-specific data marts for clinical data that researchers are entitled to. • Need for permissions registry • Use of i2b2 to find tissues associated with a clinical phenotype • (FUTURE) Use of i2b2 to find genotype associated with clinical phenotype • Data repository should be in FISMA-controlled environment • Labeling data as research data if in the clinical record • Need to more easily access image data from multiple sources