sequencing; operations or scientific concerns that impact the sequencing and data return timeline differently at different sites, such as conducting a clinical trial and resourcing of genetic counselors. It was also noted that changing to exomes in the middle alters site strategies and might slow the process overall and increase costs. • Discussion Summary: The CC will create a revised sample flow schedule based upon site accrual rate updates that will still be completed by end of Year 3. ACTION ITEM: Sites will send updated accrual rates to the CC in order to restructure the sequencing timeline. ACTION ITEM: The sequencing centers will update the CC with their throughput. ACTION ITEM: The CC will create a second iteration of the eMERGE Sequencing Flow Timeline. Outcomes Workgroup Report – Hakon Hakonarson, Josh Peterson & Marc Williams • To clarify the information needed in the Outcomes Map that sites are completing, sites should select and measure outcomes for clinically reported variants only and focus on process outcomes, intermediate or surrogate outcomes. The project timeframe is probably not long enough to include clinical outcomes, but those are of interest and could be pursued with other funding. • Approaches to outcome assessment include case series, cohort (most) and randomized controlled trials. The workgroup reviewed a summary of process outcome data categories that suitable for the Outcomes Map. • A conceptual framework presented with returned variants classified by whether they are accompanied by or presage any existing or subsequently developed phenotype evidence. The classifications are mapped to 1 of 5 expected levels of clinical intervention • The workgroup highlighted two additional tracks of research on outcomes – Pediatric-specific Outcomes and Economic Outcomes. Three tentative projects for the pediatrics track include: asthma, TPMT, and developmental outcomes. ACTION ITEM: The CC will help develop a three-tracked agenda and project flow to accommodate the Outcomes Tracks: Clinical Process-related Implementation Outcomes, Pediatrics, and Economics. ACTION ITEM: The Outcomes WG will prioritize phenotype-gene pairs for outcomes data collection. ACTION ITEM: The Outcomes workgroup will design a prototype outcomes evaluation (familial hyperlipidemia, familial colorectal cancer syndromes) ACTION ITEM: The Outcomes WG will consider cascade testing as an approach to expand sample size and power of analyses. Return of Results / ELSI Workgroup Report – Ingrid Holm & Iftikhar Kullo • Research projects proposed by this WG: 1) develop and publish standards for ROR for eMERGE, 2) generate a joint publication with the Clinical Annotations workgroup regarding eMERGE process and criteria for actionability of variants for return, 3) provide an overview of approaches to return of results at each site, and4) develop a repository of standard survey and other psychosocial data collection instruments, potentially accessed online via REDCap. • The concept sheet, “Approaches to Returning Clinically Actionable Results from Next Generation Sequencing Panel in a Health Population,” was discussed, and its focus on developing infrastructure for clinically contextualizing variant results for large populations through site developed algorithms and its value as a collaboration between the