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Clinical Research Resources SOM New Faculty Orientation August 2017 Pamela G. Terry, MBA, JM Associate Executive Director,

University Resources ACTSI Atlanta Clinical & Translational Science Institute CRN Clinical Research Network ResearchMatch Clinical Trials Audit & Compliance Emory Integrated Core Facilities Library & Information Technology Services

Library & Information Technology Services Clinical Trials Website (www.clinicaltrials.emory.edu) Clinical Trial Dashboard in Tableau Emory First (faculty info on research, scholarship & teaching) i2b2 (query EeMR for study feasibility) For more services, see it.emory.edu/catalog/data-andreporting/index.html

Clinical Trials Dashboard 5

Clinical Trials Dashboard 6

Office of Research Administration Resources Conflict of Interest Environmental Health & Safety Institutional Animal Care & Use Committee Institutional Review Board Office of Sponsored Programs Office of Technology Transfer Research Administration Services More information available at www.ora.emory.edu

OCR Quarterly Scorecard Department # Studies Total Business Days (mean/median) Department of Medicine Cardiology (4) Endocrinology (1) Infectious Disease (4) Nephrology (1) Otolarynology (1) Pulmonary (3) Rheumatology (2) Department of Surgery General Surgery (1) Transplantation (1) OCR Receipt - OCR EPEX Approval OTT Receipt - Negotiations Complete * EPEX Receipt - enoa enoa - FPFV IRB Receipt IRB Approval IRB Approval - FPFV 16 25/22 29/32 37/37 Pending 38/43 Pending 49/56 2 30/30 Pending Pending Pending 18/18 Pending 11/11 Dermatology 3 Pending Pending/UA Pending/UA Pending 32/32 Pending 53/53 Hematology/Oncology 14 22/24 11/4 Pending Pending 27/23 Pending 22/12 Neurology 8 21/25 27/35 Pending Pending 12/12 Pending 46/29 Ophthalmology 2 Pending Pending/UA Pending/UA Pending Pending Pending 43/43 Orthopedics 2 16/16 36/36 Pending Pending 28/28 Pending 43/43 Pathology/Laboratory Med 3 Pending Pending/UA Pending/ UA Pending Pending Pending 43/43 Psychiatry 1 Pending Pending Pending Pending Pending Pending 38/38 Urology 1 33/33 Pending Pending Pending Pending Pending 34/34 Total # Studies 52 Total Business Days 24/33 25/31 37/37 Pending 28/32 Pending 38/49 Total Median Calendar Days 46 38 50 Pending 43 Pending 67 EPEX Rcpt Date- Quarter End Date

ClinicalTrials.gov Problem Log As of 07.31.2017: Total Number of Records: 846; Problems Detected: 51 problems in 29 records

Study Specific Reports

Departmental Resources Department Chair/Division Director Vice Chair for Research Research Administrator Senior Mentor DOM Hitchhiker s Guide to navigating mandatory research compliance & approvals (medicine.emory.edu/research/internal-researchresources/hitchhikers-guide/) Aware of departmental specific policies, procedures, and resources.

Contacts Robin C. Ginn, Executive Director rginn@emory.edu (404) 778-2977 Pam Terry, Associate Executive Director, Pre-award pgterry@emory.edu (404) 778-2973 Sherry Coleman, Associate Director, Clinical Research Support Services sherry.coleman@emory.edu (404) 727-4371 Vickie Swafford, Associate Director, Data Integration & Integrity vswaffo@emory.edu (404) 778-4521 Michelle Robinson, Associate Director, Clinical Research Finance Mgmt michelle.r.robinson@emory.edu (404) 712-7260 Bridget Strong, Director, Education & Outreach bstrong@emory.edu (404) 778-2975 OCR Website: www.ocr.emory.edu