Partners Healthcare System, INC

LUNG TRANSPLANT SERVICES

COMPREHENSIVE BRAIN HEALTH AND TRAUMA (COMBHAT) PROGRAM - SOF TBI PILOT PROGRAM

EO-14398-A LONG-TERM VASCULAR MPS TO ASSESS CYCLIC CARDIOVASCULAR TOXICITY OF ONCOLOGY DRUGS

MODELING ANTHRACYCLINE-TRIGGERED VASCULAR DYSFUNCTION

THE SUB PI AND OTHER BWH INVESTIGATORS WILL PARTICIPATE IN TASK A FOR ALL FIVE YEARS OF THE COPDGENE PHASE 4 PROJECT AND WILL PROVIDE KEY CONTRIBUTIONS TO BOTH SPECIFIC AIMS OF THE TECHNICAL PROPOSAL. HE WILL LEAD THE BWH COMPONENT OF THE COPDGENE ADMINISTRATIVE CENTER AS WELL AS THE GENETIC ANALYSIS CENTER. THE OTHER BWH INVESTIGATOR WILL DIRECT THE BIOINFORMATICS CENTER, WHICH WILL PERFORM OMICS DATA ANALYSIS WITH STATISTICAL, MACHINE LEARNING, AND NETWORK APPROACHES. SAN JOSE ESTEPAR WILL LEAD THE BWH COMPONENT OF THE COPDGENE IMAGING CENTER, WHICH WILL FOCUS ON LOCAL EMPHYSEMA PROGRESSION AND COMORBIDITY (CARDIAC, PULMONARY VASCULAR, AND PECTORALIS MUSCLE) MEASURES IN COPDGENE CT SCANS. NWH INVESTIGATORS WILL CONTINUE TO CO-LEAD THE COPDGENE SUBTYPING CENTER. THE COPDGENE BIOREPOSITORY STAFF AT BWH WILL WORK WITH BWH INVESTIGATORS TO PROVIDE QUALITY-CONTROLLED GENOMIC AND MOLECULAR DATA FROM COPDGENE BIOSPECIMENS COLLECTED DURING ALL STUDY VISITS. THE LEAD PI AND THE BWH CO-INVESTIGATORS WILL PARTICIPATE IN MULTIPLE WEEKLY CALLS AND REGULAR COPDGENE INVESTIGATOR MEETINGS TO DISCUSS TASK A ACTIVITIES.

HARVARD UNIVERSITY FUNDS EFFORT FOR SMART IRB AMBASSADORS AT SEVERAL PARTICIPATING CTSA HUBS (VIA SUBAWARDS). THE AMBASSADOR WILL ENSURE REGIONAL COVERAGE AND WILL SERVE AS THE PRIMARY RESOURCE FOR TRAINING TO LOCALLY IMPLEMENT THE SMART IRB AGREEMENT AND SOPS AND TO ASSIST IN THE DISSEMINATION, IMPLEMENTATION AND HARMONIZATION OF THE SMART IRB MODEL ACROSS CTSA HUBS AND THEIR AFFILIATES. THIS APPROACH PROVIDES AN OPPORTUNITY FOR ALL TO PARTICIPATE IN THE ONGOING DEVELOPMENT OF SMART IRB, AND FULLY LEVERAGES EXPERTISE ACROSS THE NCATS CONSORTIUM. IT IS EXPECTED THAT THE AMBASSADOR WILL: €¢ UNDERGO AN IN-PERSON TRAINING BY MEMBERS OF THE SMART IRB EXECUTIVE COMMITTEE TO LEARN ABOUT THE SMART IRB MODEL AND ROLE AS AMBASSADOR €¢ WORK WITH THE SMART IRB REGULATORY TEAM LEADS TO PRIORITIZE ACTIVITIES AND ASSIGNMENTS €¢ WORK WITH ASSIGNED CTSA HUBS AND AFFILIATES TO SIGN THEM ONTO THE SMART IRB AGREEMENT €¢ EDUCATE CTSA HUBS ON THE SMART IRB MODEL (INCLUDING THE AGREEMENT, SOPS, AND WORKFLOWS) VIA GROUP WEBINARS AND INDIVIDUALIZED SESSIONS €¢ PARTICIPATE IN BIWEEKLY TO MONTHLY CALLS TO PROVIDE UPDATES ON PROGRESS AND SHARE STRATEGIES TO ADDRESS ISSUES RELATED TO THE ADOPTION OF THE SMART IRB MODEL OR SINGLE IRB REVIEW €¢ HELP TROUBLESHOOT ANY PROBLEMS INSTITUTIONS EXPERIENCE SIGNING ONTO AND OPERATIONALIZING THE SMART IRB AGREEMENT, WHICH COULD INCLUDE WORKING WITH THE SMART IRB EXECUTIVE COMMITTEE AND NCATS FOR ASSISTANCE €¢ ASSIST IN THE DEVELOPMENT OF AND PROVIDE FEEDBACK REGARDING MATERIALS AND WORKFLOWS THAT SUPPORT SINGLE IRB REVIEW, TO BE SHARED WITH CTSA HUBS VIA THE SMART IRB WEBSITE AND OTHER MECHANISMS €¢ ACT AS A €œHELP DESK€Ͽ½ FOR QUESTIONS RECEIVED VIA THE SMART IRB WEBSITE €¢ PARTICIPATE IN THE DESIGN AND APPLICATION OF THE FACILITATION SERVICE AS REQUIRED €¢ PROVIDE FEEDBACK TO THE SMART IRB INFORMATICS GROUP REGARDING WORKFLOWS FOR AND USER ACCEPTANCE OF IT PLATFORMS DEVELOPED TO SUPPORT JOINING THE SMART IRB MASTER AGREEMENT AND RELIANT REVIEW PROCESS €¢ ASSIST THE SMART IRB EXECUTIVE COMMITTEE, AS NEEDED, IN THE UTILIZATION OF THE SMART IRB MODEL IN AT LEAST 2 MULTISITE CTSA PROGRAM CLINICAL STUDIES TO PILOT SMART IRB TOOLS €¢ PARTICIPATE IN SMART IRB EFFORTS TO HARMONIZE POLICIES, PROCESSES AND TERMS OF ART RELATED TO IRB RELIANCE

R&D-SCHOOLS, NON-MIT