241949S
THE RECOVER-BIODATA CATALYST DATA GATEWAY (RBDG) -- FORMERLY KNOWN AS THE CLINICAL OBSERVATIONAL DATA REPOSITORY (CODR) -- IS INTENDED TO PROVIDE A SCALABLE, CONFIGURABLE, AND INTEGRATED, CLOUD-BASED REPOSITORY TO FACILITATE THE COLLECTION, ANNOTATION, HARMONIZATION, CURATION, AND SHARING OF CLINICAL DATA GENERATED BY STRUCTURED OBSERVATIONAL STUDIES AND CLINICAL TRIALS, INCLUDING, BUT NOT LIMITED TO, CLINICAL OBSERVATIONS, LAB RESULT DATA, DEMOGRAPHICS, SOCIAL DETERMINANTS OF HEALTH, GENOMIC AND OTHER Ă‚ OMICS DATA. OBJECTIVE 1. DATA CURATION, METADATA, PROVENANCE AND SUSTAINABILITY 1.1 EXTEND BD CATALYST DATA AND METADATA MODELS TO INCLUDE COVID-19, SARS-COV-2 AND PASC RELATED TERMS AND CONCEPTS FROM DRC CORE INDEX. 1.1.1 ESTABLISH A (META)DATA MODEL TASK FORCE TO EXAMINE POSSIBLE (META)DATA MODELS NEEDED TO ADVANCE RECOVER RESEARCH AS A SUBGROUP OF THE BDC DATA RELEASE & MANAGEMENT WORKING GROUP. PRODUCE RFCS FOR EACH RECOMMENDED MODEL AND/OR CHANGE TO THE ECOSYSTEM BEFORE ADOPTION. MAKE AVAILABLE VIA THE REPOSITORY WEBSITE. (RTI, RENCI, SEVEN BRIDGES, HMS, BROAD INSTITUTE, GEN3, N3C) 1.2 EXTEND BD CATALYST TO SUPPORT USDCI AND OMOP DATA MODELS FOR EHR DATA AND RECOVER DATA DICTIONARIES 1.2.1. INVESTIGATE AND UNDERSTAND USDCI, I2B2, LINKML AND OMOP DATA MODELS AND HOW THEY CAN BE APPLIED ON BDCATALYST FOR RECOVER DATA (SEVEN BRIDGES, HMS,GEN3) 1.2.2. CREATE CWL TOOLS FOR TRANSFORMING DATA TO FIT LINKML AND OMOP DATA MODELS. MAKE THESE TOOLS AVAILABLE ON BDCATALYST (SEVEN BRIDGES) 1.3 IMPLEMENT RECOVER COMMON DATA ELEMENTS (CDES) AND DRC HARMONIZED DATA ELEMENTS. (HMS,GEN3) 1.4 ESTABLISH QUALITY ASSURANCE (QA) PROCESSES SPECIFIC TO RECOVER DATA (HMS, GEN3) 1.5 IMPLEMENT LINKAGE OF RECOVER DATA IN BDC TO RECOVER DATA STORED IN THE DRC CORE MASTER INDEX, MOBILE HEALTH, AND DIGITAL PATHOLOGY REPOSITORIES. (HMS, GEN3) 1.6 ENSURE PROVENANCE OF DATA AND METADATA IS MAINTAINED. (HMS, GEN3) 1.7 PROVIDE SUPPORT AND TRAINING TO THE DRC FOR PRIMARY ANALYSIS INCLUDING BYOD AND AZURE BUCKET OR I2B2 CONNECTIONS (SEVEN BRIDGES) 1.7.1 PROVIDE SUPPORT AND TRAINING TO THE DRC (SEVEN BRIDGES, RENCI) 1.8 COLLABORATE WITH THE DRC AND SAS TO ENHANCE THE CURRENT SAS ENVIRONMENT TO MEET EMERGING NEEDS FROM THE DRC AND INVESTIGATORS INCLUDING PROVIDING ADDITIONAL SAS LICENSING AS AGREED BETWEEN SAS, THE NIH AND SEVEN BRIDGES (SEVEN BRIDGES) 1.8.1 EVALUATE RECOVER USE CASES FOR SAS ENVIRONMENT AND DETERMINE NECESSARY PACKAGE (SEVEN BRIDGES) 1.8.2 IMPLEMENT IMPROVEMENTS TO SAS OFFERING ON BDCATALYST POWERED BY SEVEN BRIDGES (SEVEN BRIDGES) 1.9 ADMINISTER WORKSPACE CREATION FOR THE DRC, RECOVER INVESTIGATORS, RECOVER CLINICAL SITES, RECOVER WORKING GROUPS (SEVEN BRIDGES) 1.9.1 ADMINISTER WORKSPACE CREATION FOR THE DRC, RECOVER INVESTIGATORS, RECOVER CLINICAL SITES, RECOVER WORKING GROUPS (SEVEN BRIDGES) OBJECTIVE 2. IMAGING INTEGRATION 2.1 COLLABORATE WITH THE DRC TO COMMUNICATE GUIDS AND PARTICIPANT IDS AMONGST THE DRC, BDC AND THE AMBRA PACS/VNA INCLUDING ENSURING THE GUIDS AND PARTICIPANT IDS ARE EMBEDDED WITHIN DICOM TAGS 2.1.1 FORM AN RECOVER IMAGING WORKING GROUP (RIWG) AND DEVELOP A CHARTER TO FULFILL MILESTONES UNDER ALL RELATED IMAGING INTEGRATION SUB-OBJECTIVES (SUB-OBJECTIVE 1, 2, 4, 5, 6) (RENCI, SEVEN BRIDGES, GEN3, HMS, AMBRA, DRC) 2.1.2 DEVELOP METHODS FOR OBTAINING GUIDS AND PARTICIPANT IDS FROM DRC AND BDC. (RENCI, GEN3, AMBRA, DRC) 2.1.3 DEVELOP METHODS FOR EMBEDDING NEW DICOM TAGS INCLUDING GUIDS AND PARTICIPANT IDS THROUGH AMBRA PACKS VNA SYSTEM. (RENCI, GEN3, AMBRA, DRC) 2.2 COLLABORATE WITH AMBRA TO ENABLE ACCESS TO IMAGES STORED IN THE PACS/VNA FROM WITHIN THE SEVEN BRIDGES PLATFORM, POTENTIALLY WITH A PHASED APPROACH 2.2.1 PHASE 1: HYPERLINKING OF IMAGES FROM BDC TO ACCESS IN AMBRA 2.2.1.1 DESIGN AND IMPLEMENT HYPERLINKING OF IMAGES FROM BDC TO ACCESS IN AMBRA (SEVEN BRIDGES, GEN3, HMS, RENCI) ATTACHMENT 5A STATEMENT OF OBJECTIVES & MILESTONES PAGE 14 OF 39 2.2.2 PHASE 2: API BASED ACCESS TO IMAGES FROM AMBRA 2.2.2.1 DESIGN AND IM
University Of North Carolina At Chapel Hill
Project Grant OT2HL161841
$2.3m 10/7/22 241004S
BACKGROUND CONSISTENT WITH THE PROPOSAL SUBMITTED BY THE AWARDEE ON JULY 30, 2021, THE NIH, DATA RESOURCE CORE (DRC), AND THE AWARDEE SET FORTH THIS STATEMENT OF OBJECTIVES AND MILESTONES TO DEFINE THE SCOPE OF A PARTNERSHIP FOR THE NIH POSTĂ‚ ACUTE SEQUELAE OF SARSĂ‚ COVĂ‚ 2 INFECTION (PASC) INITIATIVE (AKA, RESEARCHING COVID TO ENHANCE RECOVERY; RECOVER). THROUGHOUT THE LIFE OF THIS PARTNERSHIP. THE NIH, DRC AND THE AWARDEE WILL CREATE AND MODIFY OBJECTIVES, MILESTONES AND DELIVERABLES AIMED AT ACHIEVING THE GOALS SET FORTH HEREIN. THESE OBJECTIVES, MILESTONES AND DELIVERABLES MAY BE EXECUTED SEQUENTIALLY OR CONCURRENTLY AS APPROPRIATE AND MUTUALLY AGREED UPON. AS THE MOBILE HEALTH PLATFORM (MHP) FOR THIS INITIATIVE, THE AWARDEE WILL BE EXPECTED TO DEVELOP AND IMPLEMENT A MOBILE HEALTH APPLICATION FOR THE RECOVER INVESTIGATOR CONSORTIUM, COLLECT MOBILE HEALTH DATA ON RECOVER PARTICIPANTS FROM PARTICIPANT OWNED DEVICES, EQUITABLY DISTRIBUTE RECOVER INITIATIVEPROCURED WEARABLE DEVICES, SECURELY TRANSFER DATA TO SPECIFIED DATA REPOSITORIES, PROVIDE PARTICIPANTĂ‚ FRIENDLY AND STUDY ADMINISTRATORĂ‚ FRIENDLY DASHBOARDS, PROVIDE TECHNICAL SUPPORT AND TRAINING RELATED TO THE MHP AND WEARABLE DEVICES TO INVESTIGATOR SITES, AND FACILITATE PARTICIPANT ENGAGEMENT AND RETENTION VIA THE MHP. NIHĂ‚ S VISION FOR THE MOBILE HEALTH PLATFORM (MHP) AND FOR THE DIGITAL HEALTH DATA REPOSITORY (DHDR; SOLICITED THROUGH OTAĂ‚ 21Ă‚ 015D AND RENAMED HEREIN Ă‚ MOBILE HEALTH DATA REPOSITORY,Ă‚ (MHDR) IS THAT BOTH TEAMS WORK CLOSELY TOGETHER AND WITH THE RECOVER INVESTIGATOR CONSORTIUM TO RAPIDLY AND FLEXIBLY DEPLOY, MANAGE, AND GROW A ROBUST, SECURE DIGITAL INFRASTRUCTURE THAT CAN MEET NEARĂ‚ TERM AND LONGĂ‚ TERM NEEDS OF THE INITIATIVE. THE MHP WILL COLLECT PASCĂ‚ RELATED MOBILE HEALTH DATA (E.G., SENSOR, SYMPTOM AND SURVEY DATA, ETC.) FROM PARTICIPANTS AND WILL SHARE THIS DATA WITH THE MHDR AND DRC TO CLEAN, CURATE, CONDUCT QA/QC, STORE, AND PROVIDE ACCESS TO PARTICIPANTS, THE INVESTIGATOR CONSORTIUM AND EXTERNAL RESEARCHERS. THE INFRASTRUCTURE FOR BOTH COMPONENTS WILL HELP PROMOTION RECRUITMENT, ENGAGEMENT, AND RETENTION OF PARTICIPANTS, COLLECTION OF STANDARDIZED INFORMATION FROM PARTICIPANTS, AND WILL MAKE THE DATA AND ITS DERIVATIVES RAPIDLY AVAILABLE TO PARTICIPANTS, OTHER MEMBERS OF THE CONSORTIUM, AND TO THE RESEARCH COMMUNITY WHERE AND WHEN APPROPRIATE. THEREFORE, IT IS VITALLY IMPORTANT THAT THE MHP AND MHDR CAN NIMBLY ADAPT TO THE CHANGING LANDSCAPE OF STUDIES, MEASURES, DATA TYPES, AND NEEDS OF THE INITIATIVE. A. MOBILE HEALTH PLATFORM (MHP) OBJECTIVES 1. DEVELOP AND IMPLEMENT RECOVER MOBILE HEALTH PLATFORM 1.1. THE AWARDEE IS RESPONSIBLE FOR: 1.1.1. ASSISTING WITH MOBILE HEALTH PROTOCOL DEVELOPMENT AND FACILITATING IMPLEMENTATION (IN COLLABORATION WITH THE CSC, DRC, COHORT STUDY INVESTIGATORS, AND PARTICIPANTS AS APPROPRIATE) 1.1.2. CONDUCTING A LANDSCAPE ANALYSIS WITH REQUIRED AND OPTIONAL FEATURES INCLUDING SITEĂ‚ AND STUDYSPECIFIC DESIGN CUSTOMIZATION, DEVICE INTEGRATIONS, ETC. 1.1.3. MAINTAINING INTEGRITY, CONFIDENTIALITY, PRIVACY, AND SECURITY OF PARTICIPANT STUDY DATA COLLECTED THROUGH THE MHP. THE MHP MAY REQUIRE THE CREATION AND MAINTENANCE OF SYSTEM(S) OF RECORD (SOR) TO SECURELY CONTAIN PERSONALLY IDENTIFIABLE INFORMATION (PII). THE SORS WILL ADHERE TO A FEDERAL INFORMATION SECURITY MANAGEMENT ACT (FISMA)Ă‚ MODERATE LEVEL OF SECURITY CONTROLS. SPECIFICALLY, THE MHP WILL: ATTACHMENT 5A STATEMENT OF OBJECTIVES & MILESTONES 1.1.3.1. INCORPORATE EVOLVING DATA SECURITY STANDARDS AND BEST PRACTICES, AS WELL AS CONFORM TO REGULATIONS THAT ENSURE PRIVACY, CONFIDENTIALITY, INTEGRITY, AND SECURITY, PARTICULARLY FOR DATA CAPTURE AND DATA TRANSFER TO OBTAIN AND MAINTAIN A FISMA MODERATE ENVIRONMENT FOR THE DURATION OF THE PROJECT PERIOD. 1.1.3.2. PROVIDE DATA STORAGE THAT COMPLIES WITH THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) AND FISMA STANDARDS AND IS FEDERAL RISK AND AUTHORIZATION MANAGEMENT PROGRAM (FEDRAMP) AUTHORIZED TO ENSURE PRIVACY AND SE
Careevolution LLC
Project Grant OT2HL161841
$1.8m 6/7/22 240110S
Version: January 20, 2022 Contact author: Ray Ebert Contributing authors: Michelle Olive, Lisa Schwartz Longacre, Audie Atienza, Dana Wolff-Hughes, Andrew Weitz, Kevin Heath, Amanda Casper Purpose The purpose of this document is to outline the objectives and deliverables for a "Phase I" Other Transactions Award to CareEvolution (CareEvo) for the Mobile Health Platform (MHP) and to SAGE Bionetworks/University of California San Francisco (SAGE/UCSF) for the Mobile Health Data Repository (MHDR). Period of Performance The period of performance for these awards shall be 11/23/2021 to 01/31/2022. Goals of Phase I The primary goal of Phase I is to develop a Statement of Objectives and Milestones (SOM) for Phase II of the MHP and MHDR awards. These SOMs will include plans and a timeline with specific objectives, deliverables and milestones for implementing the following three capabilities: 1. Capture of mobile health data via wearable sensors. 2. Capture of COVID-19-related symptom data between follow-up visits via mobile applications on user-supplied devices. 3. Deployment of mo bi le REDCap forms on a subset of client-facing forms from the adult protocol eCRFs used for follow-up visits only (excluding forms used for the baseline evaluation visit). Correspondingly, these SOMS will include plans and a timeline with specific objectives, deliverables and milestones for implementing a FISMA Moderate MHDR, if required. Objectives of Phase I 1. In collaboration with the RECOVER Clinical Science Core (CSC) and Data Resource Core (DRC), and based on the protocol developed for the Adult Cohort Study (Including the Pregnancy Cohort), develop objectives, deliverables and milestones for implementing mobile health data capture via wearable sensors. This includes identifying: a. Hardware (sensor) requirements and cost estimates b. Hardware (sensor) acquisition, deployment, training and maintenance plans c. Relevant sensor data to be collected d. Software (application) requirements and cost estimates e. Software (application) deployment, training and maintenance plans f. Participant recruitment, onboarding and retention plans g. Data transmission requirements and cost estimates h. Data acquisition, storage, management, quality control and harmonization requirements and cost estimates i. Privacy protection/management of Pll and PHI 2. To the extent possible within the period of performance, develop objectives, deliverables and milestones for implementing mobile health data capture via wearable sensors for the RECOVER Pediatric Cohort Study. 3. Data acquisition, storage, management, quality control, harmonization, analysis and reporting requirements for the MHDR, as applied to Items 1 and 2 above. 4. In collaboration with the RECOVER Clinical Science Core (CSC) and Data Resource Core (DRC), and based on the protocol developed for the Adult Cohort Study (Including the Pregnancy Cohort), develop objectives, deliverables and milestones for capturing COVID-19-related symptom data between follow-up visits via mobile applications on user-supplied devices. This includes identifying: a. Software (application) requirements and cost estimates b. Software (application) deployment, training and maintenance plans c. Participant recruitment, onboarding and retention plans d. Data transmission requirements and cost estimates e. Data acquisition, storage, management, quality control and harmonization requirements and cost estimates f. Privacy protection/management of Pll and PHI g. Product support and maintenance plans and cost estimates 5. In collaboration with the RECOVER Clinical Science Core (CSC) and Data Resource Core (DRC), and based on the protocol developed for the Adult Cohort Study (Including the Pregnancy Cohort), develop objectives, deliverables and milestones for deployment of mobile REDCap forms on a subset of client-facing forms from the adult protocol eCRFs used for follow-up visits only (excluding forms used for the baseline evaluation visit). This
Sage Bionetworks
Project Grant OT2HL161841
$3.3m 1/4/22