RAPID II Summary Bidirectional mobile platform report system Capable of real time information and analytics Flexible data and analytic cloud platform Production version with ATO by October 2017. Key Resources provided 24/7 system for MCM response Access to variety of electronic data Access to unstructured data/big data Access to clinical networks

DPV - Adverse Event Report Use Case Healthcare Professionals and consumers submit regular and emergency surveillance adverse event reports DPV - Adverse Event Report Use Case 1 2 General Surveillance Emergency Surveillance RAPID External Data (Future) 4 DPV Stakeholders Adverse Event Analytical Tools 5 3 Scott Proestel Robert Levin Samantha Cotter RAPID AE Dashboard & Data Geovisualization 1 Mobile Data Collection: Clinicians, reporters, and patients create general surveillance and emergency surveillance reports 3 Perform Analytics : Utilize RAPID Dashboard, location based data, and Empirica (signal detection) for analysis 5 Obtain External Data: Data will be shared from external sources via web services (ex. HL7 ICSR) and increase the effectiveness of analysis performed using RAPID analytical tools RAPID Heatmap Empirica 2 Data Transferred to FDA: Data is submitted from mobile device and sent over Cellular network or WiFi to FDA GovCloud via web services 4 Response Sent to Reporter: Within 24 hours a targeted response is sent via email containing links to multimedia files like images and podcasts

(ESP) Safety or Clinical data Duke University Medical Center Brigham and Women’s Hospital University of Southern California Hospital University of Maryland Medical Center Trigger examples: influenza order, blood culture order, sputum culture order, CXR order (ESP) Safety or Clinical data Smart on FHIR API Clinical Data Element Profile for Severe Acute Respiratory Infection data elements Secure Data Broker HHS & Booz Allen Hamilton Data Aggregated & De-identified Geolocation, case and site reporting, resource deployment overlay Regulatory-case level or patient level Clinical Registry case level and patient level Visualization layer with streaming data for research case and patient level

Software Enabled Siteless Clinical Trials Use Case Software Enabled Siteless Clinical Trials Infrastructure Software Enabled Siteless Clinical Trials Use Case 1 2 Patient Level Data Operational Aspects Emergency Signals RAPID External Data (Future) 4 Analytical and Decision Making Tools 3 Are there info resources within logistics and drug supply Knowledge of the different programs and how to apply it in the FDA context. Nov – talk about it in principle. Talk to Perrin Cobb – to apply in influenza Then talk to OND and Discovery together – how to operate High level agreement - RAPID design changes – roadmap 10 word sentence – what RAPID can do in unepxected emeergencies info valuable inpt outcomes How is it used in siteless/adaptive clinical trials. Email Perrin – Sarah Connelly – Debra’s group – use case to test all this out. 1 Data Transmission: Direct from patient sensor data, digital biomarkers, protocol design, site selection, pt recruitment, logistics, pt outcome, data mgmt 3 Perform Analytics: Utilize RAPID Dashboard, location based data, and Empirica (signal detection) for analysis 5 Obtain External Data: Data will be shared from external sources via web services (ex. HL7 ICSR) and increase the effectiveness of analysis performed using RAPID analytical tools RAPID Dashboards & Clinical Data Geovisualization Data Transmitted to FDA: Data goes directly to or is submitted from mobile device and sent over Cellular network or WiFi to FDA GovCloud via web services Response Sent to Software or Reporter: Within 24 hours, sometimes sooner a targeted response is sent as a signal or via email containing links to multimedia files like images and podcasts 2 4

Software Enabled Clinical Trials Trial Administration Protocol Design and Review Site Selection and Start-Up Patient Recruitment Operational Management Drug Supply Logistics Patient Level Data Collection Patient and Outcome Data Management Digital Biomarker Collection Virtual Trials

RAPID Capabilities Bidirectional communications (multimedia) Shared data through secured data broker Real time system in a modular design Cloud based to be flexible (AWS) Developing patient outcome data gathering capability Designed to accept diverse data sets

RAPID collaborators OSE, OND, OCET, OCM, OC, OIMT DPV, DMEPA, DRISK, OAP/DAVP NLM/NIH, Center for Biomedical Communications NLM/NIH Special Information Services U.S. Injury and Illness Clinical Trials group (Discovery group) Brigham and Women’s hospital, Duke, USC InVentiv Corp. Booz Allen Hamilton