2. 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

3. 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 containing links to multimedia files like images and podcasts

4. (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

5. 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. 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 containing links to multimedia files like images and podcasts 2 4

6. 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

7. 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

8. 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