ctsa program webinar
TRANSCRIPT
CTSA Program Webinar
Wednesday, June 24, 2020
2:00 PM – 3:00 PM ET
Agenda
2
Time Topic Presenter
2:00 PM – 2:10 PMWelcome
NCATS and CTSA Program UpdatesMichael G. Kurilla, M.D., Ph.D.
2:10 PM – 2:15 PM N3C Update
Ken Gersing, M.D.
Joni Rutter, Ph.D.
NCATS NIH
2:15 PM – 2:50 PMThe All of Us Research Program: Applications for
Population Research
Kelly Gebo, M.D., MPH
NIH Office of the Director
Chief Medical and Scientific Officer
2:50 PM – 2:55 PM CLIC UpdatesDeborah Ossip, Ph.D.
Martin Zand, M.D., Ph.D
3:00 PM Adjourn Michael G. Kurilla, M.D., Ph.D.
CTSA Program Updates
Michael Kurilla
Opportunities & Administrative Updates
4
Active CTSA Program Notices of Special Interest (NOSI) to Address COVID-19 Public Heath Need
• NOT-TR-20-011 / NOT-TR-20-018: Administrative Supplement, Competitive Revision & CCIA Applications (UL1, U24, U01, R21)
• NOT-TR-20-028: Emergency COVID-19 Competitive Revisions & Administrative Supplements (UL1, U24; CARES funds)
• N3C Effort: Provision of clinical data in specified formats to support illness/infection status/surveillance determinations and/or clinical study data (awards antic. to be $50K-$100K TC)
• NOT-TR-20-029: Administrative Supplement Applications (UL1, U24)
• NOTES• Discuss proposed project & appropriate NOSI with Program Officer prior to submission
• As we near the end of the fiscal year we must defer some meritorious applications for FY21 funding considerations
•
NIH Rapid Acceleration of Diagnostics (RADx) Initiative
• Support innovative technologies to make more rapid SARS-CoV-2 tests (in the millions) available in US by late Summer or Fall in support of safe return to normal life
• National call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies
• Technologies, devices, and strategies
• https://www.nih.gov/research-training/medical-research-initiatives/radx
RADx Components
• RADx-Tech: Innovative point-of-care and home-based tests; improve clinical laboratory tests that can directly detect the virus. https://www.nibib.nih.gov/radx-initiative-covid-19-testing/FAQ
• RADx-UP: Understand factors associated with disparities in COVID-19 morbidity and mortality in underserved populations and to lay the foundation to reduce disparities
• RADx-rad: Support new, non-traditional approaches, including rapid detection devices and home-based testing technologies, that address current gaps in COVID-19 testing
• RADx-ATP: Increase testing capacity and throughput by identifying existing and late stage testing platforms for COVID-19 that are far enough advanced to achieve rapid scale-up or expanded geographical placement in a short amount of time; efforts will focus on scaling up technologies and improving existing high-throughput platforms
RADx-UP New Funding Opportunities
• Community-Engaged Research Testing Research Projects Limited Competition Emergency Competitive Revisions NOT-OD-20-121Due: August 7, 2020
• Community-Engaged Research on COVID-19 TestingEmergency Competitive Revisions NOT-OD-20-120Due: August 7, 2020; September 8, 2020
• Social, Ethical, and Behavioral Implications (SEBI) Research on COVID-19 TestingEmergency Competitive Revisions NOT-OD-20-119Due: August 7, 2020; September 8, 2020
• RADx-UP Coordination and Data Collection Center RFA-OD-20-013Due: August 7, 2020
RADx-UP Pre-Application Webinars (NOT-OD-20-131)
• NIH will hold two pre-application webinars
• Friday June 26, 2020 2-4pm EDT
• Wednesday July 1, 2020 3-5pm EDT
• Questions can also be pre-submitted at [email protected]
• Registration is required: https://www.nih.gov/research-training/medical-research-initiatives/radx/events
• Please contact your program officer or the NOSI scientific contacts with questions
New Human Subjects Research: UL1 Pilots & KL2 Projects • Streamlined processes and reduced administrative burdens
• Continue to tweak for speed and efficiency
• Addendum and Instructions for PIs and SOs version 1.0 (posted 04.9.2020) –required beginning May 1, 2020
https://ctsa.ncats.nih.gov/governance-guidelines/guidelines/new-projects-with-human-subjects-research/
Revised Addendum
contains fields
critical to expedite
review and approval
New NIH Requirement for Key Personnel Changes• Notice Number: NOT-OD-20-124
• Release Date: June 11, 2020. Effective for all requests received on or after June 11, 2020
• In addition to the information normally required for these prior approvals:• All NIH recipients are expected to provide safe and healthful working conditions for their employees and foster work
environments conducive to high-quality research, all requests for approval should include a statement as to whether change(s) in PD/PI or Senior/Key Personnel is related to concerns about safety and/or work environments (e.g. due to concerns about harassment, bullying, retaliation, or hostile working conditions).
• If the arrangements proposed by the recipient, including the qualifications of any proposed replacement, are not acceptable to the NIH awarding IC, the grant may be suspended or terminated. If the recipient wishes to terminate the project because it cannot make suitable alternate arrangements, it must notify the GMO, in writing, of its wish to terminate, and NIH will forward closeout instructions.
• If the grantee does not include a statement as to whether the change is or is not related to safe/healthful working conditions, OGM must go back to grantee and obtain this information.
• NIH Grants Policy Statement will be updated, accordingly.
NIH Summary Statement Available to the Signing Officials through the eRA Commons
• Notice Number: NOT-OD-20-126
• Release Date: June 18, 2020. Effective June 24, 2020
• Overall impact score and NIH Summary Statement will be made available in the eRA Commons to the Authorized Organization Representatives (AORs) of the applicant organization with the Signing Official (SO) user role in the eRACommons
• Program Directors/Principal Investigators will continue to receive notification of the availability of the summary statement and continue to access it in the eRA Commons
Pod Feedback Question
COVID-19-Related Carryover Requests
13
NIH COVID-19 Guidance for the Extramural Community
• NCATS is actively following NIH guidance related to administrative flexibilities provided to award recipients and applicants.
• NIH is continually releasing updated guidance on the NIH website -https://grants.nih.gov/policy/natural-disasters/corona-virus.htm. Check often, as previously released guidance has continued to be clarified
• Under the current guidance, non-SNAP award recipients are required to submit a Prior Approval request for review and approval in order to carryover unobligated balances on their active grants for immediate efforts to support activities related to or affected by COVID-19
NIH COVID-19 Guidance Regarding Carryover
• Guide Notice NOT-OD-20-086 released on March 12, 2020 provided guidance regarding flexibilities for
non-SNAP award recipients such that they:
“…have the discretion to carry forward unobligated balances on their active grants for immediate efforts
to support activities related to or affected by COVID-19”.
• The Guide Notice language was clarified in the Frequently Asked Questions posted on May 21, 2020.
“Yes, as outlined in NOT-OD-20-086, recipients of grants that do not fall under SNAP will be allowed to
carry forward unobligated balances on their active grants for immediate efforts to support activities
related to or affected by COVID-19. In order to track the use of this flexibility and ensure that approval is
noted prior to the submission and review of Federal Financial Reports (FFRs), recipients must contact the
funding IC for approval. NIH is providing maximum flexibility in the review of these requests. Reminder:
the charges must be allowable costs within the scope of the original award.”
• Please contact your assigned Grants Specialist and Program Official with questions
National COVID Cohort Collaborative
(N3C)
Update
Ken Gersing & Joni Rutter
National COVID Cohort Collaborative (N3C)
• Build a centralized national data resource—the NCATS N3C Data Enclave—for the research community to study COVID-19 and identify potential treatments as the pandemic continues to evolve
• Partnership among the CTSA Program hubs and the CD2H, with overall stewardship by NCATS
• Collaborators will contribute and use COVID-19 clinical data to answer critical research questions to address the pandemic
N3C Overview
Data
partnership &
governance
Phenotype &
Data
acquisition
Data ingest
&
harmonizati
on
Collaborative
analytics &
FAIR Sharing/Credit
HarmonizeIngest Collaborate(Analytics Platform)
OMO
P
Lim
ite
d D
ata
Se
ts
Limited/Safe
Harbor
Data Sets
Collaborative Analytics - Data Use
• COVID-Related research only
• Open platform to all Credentialed researchers
• Security: Activities in the N3C Enclave are recorded and can be audited
• Disclosure of research results to the N3C Enclave for the public good
• Analytics provenance
• Contributor Attribution tracking
• No download of data
Hub Data Status
Total DTAs Executed 43
Total IRB Approved(local and sIRB)
15
DTA Executed & IRB Approved(i.e., can begin data ingestion)
12
Total Sites Ingested 6
N3C Community Workstreams
NCATS N3C website: ncats.nih.gov/n3c
CD2H N3C website: covid.cd2h.org
Hub Partnership packet: https://covid.cd2h.org/partnership_welcome_packet
Onboarding to N3C: bit.ly/cd2h-onboarding-form
The All of Us Research Program:Applications for Population Research
Kelly Gebo, MD MPH
Chief Medical and Scientific Officer
June 24, 2020
23
⦿ Research funding: AHRQ, HRSA, NIAID, NIDA, Robert
Wood Johnson Foundation, Johns Hopkins CFAR
⦿ Scientific Consultant: Simon Fraser University
Disclosures
24
⦿ Present the mission, objectives, and scientific framework of the
All of Us Research Program
⦿ Demonstrate and explain how to explore the data currently being
collected within the AoURP
⦿ Explore the AoURP data browser and researcher workbench
Objectives
Framingham Heart Study
Kannel et al. Annals of Intern Med, 1961
Enrolled 5209 men and women in 1948
Some Framingham early discoveries:
• 1960 – Cigarettes increase heart
disease
• 1961 – cholesterol, blood pressure
increase heart disease
• 1967 – exercise decreases risk of
heart disease; obesity increases it
• 1970 – high blood pressure and atrial
fibrillation cause stroke
The impact of Framingham (and similar cohorts) has been dramatic
https://www.cdc.gov/Mmwr/preview/mmwrhtml/mm4830a1.htm
27
Mission & Objectives
To accelerate health research and medical breakthroughs,
enabling individualized prevention, treatment, and care for all of us
Nurture relationships
with one million or
more
participant partners,
from all walks of life,
for decades
Catalyze a
robust ecosystem
of researchers and
funders hungry to use
and support it
Deliver the largest,
richest biomedical
dataset ever,
making it as easy,
safe, and free to use
as possible
Contributes to the
All of Us team &
consortium
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⦿ Diversity at the scale of 1 million people or more
⦿ Focus on participants as partners
⦿ Longitudinal design, ability to recontact participants
⦿ Multiple data types: EHR, surveys, baseline physical
measurements, biospecimens, genomics, and more
⦿ National, open resource for all: broadly accessible to
all researchers with open source software & tools
⦿ Security and privacy safeguards for all participants
The All of Us Research Program: An Innovative Research Effort
29
⦿ Opened doors nationally on May 6, 2018
⦿ >248K participants have completed the full protocol, from
all 50 states
⦿ Built significant infrastructure to support the program:• 100+ academic, VA, FQHC, technology, & community partners
• 350+ clinics enrolling participants and still expanding
• Bilingual website, participant portal, app, and call center
• Biobank with 24-hour shipping process and capacity for 35M+ vials
• Interactive mobile exhibits that travel the country
Current Progress
30
Two Methods of Enrollment
HEALTH CARE PROVIDER
ORGANIZATIONSDIRECT VOLUNTEERS
Data Collection
32
Current Protocol
Enroll, Consent
and Authorize
EHR
Answering
Surveys
Physical
Measurements*
Provide
Biosamples*
Recruiting 18+
years old initially;
plan to include
children in future
Online, interactive
consent
Includes
authorization to
share EHR data
Initial surveys:
• The Basics
• Overall Health
• Lifestyle
• Health Care
Access &
Utilization
• Family Medical
History
• Personal Health
History
Blood pressure
Heart rate
Height
Weight
BMI
Hip circumference
Waist
circumference
Blood (or saliva, if
blood draw is
unsuccessful)
Urine specimen
Biosamples will be
stored at the
program’s biobank
*Based on diverse
sampling and capacity
*Based on diverse
sampling and capacity
Share data from
wearable fitness
devices, starting
with Fitbit
Coming soon:
Integrated apps to
track mood &
cardio-respiratory
fitness
Wearables and
Digital Apps
Additional surveys
will be released on
an ongoing basis.
⦿ Participants are asked to authorize linkage of their
EHR information.
Electronic Health Records
33
Initial Data Types Expanded Data Types (May Include)
• Demographics
• Visits
• Diagnoses
• Procedures
• Medications
• Laboratory
Visits
• Vital Signs
• Clinical Notes
• Radiology, cardiology, and other reports
• Mental Health Reports
• Substance Abuse, Alcohol use, and
Tobacco use
• More laboratory results, potentially
including genomics
34
Surveys at enrollment:
1. The Basics
2. Overall Health
3. Lifestyle
4. Health Care Access and Utilization
5. Family Medical History
6. Personal Health History
New:⦿ COVID Participant Evaluation
(COPE)
Many more in development:⦿ Diet⦿ Physical Activity⦿ Social Determinants of Health⦿ Mental Health and Wellbeing
Survey Modules
Physical Measurements
Participants will have access to their
physical measurements
⦿ Blood pressure
⦿ Heart rate
⦿ Height
⦿ Weight
⦿ BMI
⦿ Hip circumference
⦿ Waist circumference
35
36
⦿ Blood
DNA, plasma, serum, cfDNA, RNA
⦿ Saliva (DNA), if blood draw is
unsuccessful
⦿ Urine
⦿ Mayo Biobank: 24-hour shipping
with capacity for 35M+ vials
Biospecimen Collection
⦿ “Bring your own device”
(BYOD) program:
• Fitbit (now)
• Additional integrations in the
future
⦿ Pilots of specific smartphone-
based apps
• Mood app
• Others in development
Wearables and Digital Apps
37
38
⦿ Infrastructure
• Three Genome Centers: to generate genotyping & whole
genome sequencing for 1M participants by 2025
• Genetic Counseling Resource: to support return of
information to interested participants
⦿ Return of Information
Over time, the program anticipates providing several kinds of
information of interest to participants:
• Drug-gene interactions
• Genetic findings connected with risk of certain diseases
• Traits and ancestry
Genomics
39
Genetics Engagement Module (GEM) with Color
Ancestry Analysis
Simple Traits
Scientific Framework
All of Us Scientific Framework
41
Enable research that will:
• Increase wellness and resilience, and promote healthy living
• Reduce health disparities and improve health equity in populations that are
historically underrepresented in biomedical research (UBR)
• Develop improved risk assessment and prevention strategies to preempt
disease
• Provide earlier and more accurate diagnosis to decrease illness burden
• Improve health outcomes and reduce disease impact through improved
treatment and development of precision interventions
42
Example of research that will be enabled: Blood Pressure
BLOOD PRESSURE
What is the impact of economic
stability on rates of screening,
likelihood of receiving treatment, and
blood pressure levels?
Health Equity
How do age-related changes in
blood pressure in children and
young adults impact the
development of hypertension and
hypertension-related conditions in
adulthood?
Risk & Prevention
Diagnosis
Does ambulatory blood pressure
monitoring (ABPM) or home blood
pressure monitoring (HBPM)
provide a more accurate estimate
of cardiovascular risk?
What genomic, environmental, and
lifestyle factors underlie the
different patterns in age-related
trajectories of blood pressure,
thereby increasing or reducing the
risk of high blood pressure?
Wellness & Resilience
What are effective and scalable
community-based interventions
to improve blood pressure levels,
medication prescription and
medication fill rates?
Treatment & Outcomes
Research Hub
A platform to accelerate health research
Create a research platform that provides broad, secure access to All of Us data
and powerful tools to drive research results.
● Secure
● Modular
● Community-driven
● Open
● Standards-based
Discourages shared research Facilitates collaboration
Traditional approachBring data to researchers
Cloud-centric approachBring researchers to data
Tools
Tools
Tools
Tools
Tools
Tools
Tools
Tools
“Weakest link” security
Huge infrastructure needed
Pay for multiple copies
Bespoke & unsupported tools
Centralized security controls
Accessible to all researchers
Decreased cost of storage
Shared tool ecosystem
Discourages shared research Facilitates collaboration
Traditional approachBring data to researchers
Cloud-centric approachBring researchers to data
Tools
Tools
Tools
Tools
Tools
Tools
Tools
Tools
“Weakest link” security
Huge infrastructure needed
Pay for multiple copies
Bespoke & unsupported tools
Centralized security controls
Accessible to all researchers
Decreased cost of storage
Shared tool ecosystem
CDR Data Tiers Details
Summary of Identity Protection Rules
All of Us Data Tiers
Security
Ris
ks
High
Low
Publicly Accessible (no login needed)
Identity Verification
Research Ethics Training
Data Use Agreement
Public Summary Statistics
Registered tier Requirements plus
Institutional Sign-off
The All of Us Data Browser
48
49
⦿ Interactive tool launched on May 6, 2019
• Provides summary statistics from the program’s growing database
• Open to everyone – no login!
• Allows participants to understand the makeup of the cohort
• Allows researchers to understand the characteristics of our participant
population, explore the data types available, plan research questions
⦿ Visit: DataBrowser.ResearchAllofUs.org
All of Us Data Browser
The All of Us Data Browser – Data Snapshots
50
Current Progress
April 2018 Jan. 2019 Oct. 2019 April 2019 Oct. 2019 Jan. 2019 April 2020
Numbers are updated as of June 15, 2020
All 50 states
Bilingual enrollment
Interactive mobile exhibits
Geographic DistributionAge Distribution
Numbers are updated as of June 15, 2020
Numbers are updated as of June 15, 2020
Data Browser Overview
55
56
Search for specific keywords or browse using the different options underneath.
Search for specific keywords or browse using the different options underneath.
Available data gives insight into the
participant cohort & researchopportunities.
Mouse over charts & information icons for details & explanations.
Mouse over Bars & information icons for details & explanations.
Explore data breakdowns by Sex assigned at birth.
Explore data breakdowns by Sex assigned by age.
Mouse over Bars & information icons for details & explanations.
Mouse over charts & information icons for details & explanations.
Available data gives insight into the participant cohort & research opportunities.
Mouse over charts & information icons for details & explanations.
Overall Health PPI module Download the survey as a PDF
Registered and Controlled Tier Data
Dataset Builder >
Launched May 6, 2019 Launched May 27, 2020
Data Access and Research Hub Components
Data Passport Model
66
Data Release Timeline
All of Us is targeting a bold timeline. Projected dates are subject to
change and dependent on security and usability testing.
2019 2020 2021 & later
Dataset Expansion
Expansion of the All of Us dataset
with additional survey,
measurement, and EHR data.
Start of genotyping and whole
genome sequencing; initial return of
results to participants
Researcher Workbench
Beta Launch
May 27, 2020
Release of the first version of
the All of Us dataset and the
first set of researcher tools
for beta testing.
The dataset includes:
• Survey data
• Measurement data
• Electronic health record
(EHR) data
Additional Data Types and Tools
2021 & beyond
Expect to enroll 1M participants within
5-7 years of launch.
Continue to expand the All of Us
dataset with new data releases,
including over time:
• genomics data
• wearables data (such as Fitbit)
• new surveys
• assay data
• linkages to external data sources,
etc.
Release new versions of Researcher
Workbench with more tools.
Data Browser
Launch
May 6, 2019
Launch of an
interactive tool
available to the
public that
provides
summary
statistics from
the program’s
growing
database.
https://databrowser.researchallofus.org/
⦿ All of Us employs a “data passport” model for this access tier, to grant researchers
broad permission to explore the data for a wide range of studies
⦿ Beta testing access is available to researchers with eRA Commons accounts if
their institutions have signed a data use agreement. In the future, we’ll open the
platform more broadly
⦿ To facilitate collaboration and keep participant data secure, the Researcher
Workbench is hosted in a Cloud-based system
• All tools and data are in one place
• Data downloads onto your local machine are not allowed
• During the Beta testing phase, researchers will receive free credits to cover
computing and storage costs
67
Access and Security
Workspace
First, you will create a workspaces
where you will store all of the data and
analyses for a specific project
Your cohorts (participants), concept
sets (variables), cohort reviews,
datasets, and notebooks (where
analyses are run) for a project will live
in one shareable workspace
Tools to Build Cohorts and Datasets
All of Us Research Support
● User Support Hub○ Tool user guides
○ Instructional videos
○ Data model tutorials
○ Knowledge Base
○ Data Dictionary
■ PDF as part of detailed data documentation
■ Integrated directly within Workbench tools
● Researcher Workbench○ Featured Workspaces (example analyses, Phenotype Library)
○ Reusable “code snippets”
○ Demonstration Projects
○ Help Tips
● Help Desk Form○ Specialized forms
■ Ask a question or get help
■ Feedback
■ Publication
■ Billing credits
■ Privacy concerns
Looking into the future
AoU Data
6 surveys
Physical Measurements
Structured EHR data
Additional Digital
Health Tech
GIS and Census
Claims
Data Linkages
Bioassays from
stored samples
Additional
Surveys
Current Data
Additional Measurements
and Specimens Unstructured EHR Data
Notes, Labs,
Imaging…
-Omics
Robust Data Ecosystem
73
Shaping the future of All of Us
• What research is best suited to this large cohort?• Long term outcomes (rare will still be hard)
• Gene-Environment interaction
• Longitudinal research
• Diverse populations
• Comparative effectiveness research
• What data are crucial for your field of research?• Must-have data points: lab results, diagnostic codes, questionnaires
• Population characteristics
• Sample types and storage
• Frequency of data
74
Resource Sharing
• Data science tools developed in All of Us will be available to the
research community as they are tested and validated
• Access to the cohort will include ability to recontact participants
• Data linkages into the All of Us environment are planned for the
near future
• Merging data from other studies is a long-term goal
⦿ Not nationally representative
⦿ Data is not comprehensive
• will be continuing to expand in depth and breadth as time progresses
⦿ Not all participants will have all data types available
75
Limitations
⦿ Largest most diverse cohort assembled to date with plans for genomic data and
comprehensive clinical information
⦿ Successfully engaging participants as partners
⦿ New data types continuing to be rolled out
⦿ Sub-studies of specific populations or disease states possible
⦿ Will facilitate research across multiple disease states and could serve as
controls for disease-specific studies that lack healthy controls
76
Conclusions
All of Us Community and Provider Partner Network (as of January 2020)
78
All of Us Consortium Members (beyond community partners, as of March 2020)
The Participant Center
HPO Network
(Health Care Provider
Organizations)
RMCs
All of Us California
Illinois
Precision
Medicine
Consortium All of Us New EnglandTrans America
Consortium
New York City
Consortium
Participant Technology Systems
Center (PTSC)
University of Arizona and
Banner HealthAll of Us Pennsylvania
All of Us Southern NetworkAll of Us SouthEast
Enrollment Center
All of Us Wisconsin
FQHCs (Federally Qualified Health Centers) VA Medical Centers
Communications
& Engagement
Biobank Genomics
Partners
Data & Research
Center (DRC)
79
It takes All of Us….
ResearchAllofUs.org
80
For more information…
Precision Medicine Initiative, PMI, All of Us, the All of Us logo, and “The Future of Health Begins with You” are service marks of the U.S. Department of Health and Human Services.
@AllofUsResearch
#JoinAllofUsAllofUs.nih.gov
databrowser.researchallofus.org
Thank you!
Questions?
The University of Rochester Center for Leading Innovation and Collaboration (CLIC) is the coordinating center for the Clinical and Translational Science Awards (CTSA)
Program, funded by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH), Grant U24TR002260.
CLIC UpdatesMartin Zand
Deborah Ossip
I2I Webinar Schedule for the Careers in Translational Research Metric
Diversity & InclusionJuly 29th
2-3pm ET
University of Wisconsin
Duke University
Icahn School of Medicine – Mt.
Sinai
Recruiting Scholars/Trainees
Aug 27th
3-4pm ET
University of Massachusetts
University of Texas – San
Antonio
University of Michigan
Application & Screening Sept 29th
3-4pm ET
Johns Hopkins
Tufts University
University of Kentucky
Mentoring & Training Oct 20th
3-4pm ET
University of Alabama
Mayo Clinical Research
University of Indiana
Evaluation & Follow Up
Nov 10th
3-4pm ET
Johns Hopkins
University of Washington
Columbia University
A Call for Anti-Racism Resources
Resources will be shared on the CLIC Education & Career Gateway.
Email us at [email protected] OR upload directly to the
Education Clearinghouse on the CLIC website.97
Climate Surveys
Webinars & Talks
Empowering Tools & More!
Training & Curricula
COVID-19 Information
Onboarding to N3C: bit.ly/cd2h-onboarding-form
Joining Workstreams:N3C Data Ingestion & Harmonization Workstream
Slack Channel Harmonization
Google Group Harmonization
N3C Phenotype & Data Acquisition Workstream
Slack Channel Phenotype
Google Group Phenotype
N3C Collaborative Analytics Workstream
Slack Channel Analytics
Google Group Analytics
N3C Data Partnership & Governance Workstream
Slack Channel Governance
Google Group Governance
Additional Information: covid.cd2h.org
For the latest information about currently recruiting COVID-19 related
Clinical Trials, please visit the COVID-19 Clinical Trials feed curated list
from clinicaltrials.gov.
Please share your hubs’ events, news, educational content
around COVID-19 by posting them on the CLIC website using the
tag "COVID-19".
COVID-19 Collaborative Research Study Information Page: Any
hub can view/post information on research studies happening at
your hub
• Amplify research efforts
• Look for collaborations
• Reduce redundancy
Additional Information: https://clic-ctsa.org/covid-19
COVID-19
UPDATE –The 2020 Fall CTSA Program Meeting …
• Virtual Un-Meeting –½ day Zoom meeting
• Space will be limited – 1 “hub appointed attendee” will have guaranteed attendance
• COVID Rapid Response Synergy Paper RFA – Open September 14 - November 15
The previous August CLIC Un-Meeting date and topic have pivoted to
the following:What will clinical
research look like?
What do remote
trials look like?
What are the
impacts on
recruitment?What does
training look
like?
What alternative
interventions are
needed?
What is role of CTSA in
clinical research post-
COVID?
CLIC / NCATS Communication ChannelsSharing Content: CLIC Website
News (Consortium News & WOW! Factor
stories): clic-ctsa.org/news
Events: clic-ctsa.org/events
CLIC Funding opportunities (RFAs):
Synergy Papers; https://clic-
ctsa.org/collaboration/clic-synergy-papers
UnMeetings; https://clic-
ctsa.org/collaboration/clic-un-meetings
CLIC Education & Career Development
Gateway
Educational tools (Education
Clearinghouse): clic-ctsa.org/education
Career & training opportunities
(Opportunities Board): https://clic-
ctsa.org/opportunities-board
NCATS: twitter.com/ncats_nih_gov
CLIC: twitter.com/CLIC_CTSA
Hashtag: #CTSAProgram
CLIC Contact Us
Have a question and not sure where to direct
it?: clic-ctsa.org/contact
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Website: https://ctsa.ncats.nih.gov/cd2h/
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Recruitment Innovation Center (RIC)
Website:
https://trialinnovationnetwork.org/recruitment-
innovation-center
Subscribe to newsletter:
https://bit.ly/2OpEDHc
SMART IRB
Website: https://smartirb.org
Subscribe to newsletter: https://bit.ly/2JFbiK3
Trial Innovation Network (TIN)
Website: https://trialinnovationnetwork.org
Subscribe to newsletter:
https://bit.ly/2TXHQDZ
Reminders
• The next scheduled webinar will be Wednesday, July 22nd,
2:00 PM – 3:00 PM Eastern Time.
• Registration URL:
https://rochester.zoom.us/webinar/register/WN_Bz2g-
rQqTV6gJLI614aXgA
• https://clic-ctsa.org/groups/ctsa-program-group