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 RADxInfo@nih.gov

• 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

28

⦿ 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 education@clic-ctsa.org 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

Twitter

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

Newsletters

CTSA Ansible: Subscribe Here

CLIC News Roundup: Subscribe Here

NCATS e-Newsletter: ncats.nih.gov/enews

Mike’s Blog

https://clic-ctsa.org/news/mikes-blog

CTSA Program Initiative Channels

ACT Network

Website: http://www.actnetwork.us/National

Subscribe to newsletter:

https://bit.ly/2HQGsM5

IREx

Website: https://www.irbexchange.org

Subscribe to newsletter: https://bit.ly/2TtQG7b

National Center for Data to Health

(CD2H)

Website: https://ctsa.ncats.nih.gov/cd2h/

To Join: CD2H Onboarding

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

• ctsa_program_webinar@clic-ctsa.org

• https://clic-ctsa.org/groups/ctsa-program-group