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CTSA Program Webinar Wednesday, August 28, 2019 2:00 PM 3:00 PM ET

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Page 1: CTSA Program PI Webinarnode:type]/field_meeting_presentations/CTSA Program...25 unique institutions 4 U01; 2 R21 awards 20 unique institutions 7 U01; 0 R21 awards 24 unique institutions

CTSA Program Webinar

Wednesday, August 28, 2019

2:00 PM – 3:00 PM ET

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Agenda

2

Time Topic Presenter

2:00 PM -

2:05 PM

Welcome

NCATS and CTSA Program UpdatesClare Schmitt, PhD

2:05 PM -

2:25 PM

Informatics Common Metrics

Implementation and Data Report

Ken Gersing, MD

Ann Schwartz, MPH

2:25 PM -

2:45 PM

CTSA Program Collaborative Innovation

Awards (CCIA)H. Timothy Hsiao, PhD

2:45 PM –

3:00 PMCLIC Updates Deborah J. Ossip, PhD

3:00 PM Adjourn

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NCATS and CTSA Program Updates

Clare Schmitt

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Transition to Enterprise Committees

• Transition is in full swing

• Domain Task Force Summary Report

• SC reviewed

• 3 requests for WG extensions of 6-12 months

• Informatics: 2; Methods & Processes: 1

• SC decision: all 3 should submit a request for a new WG and/or transition

to a Discussion Forum in Jan 2020

• WG Application: Submissions Oct. 1-31 (revised dates)

4

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CTSA Program Competitive Revision (Supplement) Solicitation

• PAR-19-337

• Eligibility: Awardees with active CTSA Program hub awards (UL1). Only

applications for revisions to the UL1 award are allowed. Revisions to the

linked KL2 and/or the TL1 awards are not allowed.

• Purpose: Support the demonstration, dissemination, and/or

implementation of highly innovative and impactful translational science

projects that address the goals of the CTSA Program and are beyond the

original scope of the approved parent project

• Earliest Submission Date: August 25, 2019

• Due Dates: September 25, 2019; September 25, 2020; September 27, 2021

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CTSA Program Feedback

Soliciting input on process (RFA issues) and program objectives

• Peer Reviewers

• Public & Consortium members• Request for Information (RFI; mid-Sept thru late Oct 2019)

• Town Hall Q&A January 2020 (tentative)

• NCATS

6

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Informatics CM Implementation and Data ReportKen Gersing

Ann Schwartz

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Informatics Common Metrics Implementation and Data ReportThe complete report is available on the Hub Report page of the CLIC website – log in is required

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Informatics Vision the CTSA Program

Vision:

The CTSA Program is a collaborative and interoperable national research network

that will leverage resources across multiple systems and unique expertise within our

institutions to connect research to health care that results in better health through

research

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Goals for the Informatics Common Metric

• Meaningful and useful activity for both local hubs and CTSA Program

• Low cost/burden of implementation – Scripts are prebuilt for community

• Align with other CTSA Program initiatives i.e. TIN, ACT, CD2H

• Facilitate the interoperability of research data through the use of standard value

sets i.e. ONC, HL7, CDISC, NCI EVS, NLM etc.

• Facilitate sharing of research data across common data models i.e. PCORI,

ACT/i2b2, Sentinel, and OMOP (FAIR Data Principles)

• Facilitate Translational Science across the research spectrum, preclinic to clinical

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Goals for Informatics Implementation• Establish a set of baseline characteristics at each CTSA’s Research

Data Warehouse (RDW)

• Encourage hubs to record data using standard value/code sets• ICD, RxNorm, LOINC, etc.

• Standardize Research Data Warehouses (RDWs) to increase interoperability for investigators across the consortium

Over time, this metric will evolve into a comprehensive characterization of RDWs, as well as a quality improvement tool

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Results

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136,333,783 Unique Patients in 58 Hubs

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Patient Count by Data Domain

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Data Domain and Data Model by Hub

NMR = No Model ReportedOther = Not OMOP, PCORnet, i2b2/Act, TriNetX or reported multiple data models

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Observations Present by Data Model

i2b2/ACT

26%

OMOP

15%

PCORNet

14%

TriNetX

7%

Other

21%

NMR

10%

Missing

7%

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“Other” and “NMR”

• Scorecard functionality did not enable hubs to use a drop-down menu for data model

• Multiple data models were entered

• Data source rather than data model was entered

• Name variations in data models

See Appendix 8 for details regarding data

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Variations in Data Reporting

• Data entry

• Scorecard functionality

• Hub data/data model• Request for Approval for Alternate Informatics Data Model

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Next Steps

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Informatics Common Metric: Year 2

• This metric was designed to evolve over time to enhance the completeness of the data repositories across the CTSA Program consortium and incorporate additional types of data with repositories as the CTSA Program, in collaboration with the iDTF, finds useful and appropriate.

• Hubs were encouraged to test the collection of additional data domains to inform the iDTF discussions about the evolution of the metric (and send info to CLIC https://clic-ctsa.org/common_metrics/help-desk)

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Informatics Common Metric: Year 2

• Step 1: CLIC/NCATS review feedback from Year 1 and consult with iDTF members:

• Potential additional data domains:

• Vitals (height, weight, temperature, respiratory rate, pulse, diastolic and systolic)

• Visits with procedures (% of visits with procedure code)

• Others?

• Incorporate a timeframe for data capture

• 1 year and 5 year

• Step 2: Work with “Quality Improvement Committee”:• To add to the scripts and test the scripts:

• Data model experts

• Script developers

• Testers of the new scripts

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Timeline: Year 2

• Fall 2019:• Review new enhancements and consult with iDTF

• Quality Improvement Committee to modify scripts and test

• Present and get feedback to enhancements:

• CTSA Program Common Metrics Initiative Executive Committee

• CTSA Program Steering Committee (get feedback, test any updates on scripts)

• Winter/Spring 2020• Release enhanced scripts and Operational Guidelines

• Common Metrics Reporting for 2019 data:• Due August 31, 2020

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Q&A

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CTSA Program Collaborative Innovation Awards (CCIA)H. Timothy Hsiao

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25

Goal of this Presentation

• To provide updates and review of the CCIA portfolio

• To promote collaborations through the CCIA mechanisms to accomplish the CTSA Program goals

Expected Outcomes• New collaborations

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The CTSA Program Collaborative Innovation Award (CCIA):

Updates & Portfolio Review

H. Timothy Hsiao

August 28, 2019

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CCIA Program Structure

U01

≥3 CTSA Program hubs;

or, ≥2 CTSA Programs hubs + ≥1 IDeA-CTR

PAR-19-099;

NOT-TR-19-016

R21 (Exploratory)

≥2 CTSA Program hubs

PAR-19-100

Mechanism FOA

Objective

Foster research collaboration to develop, demonstrate and/or

disseminate innovative, experimental approaches to overcoming

translational science roadblocks.

Eligibility

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Useful Definitions

CTSA Program Hub:

A UL1 award with a linked KL2 award and an optional TL1 award. A hub that is in no-

cost extension (NCE) status is not considered a currently funded CTSA Program hub

(see https://ncats.nih.gov/ctsa/about/hubs).

CTSA Program Hub Institution:

Includes the recipients of the CTSA Program hub award, as well as any institutions

listed as partners in the CTSA Program hub UL1 awards.

IDeA-CTR Participating Institution:

The lead institution of an IDeA-CTR award or any of the partner institutions of the

IDeA-CTR award.

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CCIA (R21 - Exploratory) (PAR-19-100)

Next Receipt Date:

November 8, 2019

Eligibility:

An application must involve investigators who are supported by CTSA Program

hub institutions from at least two different and currently funded CTSA Program

hubs as of the due date of the application.

Hubs in a no-cost extension do not meet the eligibility criteria.

The contact PD/PI must be employed by and/or a recipient of funding from a

currently funded CTSA Program hub institution as defined above in Eligible

Organizations.

Project Period and Budget:

The maximum project period is 2 years.

The combined budget for direct costs for the two-year project period may not

exceed $275,000. No more than $200,000 may be requested in any single year.

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CCIA (U01) (PAR-19-099) (NOT-TR-19-016)

Next Receipt Date:

November 8, 2019

Eligible Organizations:

An application must involve investigators who are supported by CTSA Program hub

institutions from at least three different and currently funded CTSA Program hubs as

of the due date of the application or alternatively, an application may involve

investigators from at least two different and currently funded CTSA Program hubs (of

which one must be the contact PI on the application) and one or more currently

funded NIH Institutional Development Award (IDeA) Program Infrastructure for

Clinical and Translational Research (IDeA-CTR) participating institution, as of the

due date of the application. (*Note: This eligibility criterion applies to the IDeA-CTR

awards only, not broadly to the entire IDeA programs such as INBRE and COBRE.)

CTSA Program Hubs or IDeA-CTR participating institutions that are in no-cost

extension (NCE) status do not meet the eligibility criteria.

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Eligible Individuals:

The contact PD/PI must be employed by and/or a recipient of funding from a

currently funded CTSA Program hub institution as defined above in Eligible

Organizations. (*Note: As an example, an IDeA-CTR PI will not serve as the one to

submit the CCIA application.)

Investigators who are not employed by and/or a recipient of funding from a CTSA

Program hub institution (such as investigators whom are employed by an IDeA-CTR

participating institution), but who wish to bring an innovative project to the CTSA

Program, can co-direct a project using the multiple PD/PI option in partnership with a

contact PD/PI who holds employment or funding from a currently funded CTSA

Program hub institution.

CCIA (U01) (PAR-19-099) (NOT-TR-19-016)

Project Period and Budget:

The maximum project period is 4 years.

No more than $750,000 or $400,000 (depending on whether clinical research

is involved) direct costs annual budget should be requested.

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NCATS is prohibited from direct funding of any 21 CFR-defined Phase III clinical trialunless the target is a rare disease or condition, and must follow certain steps prior to funding (including public notice for ≥120 days)

Applicants and awardees are encouraged to discuss with the PAR-19-099 Scientific Contact regarding any potential for 21 CFR-defined Phase III clinical trial, including changes to planned Phase II clinical trial

*Phase III Clinical Trials (NOT-TR-18-025)

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35

CCIA Portfolio Review

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36

7

4

76

7

11

18

24

0

5

10

15

20

25

FY16 FY17 FY18 FY19

Nu

mb

er

of

Pro

jec

tsCCIA (U01) Portfolio Growth

New Award

Cumulative

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37

Collaborating Institutions

FY18

Max= 8

Min= 3

Max= 6

Min= 4

Mean= 5.7

Mean= 4

Mode= 5

Mode= 3

U01 R21

7 U01; 5 R21 awards

38 unique institutions

FY19

(not final)FY16 FY17

Max= 6

Max= 4

Min= 3

Min= 2

6 U01; 2 R21 awards

1 pending R21 award

25 unique institutions

4 U01; 2 R21 awards

20 unique institutions

7 U01; 0 R21 awards

24 unique institutions

Max=9

Min=3 Min=2

Max=2

Min=4

Max=5

*Note: Counts are approximate only due to the various affiliations among organizations and individuals.

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CCIA (FY16): U01 (N=7)

38

• Strengthening Translational Research in Diverse Enrollment (STRIDE) (U01TR001812-01) (UMass)

Engage patients and communities in every phase of the translational process

• Disseminating Curative Biological Therapies for Rare Pediatric Diseases (U01TR001814-01) (Boston Children’s)

• Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns (U01TR001792-01) (RTI)

Promote integration of special and underserved populations in translational research across the human lifespan

• A National IPS Cell Network with Deep Phenotyping for Translational Research (U01TR001810-01) (BU)

• Leveraging Existing Registry Resources to Facilitate Clinical Trials (U01TR001803-01) (Duke)

Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials

• Improving Patient-Reported Outcome Data for Research Through Seamless Integration of the PROMIS Toolkit into EHR Workflows (U01TR001806-01) (Northwestern)

• Transformative Computational Infrastructures for Cell-Based Biomarker Diagnostics (U01TR001801-01) (J. Craig Venter Institute, Inc.)

Advance the use of cutting-edge informatics

Addressing CTSA Program Goals:

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CCIA (FY17): U01 (N=4); R21 (N=2)

39

• Development, Implementation and Assessment of Novel Training in Domain-Based Competencies (DIAMOND) (U01TR002013-01) (Michigan)

Train and Cultivate the Translational Science Workforce

• Translating Research into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care (U01TR002070-01) (Boston Medical Center) (*co-funded by NIH Office of Behavioral and Social Sciences Research)

Promote integration of special and underserved populations in translational research across the human lifespan

• Investigating Teleconsent to Improve Clinical Research Access in Remote Communities (R21TR002088-01) (MUSC)

• Measure Development to Accelerate the Translation of Evidence-Based Clinical Guidelines into Practice (U01TR002008-01) (NYU)

• Modulation of Gut-Brain Axis Using Fecal Microbiome Transplant Capsules in Cirrhosis (R21TR002024-01) (VCU)

Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials

• Open Health Natural Language Processing Collaboratory (U01TR002062-01) (Mayo)

Advance the use of cutting-edge informatics

Rural Health-related (N=1)Addressing CTSA Program Goals:

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CCIA (FY18): U01 (N=7); R21 (N=5)

40

• TEAMSS – Transforming Expanded Access to Maximize Support & Study (U01TR002488-01) (Michigan)

• Peer-based Retention of people who Use Drugs in Rural Research (PROUD-R2) (U01TR002631-01) (OHSU)

Engage patients and communities in every phase of the translational process

• Impact of Breast Milk on Infant Gut Microbiome (R21TR002516-01) (Rochester)

• Precision Medicine in the Diagnosis of Genetic Disorders in Neonates (U01TR002271-01) (Tufts)

• Transforming Exercise Testing and Physical Activity Assessment in Children: New Approaches to Advance Clinical Translational Research in Child Health (U01TR002004-01A1) (UC Irvine)

• Accelerate cellular immunotherapy development for treatment of life-threatening childhood disorders (U01TR002487-01) (Seattle Children’s)

Promote the integration of special and underserved populations in translational research across the human lifespan

• A platform trial design to accelerate translational therapies in a canine disease model of ALS (R21TR002277-01A1) (UMissouri Columbia)

• Increasing Access to Clinical Microbiome Specimens via a Living µbiome Bank (R21TR002513-01) (MUSC)

• Effects of ApoE-enhancing Compounds on Alzheimer’s Disease Phenotypes In Vivo (R21TR002029-01A1) (Columbia)

• TCR and BCR deep sequencing to distinguish autoimmune recurrence from allograft rejection (R21TR002279-01) (Columbia)

• Harnessing human brain and liver microphysiological systems for testing therapeutics for metastatic melanoma (U01TR002383-01) (Vanderbilt)

Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials

• Harnessing the power of CTSA-CDRN data networks: Using social determinants of health, frailty and functional status to identify at-risk patients and improve risk adjustment (U01TR002393-01) (UTHSCSA)

Advance the use of cutting-edge informatics

Addressing CTSA Program goals: Opioid-related (N=1); Rural Health-related (N=1)

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CCIA (FY19 – Not Final): U01 (N=6); R21 (N=2 + 1 Pending)

41

• Translational Research Workforce Training: Leveraging the Veterinary Specialist (U01TR002953-01) (Wisconsin)

Train and Cultivate the Translational Science Workforce

• Genetic and Functional Dissection of Congenital Anomalies of the Brain (R21TR002770-01) (UNC)

Promote the integration of special and underserved populations in translational research across the human lifespan

• Coordinated medical treatment of opioid use disorder and infectious disease (U01TR002763-01) (Yale)

• SPROUT-CTSA Collaborative Telehealth Research Network (U01TR002626-01) (MUSC)

• ICT Tools for Rare Diseases (R21TR002402-01A1) (RTI)

Innovate processes to increase the quality and efficiency of translational research, particularly of multisite trials

• Unintended Prolonged Opioid Use (U01TR002743-01) (Mayo)

• Instrumenting the Delivery System for a Genomics Research Information Commons (U01TR002623-01A1) (Boston Children’s)

• Enhancing Infrastructure for Clinical and Translational Research to Address the Opioid Epidemic (U01TR002628-01A1) (MUSC)

Advance the use of cutting-edge informatics

Addressing CTSA Program Goals) Opioid-related (N=3); Rural Health-related (N=1)

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CCIA Project Highlight (FY16)

Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic

Clinical Trials in Newborns (U01TR001792-01) (RTI)

Objective:

Establish a voluntary newborn screening research program to study the benefits of

screening for rare disorders so that policy makers will have the evidence they need to

make good decisions about newborn screening policy

Progress:

Program launched in Oct 2018 - https://earlycheck.org//

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Objective:

Test strategies to improve retention of people who use drugs in research in rural communities and fosters facilitation of rural participants into clinical trials

Features:

Using rural peer retention specialists: an extension of the “peer navigator” model for study retention

Leveraging Oregon and Appalachian Kentucky and Ohio infrastructure, part of the National Rural Opioids Initiative, a multi-state consortium studying access to care, overdose, and infectious consequences of opioid use disorder in rural America

4343

CCIA Project Highlight (FY18)

Peer-based Retention of people who Use Drugs in Rural Research

(PROUDR2) (1-U01TRTR002631-01) (OHSU)

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44

Program Contact:

H. Timothy Hsiao, Ph.D.

Program Director, Division of Clinical Innovation

National Center for Advancing Translational Sciences

Office: 301.594.8928 | e-mail: [email protected]

More Information about the CCIA Program:

Landing Page

FAQ

PAR-19-099

PAR-19-100

[email protected]

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CLIC UpdatesDeborah J. Ossip, PhD

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.

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Request for Applications

Un-Meetings

• Apply to host an attendee-driven event without

traditional rules and structure

• One hub will receive funds, planning guidance and

materials, and high-level coordination from CLIC

Application deadline: September 11, 2019

• Learn more: https://clic-ctsa.org/collaboration/clic-un-meetings

• Contact: [email protected]

Synergy Papers

• Apply to collaborate on a manuscript that showcases

a new or transformed assessment or perspective

relative to translational science

• Receive funds and administrative support from CLIC

Application deadline: October 2, 2019

• Learn more: https://clic-ctsa.org/collaboration/clic-synergy-papers

• Contact: [email protected]

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CTSA Program Meeting

REGISTRATION DEADLINE EXTENDED• On-Site – September 9th

• ZOOM – September 20th

• Register Here:

• https://clic-ctsa.org/events/2019-fall-ctsa-program-meeting• You will need to be logged into your CLIC account to register (if you do not

have a log-in, you can sign up on the CLIC website)

• Just a few benefits to this change:

• Auto-filling your registration form with information from your account

• Confirm or edit your registration details directly from your account page

• Resend the confirmation letter for your records

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CTSA Hub Poster Session

• The 2019 Fall CTSA Program Meeting will kick off with a Hub Poster Session.

• Thursday, September 26th from 6:00 PM to 8:00 PM ET

• Theme: CTSA Program Optional Cores

• 1 poster per hub

• Electronic versions of the posters will be available

• You will need to log into the website before you click “to submit a poster”

• SUBMISSION EXTENSION!!• New Deadline to Reserve Spot– September 9th

• Complete the abstract to reserve your hub’s spot

• The posters do not have to be finalized to reserve your spot

• New Deadline for Final Details – September 16th

• Upload final poster by COB September 16th

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CLIC Website Updated!!

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CLIC Website Upgrade• To create changes based on user interaction, user analytics and

suggestion box comments

• To prepare for the new group structure

CLIC Homepage Interaction Heatmap

75% of users

50% of users

25% of users

New Group Structure

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New Homepage

Consortium submitted content higher on the page• Use of colored labels to show content type

Maintained rotating banner for high visibility news

Login - Here

Expanded menu bar

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Group Pages – New Look

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Improved Account Page

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Share Content

Once logged in click

on “Share Content” at

the top of any page to

access the

submission forms

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Contact CLIC

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DTF to EC Transition Updates

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Application ProcessMany questions are similar to what was

included previously in Working Group

Charters:

• Purpose

• Goals

• Deliverables

• Timelines

A few new questions:

• How does this WG differ from or

complement current efforts?

• If sponsored by an EC, you will need to

upload a letter of support from the lead

team

• Expected impact

• Expertise needed to accomplish goals

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Application Process

NEW

• You will have a chance

to select from this list of

additional support/resources

from CLIC, CD2H and TIN.

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Revised Submission Timeline For Round 1

System

Live

Proposals

Due

SC Review Earliest

WG Start

Oct 1 Oct 31 Nov 15-

Dec 8

Jan 1

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CLIC/NCATS Communication ChannelsSharing Content: CLIC Website

News (Consortium News & WOW! Factor stories):

clic-ctsa.org/news

Events: clic-ctsa.org/events

Educational tools (Education Clearinghouse): clic-

ctsa.org/education

Funding opportunities (RFAs):

https://clic-ctsa.org/collaboration/clic-synergy-

papers

https://clic-ctsa.org/collaboration/clic-un-

meetings

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

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

Subscribe to newsletter:

https://bit.ly/2HQGsM5

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

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Questions?

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Reminders

• September’s CTSA Program Webinar is CANCELLED.

• The next scheduled webinar will be Wednesday, October 23rd,

2:00 PM – 3:00 PM Eastern Time

[email protected]

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