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CTSA PROGRAM UPDATE
December 14, 2018
TABLE OF CONTENTS 

CTSA PROGRAM UPDATES
 
HELP US RENAME THE CTSA PROGRAM UPDATE!
CLIC and NCATS are working together to revamp and modernize the monthly CTSA Program Update. This includes a brand new title for the newsletter – and we want your help in naming it! We will be accepting submissions until December 31, 2018. The winning name, to be selected by Dr. Michael Kurilla, will be revealed in the new and improved January update on January 11, 2019.
 
Click here for more information and to submit your winning idea.
NIH HEALSM  PAIN EFFECTIVENESS RESEARCH NETWORK: CLINICAL TRIAL PLANNING AND IMPLEMENTATION COOPERATIVE AGREEMENT (UG3/UH3)
The purpose of RFA-NS-19-021 is to solicit cooperative agreement applications that propose clinical trials to establish the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate strategies or interventions to prevent and/or manage specific pain conditions, including medications, biologics, procedures, medical and assistive devices and technologies, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies, through well-controlled trials.
 
NCATS is interested in supporting research that establishes methods to translate efficacious non-opioid interventions for management of acute or chronic pain conditions into effective therapies that can be delivered successfully in rural settings.
 
Awardees will be required to conduct their studies through the NIH HEAL Pain Effectiveness Research Network (NIH HEAL Pain ERN), which will have dedicated pain and clinical trial design expertise.  The NIH HEAL Pain ERN will use the infrastructure of the NCATS Trial Innovation Network (TIN) to provide scientific guidance and coordination of the NIH HEAL Pain ERN trials. The TIN will work with the broad consortium of CTSA Program hubs and other sites identified by awardees to implement studies. The TIN investigators will work with UG3/UH3 awardees during the planning and implementation phases, and will provide clinical coordination center (CCC) services, data coordination center (DCC) services, recruitment and retention services, and biostatistical support.


See RFA-NS-19-021 for the complete funding opportunity announcement and visit the Trial Innovation Network website  for a list of CTSA Program hub resources.


For additional information please email Jane C. Atkinson, DDS at jatkinso@mail.nih.gov.

PRIOR APPROVAL OF NEW STUDIES WITH HUMAN SUBJECTS 
Prior Approval requests for new studies that involve human subjects research must be submitted to NCATS via the new eRA Human Subjects System beginning Jan. 1, 2019. For more details please refer to the email notification sent this week or contact your Program Official.
2019 SPRING CTSA PROGRAM GROUP MEETINGS
Additional details regarding meeting dates and times for the 2019 Spring CTSA Program Group Meetings, taking place March 4 and 5 in Washington, D.C., are now available on the CLIC website. 
CTSA PROGRAM WEBINARS
The next CTSA Program Webinar will take place on January 23. As a reminder, the December 26 Webinar has been cancelled. For more information, visit the CLIC site.
ADMINISTRATORS GROUP
The next CTSA Program Administrators quarterly webinar/call is scheduled for December 19 from 1:00 – 2:00 p.m. ET. These meetings are open to CTSA Program Hub administrators only. If you have not yet registered as one of the two hub administrators, please email administrators_group@clic-ctsa.org to be added. 

CLIC UPDATES
 
UF UN-MEETING ON RURAL HEALTH & HEALTH EQUITY 
The University of Florida (UF) Clinical and Translational Science Institute (CTSI), in collaboration with the UF Institute of Food and Agricultural Sciences (IFAS), has been selected as this year’s recipients of CLIC funds and support to host a national Un-Meeting. This event, taking place on April 8 in Gainesville, Florida, will focus on catalyzing new collaborations to bridge the translational science and agricultural extension sectors to improve rural health and health equity.

Look for more details in early 2019! In the meantime, read more here.
UPDATED CLIC WEBSITE
CLIC is excited to announce that we've made some changes and updates to our website. We encourage CTSA Program members to explore the site, share feedback and reach out with any questions.

COMMON METRICS UPDATES
 
COMMON METRICS SESSION: SPRING CTSA PROGRAM MEETING
A Common Metrics session will occur on Tuesday, March 5, 2019 from 8:30 a.m. – 12:00 p.m. as a part of the 2019 Spring CTSA Program Group Meetings. Hub Principal Investigators, Administrators and Evaluators are invited to attend. Session details will be forthcoming.
OPPORTUNITY TO EXCHANGE IDEAS
We have an online community established for Common Metrics on the CLIC Forum: Common Metrics. This is a place for you to ask questions, discuss best practices and/or strategies, and idea share. Log on to the website to participate in previous conversations or start new ones. You can view any of the current threads (thank you to those who have already contributed!). 
CM IMPLEMENTATION PROGRAM AND EVALUATION STUDY
The final report from the Tufts University CTSI on the Common Metrics Implementation Program and Evaluation Study is available here.
2016 COMMON METRICS HUB REPORT FEEDBACK RESULTS 
Subsequent to the release of the 2016 Common Metrics Hub Reports, the CLIC developed and sent a survey to each of the hubs. The survey was designed to solicit feedback regarding the usefulness of each of the report sections and to obtain suggestions for improving future reports. A summary report of the survey results is now available on the CLIC website.
INFORMATICS COMMON METRIC UPDATE
Phase 2 of the Informatics Metric implementation will begin in January 2019. For implementation and reporting information click here. All hubs are expected to participate in this phase. Metric operational guidelines (OG), Informatics Common Metrics team formation tool, and an overview of informatics are all available on our Common Metrics webpage.

Please do not hesitate to contact us if you have questions regarding your Informatics Metric implementation – common_metrics@clic-ctsa.org.

DOMAIN TASK FORCE (DTF) UPDATES
 
DTF Workgroup Guidance

CTSA Program Leadership has provided clarification regarding DTF activities while the Steering Committee DTF Task Force continues to consider modifications to the current DTF system:
  1. DTF Elections may take place.
  2. Work Groups
    1. Existing: Continue; you are encouraged to scale remaining activities/objectives for completion by Dec. 2019.
    2. New
      1. Three new iDTF Work Groups were presented at the Fall Steering Committee meeting and have completed charters. These three may proceed with the understanding that the activities/objective(s) will be scaled for completion by Dec. 2019.
      2. Other DTFs considering new Work Groups
        1. DTFs are encouraged to focus on one or two new, targeted areas over the next 12 months.
        2. New Work Groups may be proposed to the Steering Committee; request must include:
          • Specific Objective/Challenge to be addressed
          • Broader context/goal
          • Timeline w/ Milestones (completion by Dec. 2019)
          • Output/Deliverable
COLLABORATION & ENGAGEMENT DTF 
The Collaboration & Engagement DTF Lead Team election has been completed – three new members have been voted to the Lead Team. Linda Ko is the co-director of the community engagement program at the Institute of Translational Health Sciences at the University of Washington, Elizabeth Miller is the co-director for community engagement for University of Pittsburgh Clinical and Translational Science Institute, and Laurene Tumiel-Berhalter is the community engagement core director for the University at Buffalo’s Clinical and Translational Science Institute. We welcome them to the Lead Team!

Save the Date! The Collaboration & Engagement DTF Face-to-Face Meeting will be held on Tuesday, March 5, 2019 in Washington D.C. Additional details will be shared as they become available.
INFORMATICS DTF
Save the Date! The Informatics DTF (iDTF) Face-to-Face Meeting will take place on Friday March 29, 2019 in San Francisco from 7 a.m. – 1 p.m. PT. Let us know what else you’d like to discuss via the REDCap survey sent out on Monday, November 5 or email via informatics_dtf@clic-ctsa.org
 
New Work Groups
 
Three new iDTF Work Group charters have been approved by the CTSA Program Steering Committee effective December 5, 2018. 
  • Enterprise Data Warehouse
  • Sustainability Phase Two
  • Text Analytics and De-Identification
The Work Group leads are working to determine meeting days and times to get started in January. Stay tuned! Interested in joining? Contact informatics_dtf@clic-ctsa.org and your request will be sent to the appropriate leads.
 
Publishing Update
 
We are very pleased to announce that the Sustainability Informatics Infrastructure Work Group has successfully published their paper from phase one of the Sustainability Work Group: Sustainability Considerations for Clinical and Translational Research Informatics Infrastructure (can also be accessed on the CLIC website via the iDTF page).  
 

Authors:
Obeid, J., Tarczy-Hornoch, P., Harris, P., Barnett, W., Anderson, N., Embi, P., . . . Wehbe, F. (n.d.). Sustainability considerations for clinical and translational research informatics infrastructure. Journal of Clinical and Translational Science, 1-9. doi:10.1017/cts.2018.332

UPDATES FROM OTHER CTSA PROGRAM INITIATIVES
 
ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK
The ACT Network recently hosted its End of Year webinar that covered overall goals and dissemination plans for 2019 in addition to i2b2, SHRINE, and ontology development goals. Reach out to Elaina Sendro for a link to the recording. In the first quarter of next year, we look forward to hosting our first dissemination fireside chat. The selected topic based on input from our ACT community is “Integrating ACT into CTSA Hub Services.”
 
To stay up to date on logistics for this fireside chat and other plans for next year, register for the ACT monthly newsletter here. We encourage you to also visit our national website to learn more about ACT.
 
Questions?  Contact Elaina Sendro

NATIONAL CENTER FOR DATA TO HEALTH (CD2H)
Call for Proposals: CD2H $100K Idea Competition
 
CD2H is excited to announce the launch of the CD2H Idea Competition. This is an opportunity to turn your scientific question into a DREAM Challenge to be tackled by teams around the world. If your idea is selected, you will receive up to a $100K subcontract to run the DREAM Challenge in collaboration with the CD2H. Proposals can be submitted by any researcher, clinician, or staff member affiliated with an institution that has a CTSA Program hub (with the exception of sites that already receive subcontracts from CD2H).
 
Deadline for initial Idea Competition proposals: February 15, 2019. To learn more and submit a proposal please visit: http://bit.ly/CD2H_idea.
New Opportunities from the CD2H
 
The newest newsletter from the CD2H offers valuable information on new resources and opportunities for the CTSA Program community including details on a new tool to help hubs launch co-learning initiatives and an upcoming interactive CD2H Show and Tell webinar about upcoming DREAM Challenge opportunities for hubs. Read the details, and also check out the new two-page overview of the CD2H in the newsletter here: .
 
Stay Current
 
Subscribe to the CD2H Newsletter and be sure to follow on Twitter at @data2health.

TRIAL INNOVATION NETWORK (TIN)
TIN would like to share new resources that are now available in the Recruitment and Retention Toolbox:
  • Person Centeredness of Research Scale and Scoring
    • The PCoR Scale is the first validated quantitative scale to assess person-centeredness of research products. This 7-item scale allows an objective and structured assessment of the extent to which research reflects the needs, priorities and values of patients, families, individuals and communities that are the focus of the research. This instrument will help funding organizations, policy makers, researchers, patients, community organizations and other stakeholders objectively assess research products and will inform the healthcare community on the extent of person-centered approaches in research and the evolution of those methods over time.
  • Recruitment Innovation Center (RIC) Templates for Sharing Study Results
    • Includes:
      • Community Policy Brief PCHP Template
      • Comparing Methods to Make Research Person Centered
      • Example: Sharing Research with Community
      • Community Summary Template
See these resources and more here.

Upcoming Webinars
  • The Trial Resource Pack: Best Practices and Tools for Recruitment and Retention
    • December 19, 2018, 12:00 p.m. ET
    • Register
Questions?  Contact Terri Edwards

RECRUITMENT INNOVATION CENTER (RIC)
Moving into the New Year, RIC would like to thank the 58 CTSA Program institutions and their study teams that have participated in the TIN Consultation process. We have enjoyed learning more about your projects and appreciate your willingness to collaborate on innovations related to the recruitment and retention of participants in clinical trials. We look forward to sharing new innovations that will be rolling out in the first quarter of 2019. Our goal continues to be to work with researchers to develop, test and share innovations to improve participant recruitment and retention and in doing so, improve health outcomes. We aim to raise national awareness of the importance of clinical trials and opportunities for the public to be involved.
 
Questions?  Contact Mary Stroud
SMART IRB
500 and Counting! 

SMART IRB’s reliance network recently surpassed 500 institutions. Our members include Clinical and Translational Science Award hubs and affiliates, universities, academic medical centers, community hospitals, cancer centers, disease foundations and patient-powered research networks, independent IRBs, and others. Take a moment to explore the full list of SMART IRB Participating Institutions.
Resource Library: New Look, Same Great Taste.

We've given our resources a little redesign – so, don't fret if things look a little different. Our guidance, checklists, SOPs, FAQs, etc., are all steady on, and we'll let you know if anything changes. Find what you need in the Resource Library.

We’re here to help.

Questions about using the SMART IRB Agreement and resources at your institutions? Not sure how to help study teams navigate single IRB review? Connect with a SMART IRB Ambassador or contact us.

ANNOUNCEMENTS & OPPORTUNITIES
 
A full list of NCATS announcements and opportunities can be found here: https://ncats.nih.gov/funding/open.
NOTICE OF INTENT TO PUBLISH AN FOA FOR PRAGMATIC AND IMPLEMENTATION STUDIES FOR THE MANAGEMENT OF PAIN TO REDUCE OPIOID PRESCRIBING (PRISM) (UG3/UH3, CLINICAL TRIALS OPTIONAL)

The National Center for Complementary and Integrative Health (NCCIH), along with partnering Institutes/Centers/Offices intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
 
The FOA is expected to be published in Fall 2018 with an expected application due date in Winter 2019. This FOA will utilize the UG3/UH3 activity code. Details of the planned FOA are provided here: NOT-AT-19-004.

TRAINING INSTITUTE FOR DISSEMINATION AND IMPLEMENTATION RESEARCH IN CANCER (TIDIRC) 2019 NOW ACCEPTING APPLICATIONS

Applications are due by noon on January 16, 2019. Applicants will be notified of their acceptance status by February 8, 2019. For questions concerning the training or application process, please review the FAQ page or contact the Implementation Science Team at NCIdccpsISteam@mail.nih.gov. To submit your application please follow this link: https://cancercontrol.cancer.gov/IS/training-education/tidirc/application.aspx.

REISSUES OF THE CTSA PROGRAM COLLABORATIVE INNOVATION AWARD (CCIA) FUNDING OPPORTUNITY ANNOUNCEMENTS

MEETINGS & EVENTS
 

UPCOMING CONSORTIUM EVENTS 

CTSA Program hubs can find information about meetings, events, conferences, and/or items relevant to the CTSA Program and the advancement of translational science on the events page on the CLIC website. If you would like to showcase an event, please fill out the event form (login required).
 
Once you host an event, if you would like your presentations uploaded for viewing on the archived CLIC events page, please submit a PDF version of your event presentations to the email below.
 
Questions?  Contact help@clic-ctsa.org

UPCOMING NCATS MEETINGS 

Date Event More Information
Second Monday of the month;
2:30 – 4 PM ET
CTSA Program Steering Committee Meeting Executive Session CLIC Steering Committee Meetings Page*
Fourth Wednesday of the month;
2 – 3 PM ET
CTSA Program Webinar Webinar Registration**

Please note that the December 26 CTSA Program Webinar has been cancelled.

*CLIC will post meeting summaries from the Steering Committee calls onto the CLIC website and continue to circulate monthly CTSA Program newsletters with important project-level updates and consortium activities.
 
**To add the CTSA Program Webinar to your calendar: Please make sure that once you submit the completed registration form, choose “add to calendar” on the Registration Approval page OR in the Confirmation email that you receive, then open and save the downloaded calendar file.
 
You can find this or any of the past CTSA Program Updates on the CLIC Newsletters page or on the CTSA Program Communications page.

Copyright © 2018 CLIC, All rights reserved.

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