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CTSA PROGRAM UPDATE
September 14, 2018
TABLE OF CONTENTS 
  • CTSA Program Updates
  • CLIC Updates
  • Common Metrics Updates
  • Domain Task Force Updates
  • Updates from other CTSA Program Initiatives
  • Announcements & Opportunities
  • Meetings & Events
CTSA PROGRAM UPDATES
 
REGISTRATION NOW OPEN – FALL CTSA PROGRAM MEETING
Registration for the 2018 Fall CTSA Program Meeting, taking place October 22-23 at the Hilton Crystal City in Arlington, is now available! Please note: the Full Day Fall CTSA Program Meeting is October 23 only. Further details and a tentative agenda are available on the CLIC website. If you have questions or need further information, please contact the CLIC Meeting Planner, at program_meetings@clic-ctsa.org.
 
CLICK HERE TO REGISTER

Hotel Reservations
 
A limited block of discounted rooms are available at the Hilton Crystal City for October 22 - 23. Additional Details will be included upon registering for the program meeting. The cut-off date for the discounted rate is October 1.
 
Networking & Poster Session Registration

The Fall CTSA Program Meeting will kick off with a Networking & Poster Session where each hub will have the opportunity to showcase 1-2 innovative hub projects or ideas while networking with program colleagues. Please contact your CTSA Program Official with any questions.

CLICK HERE TO REGISTER YOUR POSTER (due October 1).
ADMINISTRATORS GROUP
Quarterly Calls

We are pleased to bring back the CTSA Program Administrators quarterly webinars/calls starting this September, supported by CLIC. They will be held on the third Wednesday of the month from 1:00 – 2:00 p.m. ET beginning on September 19. REGISTER NOW.
 
Face-to-Face Meeting

The registration for the CTSA Program Administrators’ Face-to-Face Meeting, taking place October 22 prior to the 2018 CTSA Program Fall Meeting, is now open! CLICK HERE TO REGISTER.


Full details and a draft agenda from NCATS/CLIC can be found on the CLIC site. More details are forthcoming. 
CTSA PROGRAM PI MONTHLY WEBINARS
The next PI Webinar will take place on September 26. The following items are currently on the agenda:
  • CLIC Announcements
  • Relationship between HL7 International and CTSA Program - Dr. Ed Hammond (Duke CTSI) & Dr. Chuck Jaffee (CEO HL7 International)
  • D&I Science Activities Across CTSA Program Consortium: The PI survey results - Dr. Rowena Dolor (Duke CTSI)
To join these webinars, simply click on this link to register. For more information, visit the CLIC site. Please note that the October 24 and December 26 PI Webinars have been cancelled.
CLIC UPDATES
 
NOW AVAILABLE: TWO COLLABORATIVE FUNDING OPPORTUNITIES
CLIC is pleased to announce two funding opportunities for collaborative efforts to help advance translational and team science throughout the consortium. Teams are invited to apply for support to host an Un-Meeting or write a Synergy Paper.
 
Un-Meetings
 
These are events without the rules and structure of traditional conferences. Attendees create and drive the agenda and discussions based on a common theme. The selected applicant will receive funds to support an expected one day Un-Meeting in early 2019, along with planning guidance and materials from CLIC.
 
Synergy Papers
 
These papers are intended to present new or transformed assessments and perspectives, build collaboration within and external to the CTSA Program consortium, and meet the academic needs of co-authors to produce high quality scientific publications. The selected team will receive one year of assistance from CLIC for developing and publishing a Synergy Paper.
 
More information and all application requirements can be found on CLIC’s website:
Questions can be directed to unmeetings@clic-ctsa.org or synergy_papers@clic-ctsa.org.
NEW GUIDANCE ON SURVEYS
CLIC has posted a CTSA Program Process Guidance for Surveys document to their CLIC Distributed Surveys page. This document provides guidance for the generation, design and deployment of surveys within the CTSA Program. At a high level ALL surveys that are distributed to the CTSA Program consortium though either an NCATS owned or CLIC listserv require preapproval prior to distribution. Please follow the rubric located in the Guidance document or contact CLIC at surveys@clic-ctsa.org for assistance in survey development and/or distribution. 
CLIC NEWS ROUNDUP
CLIC's bi-monthly news roundup shares clinical and translational science news from CLIC, CTSA Program hubs, and the science and research worlds. Within these roundups are ‘Click to share’ options for Facebook and Twitter, allowing you to easily share CTSA Program-related news to your personal and professional social media pages.
 
If you are not currently receiving these roundups and would like to, simply click ‘Subscribe to CLIC News Roundup’ on the CLIC News page. If you have updates you'd like to see included in future roundups, please email CLIC Communications for consideration.
COMMON METRICS UPDATES
 
REVISED HUB-SPECIFIC REPORT ON 2016 COMMON METRICS DATA 
Based on hub comments, we were able to update and provide hubs with a revised 2016 report and slide deck in August. We are grateful for this initial feedback as it illuminated considerations in how CLIC received the data from the vendor and variations in how hubs are reporting certain data, some of which we were able to address in these revised reports. 
 
This first report involved a tremendous amount of data cleaning and managing to arrive at a usable data set, which led to layers of additional data discovery. We will continue this iterative process of discovery and improvement as we work to make these reports as useful as possible. 
 
We want your feedback!
 
A 2016 hub report feedback link has been sent to PIs, Administrators, and Common Metrics leads. Please check your email. The results of this feedback will be used to inform the 2017 data analyses and report. Please submit your feedback by September 26.

2017 COMMON METRICS DATA REVIEW AND ANALYSIS
Thank you for submitting your 2017 data! Our goal is to provide the consortium with timely annual reports. Your submissions by the deadline help CLIC achieve this goal. We have now received your data from Clear Impact, and our team has begun to review. Data analysis discussions are underway. Stay tuned!

LAUNCH OF THE INFORMATICS COMMON METRIC 
The Informatics Common Metric launched on September 10 with the first kick-off call. The audiences for these calls are hub Common Metrics leads and/or Informatics leads. Details about the implementation of this new metric have been sent to these hub contacts. Recording of the calls will be uploaded to the metric Google Drive collaborative space (the appropriate leads have received this link). This series of webinars follow a linear process for implementation starting with guidance about hub team formation followed by selection of data models, description of data model scripts and reporting requirements. The CLIC Common Metrics team will be supporting the hubs at every step.
DOMAIN TASK FORCE (DTF) UPDATES
 
LIFESPAN INTEGRATION DTF 
Join the Lifespan DTF Writing Group
 
The Lifespan DTF is seeking members who are interested in participating in their DTF’s writing group. The goal of this group is to identify a unifying definition of life course research and articulate recommended priorities to conduct high quality life course research.
 
Heidi Hanson (Utah) and Shari Barkin (VUMC) from the Lifespan DTF will co-lead this project. The goal of the paper would be to establish 3 – 6 priority areas for life course research across CTSA Program (or perhaps broader) sites:
  • These areas would be consistent with the CTSA Program goals
  • Narrow enough to have achievable outcomes within 5 – 10 years
  • Encourage collaboration across CTSA Program sties
  • Encourage multi-disciplinary collaborations
  • Take advantage of existing resources
  • If possible, pick one or two that have paradigm shifting potential
  • An area would only be selected if there are actionable items for translating research in that domain into clinical care
  • Special emphasis on vulnerable populations 
 
If you are interested in being part of this writing group, please email lifespan_dtf@clic-ctsa.org before September 24, 2018. The first writing group call is scheduled October 4, 2018, 11 am EST.
UPDATES FROM OTHER CTSA PROGRAM INITIATIVES
 
ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK
The ACT Network welcomes Vanderbilt and Mayo to the ACT production network. Their data is now “queriable” across the network. An additional 12 sites are onboarding to the production network throughout August. ACT has also kicked off technology implementations with 13 additional sites, who will be ready to onboard to the production network in January 2019. 
 
We encourage you to learn more about ACT on our national website. If you are interested in registering for the ACT monthly newsletter, please sign up here.
 
Questions?  Contact Elaina Sendro

TRIAL INNOVATION NETWORK (TIN)
Upcoming Webinars
  • REDCap – New Modules Supporting eConsent + EHR workflow and data interoperability
    • September 19, 2018, 12:00 p.m. ET
    • This webinar will provide an overview of new features in REDCap to support electronic consent using REDCap’s new e-Consent Framework module, which allows users to add an e-Consent confirmation screen to their surveys while also providing automatic backup of the PDF e-Consent file.
    • Register
  • Effectiveness and Cost of Recruiting Participants to a Research Registry Using an Emergency Department Research Associate (EDRA) Program
    • October 1, 2018. 12:00 p.m. ET
    • This presentation will cover a novel way to recruit volunteers into a research registry using an Emergency Department Research Associate Program. The methods and results of a pilot study using this program will be presented.
    • Register
  • DSMB operations: Nuggets for investigator-initiated clinical research
    • November 14, 2018, 12:00 p.m. ET
    • Historically, guidelines and policy for data and safety monitoring boards have focused on their operations for large multi-center clinical trials; however, there exists and need for their inclusion in and understanding of their function for a variety of investigator-initiated studies. A CTSA-based DSMB workgroup has devoted its energies to provide guidance in this niche for DSMBs and for individuals who may serve on them.
    • Register
  • The Trial Resource Pack: Best Practices and Tools for Recruitment and Retention
    • December 19, 2018, 12:00 p.m. ET
    • In this webinar, we will present a manual of best practices for optimizing clinical trial design and increasing awareness and enthusiasm for participation as well as a toolkit of customizable templates, how-to guides and educational handouts for supporting patient recruitment and retention.
    • Register

Submission Proposals

Planning to submit your proposal to the TIN? Our new “Using the Trial Innovation Network to Plan Your Trial” webpage provides a snapshot of what to expect after a proposal submission, along with guidance about when proposals should be submitted optimally. Learn more about the proposal submission process here.

For the latest updates from the TIN, sign up for our monthly newsletter.

Questions?  Contact Terri Edwards

RECRUITMENT INNOVATION CENTER (RIC)
Spotlight on RIC Tools and Services: Recruitment and Retention Toolkit   
 
Submissions to the recruitment and Recruitment Retention Toolkit can be accepted from CTSA Program hubs and reputable community health partners and are provided as a free resource to the research community. The materials in the toolkit are designed primarily for the CTSA Program staff and institutions participating in the TIN. Other parties conducting engagement, recruitment, and retention activities for clinical trials and multi-site studies are welcomed to adopt these resources for local use as well. These resources are intended to provide a variety of information that include the best evidence-based recruitment information and some that may be evidence-informed.
 
You can access the RIC Toolkit or submit a resource to share with your fellow CTSA Program colleagues by following the hyperlinks below:
The Special (Target) Populations Toolkits is also now available within the RIC Toolkit. This resource, from the University of Illinois at Chicago, is for researchers who would like to work with populations facing health disparities and under-representation in research, such as people with disabilities, urban youth, and members of LGBT, African American, and Latino communities.

Questions?  Contact Mary Stroud

IRB RELIANCE EXCHANGE (IREx)
IREx is a freely available, web-based portal that supports single IRB documentation and communication for multi-center clinical trials. IREx is the platform used by the TIN CIRBs to support all TIN projects. IREx is also used for non-TIN studies.
 
IREx is used to implement single IRB reliance by:
  • Standardizing the reliance process across sIRBs and multi-site studies
  • Harmonizing sIRB data collection (local considerations)
  • Complementing and integrating with local IRB systems
  • Establishing a central portal to capture all information needed before sIRB review:
Questions?  Visit the IREx website or contact IREx via email.

NATIONAL CENTER FOR DATA TO HEALTH (CD2H)
Great Turnout for Software Community Workgroup Show and Tell
Thank you to those who joined us on September 7 for the first Show and Tell meeting of the Software Community Workgroup. Attendees joined the webinar for updates on the Workgroup’s progress and a discussion on CD2H’s collaborative efforts to facilitate development and sharing of software, tools and algorithms across the CTSA Program. CD2H received valuable input and feedback from the community that will help shape future priorities for the Workgroup. Slides of the presentation can be viewed here and the recording here.
 
Workshop on Managing Translational Informatics Projects
 
On Friday, Sept. 21, CD2H will host a one-day workshop in Portland, Oregon, for leaders or managers of cross-functional, distributed teams that develop code or analyze data across the translational divide. Remote participation options are available. In this hands-on training, we’ll familiarize participants with tools and techniques and help provide guidance on how to select the best resources for their particular needs. The workshop is open to anyone; priority will be given to Informatics program and project managers, as well as PIs that may function in this role. There’s no cost to attend and no prior knowledge is required, however you must pre-register.
 
Upcoming Events
 
We have a busy fall calendar with multiple opportunities for CTSA Program members to collaborate and contribute ideas, expertise and input. Your participation and feedback are critical for informing the CD2H's work, so we hope you'll join us. Here are some of the important events in September and October:
 
 
Subscribe to the CD2H Newsletter
 
Have you signed up for the CD2H Newsletter? It's your best way to stay up to date on the latest news and developments from the CD2H as we work to support and accelerate collaboration and innovation across the CTSA Program informatics ecosystem. Subscribe here and also be sure to follow us on Twitter at @data2health.
 
Questions?  Contact Sarah Biber
ANNOUNCEMENTS
 
A full list of NCATS announcements and opportunities can be found here: https://ncats.nih.gov/funding/open.
 
REQUEST FOR INFORMATION (RFI): REGISTRATION AND RESULTS REPORTING STANDARDS FOR PROSPECTIVE BASIC SCIENCE STUDIES INVOLVING HUMAN PARTICIPANTS  

This RFI seeks additional input from stakeholders throughout the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants.
 
See Guide Notice NOT-OD-18-217 for more information. Responses must be submitted by: November 12, 2018 11:59:59 PM ET. To submit your comments click here.

NCCIH SUPPLEMENTS TO NCATS CTSA PROGRAMS FOR SCHOLARS PURSUING COMPLEMENTARY HEALTH RESEARCH CAREER DEVELOPMENT 

The purpose of the National Center for Complementary and Integrative Health (NCCIH) Administrative Supplement to the National Center for Advancing Translational Sciences (NCATS) supported Clinical and Translational Science Awards (CTSA) program is to develop a pipeline of qualified clinician-scientist investigators with complementary and integrative health degrees conducting clinical and/or translational research on complementary interventions for NCCIH high-priority research topics. Funding for these supplements will be provided by NCCIH.  

NCCIH will host a technical assistance webinar on Tuesday, October 2, 2018 from 2 - 3 p.m. ET. The webinar will review the funding opportunity in detail and answer questions from potential applicants. Please register for the webinar here and provide any advance questions via email to NCCIHwebinarQ@mail.nih.gov.

For more information follow PA-18-920.

UPDATE ON NIH’S NEXT GENERATION RESEARCHERS INITIATIVE (NGRI) POLICY ON EARLY ESTABLISHED INVESTIGATORS (EEIS) 
The purpose of this notice (NOT-OD-18-214) is to update NIH’s Next Generation Researchers Initiative (NGRI) policy (NOT-OD-17-101) as it relates to Early Established Investigators (EEIs).
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) on the CLIC website.
 
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 PI Webinar Webinar Registration**

Please note that the October 24 and December 26 CTSA Program PI Webinars have been cancelled.

*CLIC will post meeting summaries from the S/C calls onto the CLIC-CTSA Program website and continue to circulate monthly CTSA Program newsletters with important project-level updates and consortium activities.
 
**To add the PI 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.

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