11.9.18 CTSA PROGRAM UPDATE

Note: The Program Update now has a ‘clickable’ Table of Contents and a ‘Return to Top’ feature, allowing readers to easily navigate through the content and jump to various sections of the newsletter. If you have any trouble with these features, please select the option to ‘View this email in your browser.’

 

TABLE OF CONTENTS

 

 

CTSA PROGRAM UPDATES

 

SAVE THE DATE: 2019 SPRING CTSA PROGRAM GROUP MEETINGS

The 2019 Spring CTSA Program Group Meetings will be taking place March 4 – 5, 2019 at the Marriott Wardman Park Hotel in Washington, D.C. Established meetings:

  • Collaboration & Engagement DTF
  • Communications
  • Methods & Processes DTF
  • KL2 Principal Investigators
  • TL1 Principal Investigators
  • Workforce Development DTF

Additional details will be available on the CLIC website soon!

 

NOTICE OF CHANGE TO PAR-18-940 CLINICAL AND TRANSLATIONAL SCIENCE AWARD

This notice amends PAR-18-940 with updates to the Key Dates, Informatics component, Network Capacity component, and the Institutional Career Development Award.  Instructions are effective for due dates on and after January 25, 2019.

For more details please go to NOT-TR-19-010.

 

SEEKING NEW STEERING COMMITTEE MEMBERS

NCATS is seeking nominations for new CTSA Program Steering Committee (SC) members! We have 5 total slots available – 4 UL1 PIs and 1 Administrator SC member. If you would like to self-nominate or suggest a fellow PI, please submit the PI name, institution, and brief explanation (no longer than 1 paragraph) to Samantha Jonson (Samantha.Jonson@nih.gov) by Friday, November 30.

The eligibility criteria for SC appointments for PIs (UL1, KL2 and TL1) and an Administrator are as follows:

  • A PI must be officially named in the Notice of Grant Award of an active CTSA Program hub
  • An Administrator is the key point of contact between their institution’s CTSA Program leadership and Program Directors, and NCATS personnel
  • An “active” award is defined as a hub award that is not in a No-Cost Extension (NCE). A PI or Administrator whose hub award in an NCE is not considered eligible as there is insufficient time remaining in the award project period for initiation of an appointment.
  • For both PIs and Administrator, their hub award must have at least 3 years remaining during the project period
  • An eligible PI has not served on the SC since December 2014

To learn more about the roles and responsibilities, please visit this web page.

 

2019 RESEARCH PERFORMANCE PROGRESS REPORT SPECIFIC GUIDELINES FOR THE CTSA PROGRAM

We have updated our Specific Guidelines for Research Performance Progress Reports (RPPRs) for the Clinical and Translational Science Awards (CTSA) Program. The updates include additional instructions and timelines for Final RPPRs, as well as, reporting on current areas of strong public interest (e.g. health disparities, minority health, rural health outcomes, opioids, pain, etc.) as requested by Congress.

For a complete list of updates and to access the updated RPPR instructions, please click here. For questions related to the CTSA RPPR Guidelines please email us atCTSARPPRQuestions@mail.nih.gov.

 

CTSA PROGRAM PI MONTHLY WEBINARS

The next PI Webinar will take place on November 28. As a reminder, the December 26 PI 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. REGISTER NOW.

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

 

EXPLORE THE CLIC FORUM

Check out the CLIC Forum today! Program members can use the forum to ask the consortium questions, discuss best practices, bounce ideas off each other and share opportunities. We encourage you to explore the platform, begin sharing ideas and thoughts, and reach out to us with any questions. Please note that you must be logged into the CLIC website to access the forum’s functionality.

 

CTSA PROGRAM COMMUNICATIONS GUIDANCE DOCUMENT

In an effort to clarify the different avenues for sharing, submitting and amplifying CTSA Program-related communications through NCATS and CLIC, a CTSA Program Communications Guidance Document has been created.

You can access this document a variety of ways: it’s listed on CLIC’s News page and in CLIC’s Communications Toolkit (remember to login to access), and is included on NCATS CTSA Program webpage.

 

 

COMMON METRICS UPDATES

 

USING THE CLIC FORUM FOR COMMON METRICS DISCUSSIONS

CLIC recently launched a forum as a place for you to ask the consortium questions, discuss best practices, bounce ideas off each other and share opportunities. More specific to our Common Metrics Initiative and your CM hub role, there is an established Common Metricscategory. We have created four threads to start: 2017 CMI Data Submissions;Comments/Questions on Informatics Metric?; 2016 CMI Hub Reports; and Communities of Practice Interest. Be sure to subscribe to each thread to be notified of new updates. You may also add or suggest additional CM threads.

 

COMMON METRICS COMMUNITIES OF PRACTICE FORUM

Our team has brainstormed ways to gather interested CM parties together to discuss metrics, the initiative, or other specific areas of the CM. We would like to assess consortium interest in participating in such a community group. In this thread, please share whether you would be interested, ideas for the topics of focus, and how the group(s) should be structured (ex. quarterly calls, via the forum, or other). Examples of topics include: metric operational guidelines, TTC Plan lessons learned, best practices to improving a particular metric. Please share your opinion on the thread link Communities of Practice Interest.

 

INFORMATICS COMMON METRIC UPDATE

CLIC would like to thank all of the hubs who joined us for the Informatics Metric webinars and office hours. To date, there have been four webinars and four office hours and the participation has been outstanding with 61 unique hubs and 174 individuals registered. The last Office Hour is scheduled for Monday, December 10. Please do not hesitate to contact us if you have questions regarding your Informatics Metric implementation –common_metrics@clic-ctsa.org. Visit our website for metric details: Established Metric Information.

 

DOMAIN TASK FORCE (DTF) UPDATES

 

COLLABORATION & ENGAGEMENT DTF

Elections for the Collaboration & Engagement DTF Lead Team

Elections will occur in November, so please think about nominating someone or self-nominating. Additional details regarding the election process will be sent via email. We will be looking to fill 3 open slots to serve a term of two years. Louisa Stark has accepted the lead team’s nomination as the elected co-chair for next year; Sergio Aguilar-Gaxiola, Syed Ahmed and Tabia Henry Akintobi will rotate off the Lead Team. Thank you to Sergio, Syed and Tabia for your years of service!

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.

 

METHODS & PROCESSES DTF

Institutional Readiness Team Science WG

The Great CTSA Team Science Contest winners were announced at the Fall Program Meeting. The work group will begin the Qualitative Analysis and will write a manuscript/and or white paper with the possibility of publication. In addition, they will also be determining whether the contest will become a reoccurring event.

Regulatory Science to Advance Precision Medicine WG 

A writing team is now being formed to develop a manuscript and/or white paper building off of the results of the Fall Forum held in September.

 

INFORMATICS DTF

Save the Date! The Informatics DTF Annual Face-to-Face Meeting will take place on Friday March 29, 2019 in San Francisco from 7 a.m. – 1 p.m. PT.

The agenda will most likely include updates from the six Informatics WGs – 3 iDTF, 3 CD2H. Let us know what else you’d like to discuss via the REDCap survey sent out on Monday, November 5 or email the Informatics DTF via informatics_dtf@clic-ctsa.org.

Workgroup Status

There are three new iDTF WG charters for the following proposed workgroups:

  • Enterprise Data Warehouse
  • Sustainability Phase Two
  • Text Analytics and De-Identification

These are awaiting formal approval from the CTSA Program Steering Committee. We hope to hear from the Steering Committee by the end of November.

Election Update

No elections will be held for the Informatics DTF for 2019. The members of the iDTF Lead Team agreed that, for continuity’s sake with new WGs and changes happening, Dr. Peter Tarczy-Hornoch will continue to serve as the co-chair for another year and Dr. Chunhua Weng will continue for another year to serve on the Lead Team.

 

 

UPDATES FROM OTHER CTSA PROGRAM INITIATIVES

 

ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK

To allow investigators to receive patient counts in real time from each participating institution, the Accrual ACT Network has upgraded its SHRINE software to enable asynchronous query responses – this change reduces wait time for ACT query results and allows more efficient testing/refinement of eligibility criteria for clinical studies. In addition, the ACT Executive Committee is meeting this month to outline plans for 2019. To stay up to date on 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

 

TRIAL INNOVATION NETWORK (TIN)

TIN has many ways for you to stay engaged with the latest tools, resources, and events. See below for ways to stay connected and for opportunities to collaborate with the Network.

Stay Connected

  • Sign Up for the Monthly Network Newsletter – Look for the “Let’s Keep In Touch” section
  • Find Upcoming Network Events
  • Download Recruitment & Retention Tools

Collaboration Opportunities

  • Present your expertise through our Collaboration Webinar Series
  • Share your Recruitment & Retention tools and resources

TIN continues to accept proposals for multi-site clinical trial and study collaborations. Submit your proposal here.

Upcoming Webinars

  • DSMB operations: Nuggets for investigator-initiated clinical research
    • November 14, 2018, 12:00 p.m. ET
    • Register
  • 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)

Community Advisory Board in person Meeting

On October 29, the RIC Community Advisory Board (CAB) met in Salt Lake City, Utah for the bi-annual in-person meeting. The CAB welcomed two new members, representing Native American and Asian communities. The CAB was joined by University of Utah colleagues from the CCTS Collaboration and Engagement Team, the Utah Trial Innovation Center, and the TIN Patient, Providers, Public Working Group.  Each provided an overview of their respective roles and projects. Key elements of discussion during the day included developing guidelines around community engagement to facilitate participant enrollment (including a recruitment plan template), enhancing national awareness of clinical trials, methods for RIC leadership to seek ongoing feedback from key community stakeholders (e.g. community providers, patients) and informing funders about best practices for improving enrollment of minorities in clinical trials.

Questions?  Contact Mary Stroud

 

IRB RELIANCE EXCHANGE (IREx)

IREx Streamlines Sign On Process – Portal Agreement Not Required

When IREx launched in February 2017, an Institutional Official had to sign off on a portal agreement to gain access. This process has been phased out and IRB Directors or Managers can now create their institutional access using this link on IREx website. Similar to other web-based platforms, user access is governed by clickable terms of use. IREx is currently being used by 61 CTSA institutions (view all members here).

Questions?  Visit the IREx website or contact IREx via email.

 

NATIONAL CENTER FOR DATA TO HEALTH (CD2H)

CD2H Community Engagement at the Fall CTSA Program Meeting

The CD2H enjoyed multiple opportunities to engage with the community at the 2018 CTSA Program Fall Meeting, including the inaugural meeting with our CTSA PI Focus Group on Monday, Oct. 22; and a presentation by CD2H leadership team members Melissa Haendel, Sean Mooney, and Sarah Biber during the afternoon session on Opportunities for CTSA Program Hub Engagement with CD2H.  The CD2H also shared our new two-page program overview widely at the meeting. Recaps of the PI Focus Group Meeting and afternoon session are available at the CD2H blog.

Announcing: DREAM Challenge Ideation Competition

The CD2H is excited to announce the launch of the first-ever CTSA DREAM Challenge Ideation Competition. One selected project will be awarded a $100,000 subcontract to complete the Challenge in partnership with the CD2H. Stay tuned more details in CD2H’s monthly newsletter in mid-November.

Stay Current, Subscribe to the CD2H Newsletter

Have you signed up yet 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. Subscribehere and also be sure to follow us on Twitter at @data2health.

Questions?  Contact Sarah Biber

 

SMART IRB

SMART Essentials

The Implementation Checklist highlights flexible provisions of the SMART IRB Agreement and documents which provisions will be implemented for a specific study. Equip study teams: our Overall PI (and Lead Study Team) Checklist and Relying Site Investigator Checklist help study teams understand their responsibilities in a single IRB arrangement. Get all this and more at smartirb.org/resources.

SMART IRB @ PRIM&R’s AER Conference November 14-17

Join the SMART IRB team in a range of sessions related to single IRB review (see the full agenda). Stop by our table in the exhibit hall to chat with an ambassador, ask a question, or learn more about the SMART IRB Online Reliance System.

Your Questions: Answered

Connect with a SMART IRB Ambassador. In addition to our regional ambassadors, we now have team members available to help with a range of key focus areas (research team training, community-based organizations, large healthcare systems, and more).
More information is at https://smartirb.org/ or contact: help@smartirb.org.

SMART IRB’s Online Reliance System – better and better

Relying Institutions can now upload local context and institution requirements (e.g.,Institutional Profile and Protocol-specific Document) when documenting a reliance arrangements, ensuring the Reviewing IRB has the information they need. Join the 1800+ users and 750+ studies that are already using the Online Reliance System to document their reliance arrangements.

 

 

ANNOUNCEMENTS & OPPORTUNITIES

 

A full list of NCATS announcements and opportunities can be found here:https://ncats.nih.gov/funding/open.

 

PUBLICATION OF THE REVISED NIH GRANTS POLICY STATEMENT (REV. OCTOBER 2018) FOR FY 2019

NIH has announced the publication of the revised NIH Grants Policy Statement (NIHGPS, rev. October 2018). This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. This revision supersedes, in its entirety, the NIH Grants Policy Statement (October 2017) as a standard term and condition of award. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2018.

The NIHGPS provides both up-to-date policy guidance that serves as NIH standard terms and conditions of awards for grants and cooperative agreements, and extensive guidance to those who are interested in pursuing NIH grants.

The document is available in the following electronic formats: HTML and PDF (http://grants.nih.gov/grants/policy/nihgps/index.htm). For more information please click here NOT-OD-19-021.

 

NIH SEEKS PUBLIC COMMENT ON PROPOSED PROVISIONS FOR A FUTURE DRAFT DATA MANAGEMENT AND SHARING POLICY

On October 10, 2018, NIH issued a Request for Information (RFI) in the NIH Guide to Grants and Contracts to solicit public input on proposed key provisions that could serve as the foundation for a future NIH policy for data management and sharing.  The feedback we obtain will help to inform the development of a draft NIH policy for data management and sharing, which is expected to be released for an additional public comment period upon its development.

Comments on the proposed key provisions will be accepted through December 10, 2018, and can be made electronically by visiting here.

 

 

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 Monthly Webinar Webinar Registration**

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

 

*CLIC will post meeting summaries from the S/C calls onto the CLIC-CTSA Program websiteand 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.