2017.12.8 CTSA PROGRAM UPDATE

CTSA PROGRAM UPDATE

December 8, 2017

CTSA PROGRAM Updates

    WELCOME NEW DCI DIRECTOR Beginning December 10, 2017, Michael G. Kurilla M.D. Ph.D., will become the NCATS director of Clinical Innovation. His new role will include leading the CTSA Program, which supports innovative solutions that advance the efficiency, quality and impact of translational science with the ultimate goal of getting more treatments to more patients more quickly. Dr. Kurilla holds a Ph.D. in microbiology and immunology as well as an M.D. from Duke University, and was a postdoctoral research fellow at Harvard Medical School, and completed a residency in pathology at Brigham and Women’s Hospital. He is currently director of the Office of BioDefense, Research Resources and Translational Research at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), where he also has been involved with biodefense product development. Read more on NCATS website.

     

    PROGRAM GUIDANCE

    2018 Guidelines for Research Performance Progress Reports (RPPRS)

    The CTSA Program specific instructions for RPPRs is now available on the NCATS CTSA Program consortium website. To access the appendices, you must download a copy of the PDF and view the attachments of the PDF.

     

    Several updates have been incorporated:

    For the UL1:

    • Updates to the Table for Institutional Collaborators to clarify the definition of a collaborator (reported under G.1)
    • Research supplements to promote diversity and re-entry awardees will be required to report under G.1 to allow the institution to provide more descriptive information and to use the updated Training Individual Progress Report (reported under G.1)
    • Updated instructions for reporting of workforce development externships (reported under G.1)
    • Updated reporting requirements for pilot projects (reported under G.1)

    For the KL2 and TL1:

    • A reminder to include Table 8 (A, B and/or C) to reflect new appointments and other changes over the reporting period and that institutions can use xTRACT to generate these tables
    • Supplements that have been provided to the KL2 to support scholars pursuing dental, oral and craniofacial clinical and translational research career development (RFA-DE-17-008) must use the Training Individual Progress Report to report progress (reported under G.1)
    • Updates to the suggested Training Individual Progress Report form to include a report on externships that the trainee or scholar has participated in

    If you have specific questions that cannot be addressed with these instructions, please submit your questions via email to, CTSARPPRQuestions@mail.nih.gov.

     

    Notice of importance;

    The Project Outcomes Section of all Interim and Final RPPRs Submitted on or After October 1, 2017 are available via the NIH RePORTER

     

    Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109)

    Effective Oct 1, 2017, NIH will automatically issue Certificates of Confidentiality to all research funded by NIH that is collecting or using identifiable, sensitive information. These new disclosure rules apply to everyone. These Certificates protect the privacy of subjects by limiting the disclosure of identifiable, sensitive information. Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is deemed to be issued a certificate through this policy and is therefore required to protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act. Notably, in accordance with NIH Grants Policy Statement Chapter 15.2.1, grant recipients are responsible for ensuring that any sub recipient that receives funds to carry out part of the NIH award involving a copy of identifiable, sensitive information protected by a certificate issued by this policy understand they are also subject to subsection 301(d) of the Public Health Service Act. With respect to the CTSA Program hubs this includes KL2 scholar projects and pilot projects. For more information see Certificates of Confidentiality for NIH Funded Research.

     

    Have a CoC Question?

    Please address your inquiries to: NIH Office of Extramural Research

     

    COMMON METRICS

      COMMON METRICS PAGE ON CLIC WEBSITE

      The CLIC Common Metrics page is now live. We invite you to visit the site. Many of the training and metric materials from the Tufts University website can now be found on the CLIC website. We will continue to populate with Common Metric updates and new materials.

       

      ACCRUAL METRIC PILOT TEST UPDATE

      The every other week webinar component of the pilot test was completed, with participating hubs calculating an Accrual Metric value and describing an initial Turn-the-Curve (TTC) plan. Each hub is now completing a survey about their experience with the metric and Operational Guideline. Principle Investigators and hub teams will also participate in key informant interviews this month.

       

      INFORMATICS COMMON METRICS PILOT UPDATE

      Sixteen sites were selected to participate in the Informatics Common Metric pilot. The pilot kick-off call occurred on November 17, 2017. A survey of all hubs was done as part of the pre-pilot work; the overall results were provided to the Informatics DTF on December 1, 2017 and will soon be available on the CLIC Common Metrics page.

       

      COMMON METRICS INITIATIVE TECHNICAL ASSISTANCE TRANSITION TO CLIC

      As of December 1, 2017, CTSA Program hubs can request technical assistance for the IRB Duration, Pilot Funding, and Careers in CTR metrics and the Scorecard system.

       

      Questions? Contact CLIC Common Metrics implementation team at common_metrics@clic-ctsa.org or by phone 585-276-4817.

       

      DOMAIN TASKFORCE (DTF) UPDATE

        ELECTIONS

        The election process to identify new DTF Lead Team members are in progress. We will be announcing the new DTF leadership in next months update.

         

        CLIC WEBSITE REGISTRATION

        You MUST REGISTER on the CLIC website to access DTF/WG meeting materials. If you have trouble doing so, please contact your DTF/WG CLIC Coordinator, Liaison, or the CLIC helpdesk.

         

        COLLABORATION/ENGAGEMENT DOMAIN TASKFORCE

        Joint Workgroup for Researcher Education & Training and Community Capacity Building Joint Workgroup: has (1) conducted a pragmatic literature review of curricula and training resources for researchers in engaging communities and for community partners and stakeholders in translational research; (2) developed an inventory of existing curricula and training resources and a competency framework for mapping the curricula and resources (using a modified Delphi technique); and (3) begun a gap analysis of important areas requiring further development based on the competency framework. They anticipate preparing these for publication, distribution, and dissemination over the next quarter.

        Methods to Assess Community Engagement Strategies Workgroup:  The three integrated sub workgroups with between 4 and 12 members in each group.

        The literature review sub-workgroup has identified approximately 50 community-engaged reviews of the literature. This review of the literature, along with surveys previously used to assess community academic collaborations, will be used to create a new survey to be administered to each CTSA. The strategy for administering and piloting the survey will be led by the protocol sub-workgroup.

        Three products are planned: (1) a paper based on the literature review that updates and expands on prior reviews; (2) a survey that will be used to document the various barriers and facilitators to established community partnerships; (3) a paper reporting on the results and how well CTSA practices align with or advance what is in the published literature.

        Collaboration/Engagement DTF questions? Please contact help@clic-ctsa.org.

         

        INFORMATICS DOMAIN TASKFORCE

        Will meet in person Friday, March 16th, directly following the American Medical Informatics Association (AIMA) Summit.

        Informatics DTF questions? Please contact help@clic-ctsa.org.

         

        LIFESPAN DOMAIN TASKFORCE

        The Lifespan domain taskforce has identified building a toolkit for lifespan researchers as a goal. Potential components of the toolkit includes; (1) providing consultation to an on-going large-scale NIH-funded project that spans adolescence to geriatrics, (2) the MoTrPAC study (molecular transducers of physical activity in humans program) which will allows us to identify what new tools are needed to add to the field.

        Early Life Exposure Workgroup:  The workgroup completed a REDCap survey inventory of existing lifespan databases across all the CTSA Program hubs and submitted a manuscript of these findings to Clinical and Translational Research. The goal is to find a shared location to make links to existing resources easily accessible to lifespan researchers. This workgroup has also consulted with the All of Us (Precision Medicine Initiative) to discuss module considerations for capturing exposure to early life events for adults being enrolled.

        Single Disease Workgroup: This workgroup is preparing a white paper to examine transitions of care for both sickle cell disease and cystic fibrosis and plan to submit them for publication in early 2018. They have involved community members and obtained organizational input from the Cystic Fibrosis Foundation.

        Aging Workgroup:  This workgroup is preparing a survey in an effort to assess existing databases for middle and older adults and has expanded their efforts to include researchers affiliated with the Pepper Centers on Aging.

        Lifespan DTF questions? Please contact help@clic-ctsa.org.

         

        METHODS AND PROCESSES DOMAIN TASKFORCE

        EMR-based Research Recruitment Workgroup: This collaborative team from the Informatics and Methods & Processes DTFs has published the paper “A Survey of Practices for the Use of Electronic Health Records to Support Research Recruitment“. The paper describes the results from a survey of consortium members regarding current practices in the use of EHRs in the recruitment of research subjects and to propose future potential directions. One outcome was the identification of a need for comparative research and development of best practices to protect patients and facilitate inter-institutional collaboration and multisite research. The abstract is available on the Journal of Clinical and Translational Science website.

        Methods and Processes DTF questions? Please contact help@clic-ctsa.org.

         

        WORKFORCE DEVELOPMENT DOMAIN TASKFORCE

        Workforce Development DTF questions? Please contact help@clic-ctsa.org.

        OPPORTUNITIES

          NEW NIBIB-CTSA TRAINING PARTNERSHIP

          NIBIB and NCATS announce the availability of NIBIB Supplements to NCATS CTSA Programs for Translational Research Teams of Quantitative Researchers and Clinician-Scientists (Admin Supp)

           

          This program aims to facilitate partnerships where a clinician-scientist and a quantitative researcher, with a background in engineering or the computational or physical sciences, will team up to conduct a translational science research project. The project is expected to be jointly conceived and require significant contribution from both candidates. The quantitative researcher should have an expressed interest or history in, conducting translational science and currently hold the position of tenure- or research-track assistant professor or similar faculty position. The partnering clinician-scientist should hold an M.D. or M.D./Ph.D or equivalent degree and should also have a demonstrated interest or history in conducting translational research. The supplement request should include appropriate clinical and basic research mentors to provide guidance for the translational research project and the career development of the researchers.  The supplement will provide salary and research support to the quantitative researcher who is expected to devote a minimum of 9 person-months (75% of full-time professional effort) to this project. The clinician-scientist is expected to be appointed to the parent KL2 at the time of application or planned to be appointed to the program if the supplement is funded.

          For more information, refer to PA-18-426 or contact Dr. Zeynep Erim

          ANNOUNCEMENTS

            SAVE THE DATE – SPRING CTSA PROGRAM MEETING

            The Spring CTSA Program meeting will be held the afternoon of April 18, 2018 following a morning meeting of the Steering Committee. Participation for this year’s Spring Program meeting will be limited to the U01, KL2 and TL1 PIs. In-person DTF meetings will be held on April 19, 2018, prior to the start of the Association for Clinical and Translational Science annual meeting. Look for more information to come after the holidays!

             

            MEETING< ON CLIC WEBSITE/span>

            CTSA Program hubs can find information about meetings and events on the Events page on the CLIC website, this page was created to spread the word about hub-sponsored conferences, activities, and/or items relevant to the CTSA Program and the advancement of translational science. If you would like to showcase an event please fill out this event form form the CLIC website.

             

            Recent additions are listed below. Please click the Event Name for more information!
             

            Date Institution/Organization Event Name
            December 6–7, 2017 University of Pittsburgh Clinical and Translational Science Institute HHS Opioid Symposium & Code-a-Thon
            December 12, 2017 Penn State University Using Twitter Data for Social, Demographic, and Behavioral Science Research
            December 11–13, 2017 Northwestern University Bibliometrics and Scientometrics for Research Evaluation
            March – April 2018 University of Michigan FFMI fastPACE Train-the-Trainer Course
            April 18, 2018 NCATS Spring CTSA program meeting
            April 19-21, 2018 Washington Marriott Wardman Park in Washington, DC Association for Clinical and Translational Science Annual Meeting
             May 21-24, 2018 University of Texas Medical Branch in Galveston Science of Team Science (SciTS) 2018 Conference

             

            Questions? Contact help@clic-ctsa.org

             

            Upcoming NCATS Events
            Event Date Location
            CTSA Program Steering Committee Webinar 12/11/2017*, 1/8/2018**

            Second Monday of the month;

            2:30 – 4 p.m. ET

             

            * The CTSA Program Steering Committee will hold “executive” meetings for these Steering Committee calls.

            Please stay tuned for Steering Committee updates from your Pod leader.

             

            **CLIC will manage Steering Committee meetings beginning with 1/8/18 call (TBD whether an Executive session)

            		 Webinar
            CTSA Program PI Webinar 12/27/2017 (cancelled), 1/24/2018*

            Fourth Wednesday of the month;

            2 – 3 p.m. ET

             

            * CLIC will take over management of calls in January – details to follow.

             

            		 Webinar

             

             

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