COMMUNICATIONS

CTSA PROGRAM UPDATE

April 13, 2018

CTSA PROGRAM UPDATES

WELCOME NEW DCI DEPUTY DIRECTOR

Beginning April 16, 2018, Clare Schmitt Ph.D., will become the NCATS Deputy Director for the Division of Clinical Innovation. Dr. Schmitt received her Ph.D. from the University of Texas in Austin followed by a postdoctoral fellowship at the Uniformed Services University with a subsequent Assistant Professorship at the same institution. She is currently the Deputy Director of the Office of Biodefense, Research Resources, and Translational Research overseeing a diverse portfolio focused on infectious disease product development encompassing the T1 / T2 space. Dr. Schmitt will attend the upcoming CTSA Program meeting and looks forward to meeting our community!

WELCOME NEW CTSA PROGRAM DEPUTY DIRECTOR
Beginning April 16, 2018, Erica Rosemond Ph.D., will become the Deputy Director of the Division of Clinical Innovation’s CTSA Program Hubs under Dr. Mary Purucker. In this new role, Dr. Rosemond will support grant operations within the CTSA Program. Dr. Rosemond received her Ph.D. in pharmaceutical sciences at the University of Toronto in Canada followed by a postdoctoral fellowship at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). She is currently a Program Director with the CTSA Program and provides programmatic direction for multiple hubs, the Center for Leading Innovation & Collaboration (CLIC) and the CTSA Program National Data to Health Coordinating Center (CD2H).

UN-MEETING: ADDRESSING THE OPOIOD CRISIS THROUGH TRANSLATIONAL SCIENCE
The National Institutes of Health (NIH) recently announced an initiative pledging resources and efforts to combat the opioid epidemic. On the heels of that announcement, the Center for Leading Innovation and Collaboration (CLIC) will host an “Un-Meeting” on Saturday, June 2, 2018 at the University of Rochester MedicalCenter to discuss how to best address opioid misuse and abuse through translational science.

Register by May 23 as space is limited. Event admission is free of charge, but interested parties must fund their own travel and accommodations.

Please note: One travel award will be available for each CTSA Program hub. For CTSA Program hub members interested in receiving travel award information, please contact your hub PI or Administrator.

CLICK HERE TO LEARN MORE & REGISTER

Questions?  Contact CLIC

CTSA SPRING PROGRAM MEETING

Date

April 18 – 19, 201

Location

Marriott Wardman Park
2660 Woodley Rd NW
Washington, DC 20008

Specific meeting agendas are linked in the table below:

CLIC UPDATES

CTSA PROGRAM COMMUNICATORS: ENVIRONMENTAL SCAN IS NOW LIVE

The goal of this Communications Environmental Scan is to learn more about what CTSA Program hub communications contacts are doing to promote their hub’s efforts, and what challenges they’re facing, so that CLIC can better help disseminate their CTSA Program-related news and messages.

This scan is completely confidential, anonymous and voluntary. The data will be analyzed in a systematic way and CLIC will share the results on their site and at a future CTSA Program Communications Meeting

We ask that hub communications contacts complete this brief (but important!) scan on or before Friday, April 27, 2018.

CLICK HERE TO PARTICIPATE

Questions?  Contact Laura Meyers

CLIC IS NOW ON TWITTER
Follow for CLIC-specific updates and content, news from NCATS and around the network, and translational science-related articles: @CLIC_CTSA.

CLICK HERE TO FOLLOW

WE WANT YOUR CONTENT!
News

CLIC has recently revamped its News page, which now features forms for both Network News submissions and CTSA Program Success Story submissions.

• If you’d like to submit Network News, simply click “Submit Network News” on the News page (you must be logged in to do so). Completed Network News forms allow CLIC to feature a summary and link to the original article, and are sent to NCATS for review.
• If you’d like to submit a Success Story, simply click “Send a Success Story to NCATS” on the News page (you must be logged in to do so). Completed Success Story forms are sent directly to NCATS for potential use in the Center’s monthly e-newsletter and possibly in other ways.

Events & Opportunities

• If you’d like to promote an event on the CLIC site, simply click “Add Event” at the top of the Events page (you must be logged in to do so).
• If you’d like to promote an opportunity on the CLIC site, simply click “Add an Opportunity” at the top of the Opportunities Board page (you must be logged in to do so).

Questions?  Contact Laura Meyers

REGISTER FOR THE CLIC SITE
If you have not already done so, directions for registering can be found here. CLIC will also have staff available at the Spring Program Meeting to help you register in-person if needed.

STEERING COMMITTEE UPDATES

LANDSCAPE ANALYSIS OF OPIOID RELATED PROGRAMS IS NOW LIVE

The goal of this landscape analysis, created by the Opioid Working Group of the CTSA Program Steering Committee, is to generate a broad landscape analysis of opioid related programs (representing either best practices or innovative programs) that are currently underway across CTSA Hubs/institutions/universities, individually or with diverse partners.

It is requested that this data collection instrument is completed on or before Monday, April 16, 2018. The WG requests only one response per institution.

CLICK HERE TO PARTICIPATE

Questions?  Contact Scott McIntosh

COMMON METRICS UPDATES

INFORMATICS COMMON METRICS PILOT

The Informatics Metric Pilot has ended. Post-pilot assessments and interviews are complete and a final summary report was submitted to the metric development team and NCATS Common Metrics Lead. CLIC is scheduling a call with the Metric Development Team to discuss recommendations and next steps. Once an agreed-upon implementation plan is developed, CLIC will deliver presentations to key stakeholder groups, prior to scale-up Consortium-wide.

MEDIAN ACCRUAL COMMON METRICS PILOT
Tufts University summarized the Pilot Study data. The final report will be shared with the Accrual Metric Development Team. Calls will be scheduled with Accrual Metric Development Working Group in the near future to discuss the report and next steps.

2016 DATA ON IRB DURATION, CAREERS, PILOTS AND PUBLICATIONS
CLIC will be presenting visualizations of the first 3 metrics collected by hubs in 2016 at the Spring CTSA meeting.

NOW ACCEPTING 2017 COMMON METRICS DATA VALUES AND UPDATED TURN-THE-CURVE PLANS!
Hubs may begin to submit their 2017 CTSA Program hub Common Metrics data reporting. This involves updating your hub’s Common Metric values through 2017, and modifying, as needed, your Turn-the-Curve (TTC) plans for the first three metrics: Careers in Clinical and Translational Research, IRB Duration, and Pilot Funding and Publications.

Updating the TTC plan includes describing: any changes to underlying factors, progress made by implementing selected strategies, and results of any additional measures your hub is using to track progress with strategies. As in the past, hubs are encouraged to work with all of their metric team members (evaluator, content expert(s), data support, and others as warranted).

August 30, 2018 is the last day for 2017 Common Metrics data submissions.

Questions?  Assistance is available from our Common Metrics team at common_metrics@clic-ctsa.org

REMINDER: CLEAR IMPACT SCORECARD LICENSE TRANSITION
On May 1, 2018, the management of the Clear Impact Scorecard Licenses for hubs will transition from Tufts University to CLIC. The number of licenses supported is also changing; CLIC will purchase two licenses per hub. The option to purchase a third license (or more) will be available. The cost is $240/user/year.

Clear Impact will email current hub license holders providing instructions on how to transition from three to two licenses and if interested, how to purchase additional licenses. In the meantime, if you have any questions about this upcoming process, feel free to contact Lauren Chambers, Impact Consultant at Clear Impact.

Questions?Contact CLIC Common Metrics implementation team or call 585-276-4817.

DOMAIN TASKFORCE (DTF) UPDATES

INFORMATICS DTF

Face-to-Face Spring Meeting

The iDTF Face-to-Face Spring Meeting recently held in San Francisco was a great success! Sixty-eight of our members attended, 20% of which completed the evaluation form and rated the overall meeting an 8.73 out of a possible 10.

The meeting had these main goals: provide the opportunity to network with informatics colleagues from across the CTSA hubs, and set up/kick off the working groups/interest groups for the iDTF and CD2H. The group discussions showed the level of interest in the various topics allowing the iDTF and CD2H facilitators to move forward from there.

The CD2H discussion group topics included:

• Software, Tools and Algorithms
• Lifespan
• Data
• Ontologies and Standards
• People, Expertise and Attribution

The iDTF breakout session group topics included:

• Funding CRI: A Complicated Matter / Sustainable Informatics Infrastructure
• Self-Service Tools for Researchers / TriNetX Experiences
• Datasets Available for Collaboration
• Improved Open Source Notes De-Identification Pipeline / Open Health Natural Language-processing Collaboratory / High Throughput Phenotyping & Text Procession

If you are interested in any of these topics, please reach out to the iDTF Coordinator at informatics_dtf@clic-ctsa.org.

Sustainability Informatics Infrastructure WG Update

At the Face-to-Face meeting, the iDTF members voted to have a breakout session to discuss topics related to the work done by the Sustainable Informatics Infrastructure Working Group. A multitude of more specialized focus areas emerged such as the development of business models and quantifying operational costs associated with different classes of services; for example, the provisioning of Electronic Health Record (EHR) data for research use and the cost of EHR-based development in support of research and clinical trial informatics infrastructure cost. These topics constitute a good trajectory for past work in this area aimed at identifying the different components of a comprehensive informatics infrastructure and current avenues of funding, whether institutional or extramural. Upcoming Sustainable Informatics Infrastructure Working Group calls will focus on these new topics and examine more specific business models for several of these components.

CENTER FOR DATA TO HEALTH (CD2H) UPDATES
Making data more meaningful, open, and accessible is a key goal in NCATS’ efforts to improve translational science. Read more about the creation of a nationwide data ecosystem through the National Center for Data to Health (CD2H) in a new featured news item from NCATS.

We invite colleagues at all CTSA hubs to get involved with the CD2H. Join a working group, follow the CD2H on Twitter at @data2health, and reach out to the project at conferences and other events. We look forward to working with you!

ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK UPDATES

ACT NETWORK NEWSLETTER

The ACT Network, a real-time platform allowing researchers to explore and validate feasibility for clinical studies across the CTSA consortium, is hosting its annual Spring Meeting for ACT participants on April 17 in Washington, DC. Following the Spring Meeting, there will be the opportunity to learn more about ACT during the CTSA Program Meeting on April 17, at the registration and break periods, in addition to the poster session at the ACTS Meeting. For general information on the ACT Network, you can reference our new website which is now live. If you are interested in registering for the ACT monthly newsletter, please sign up here.

TRIAL INNOVATION NETWORK (TIN) UPDATES
NEW REGISTRATION PROCESS FOR OPEN FORUMS

TIN Open Forum meetings are an opportunity to hear form Network Project leads on various network topics and allow you to comment and ask questions. These standing sessions are held on the third Thursday of the month. Due to the success of the networking opportunity we have “outgrown” the web conferencing, GoToTraining system that we use. The current web conference reminders have expired. Please remove them from your calendar so you have the correct link for future Open Forums.

The new process for Open Forum meetings will require registration for each session you plan to attend. Feel free to register for multiple session listed on the website. As new topics are identified and speakers confirmed new sessions will be added to the page.

Below are the instruction for how to register:

1. Access the TIN Network Events page at: https://trialinnovationnetwork.org/elements/network-events/?category=open-forums.
2. Select the Open Forum Tab.
3. After browsing the Open Forum Topics select the “Register Now” button for the session you want to register for.
4. Compete the registration fields (first and last name, email address, organization and job title).
5. The session will then be added to your Outlook Calendar.
6. To join the meeting each month open the calendar occurrence and following the “link to register.”

Please contact Wendy Lloyd if you have topics of interest to present or be presented, or if you have any questions.

WEBINAR: CLINICAL TRIAL RECRUITMENT, ACCRUAL AND RETENTION
The TIN is hosting a webinar, “Clinical Trial Recruitment, Accrual and Retention: The Role of Quality Improvement and How it can Make a Difference,” at noon on April 18. This webinar will discuss how self-assessment, process mapping and measurement can make a difference in outcomes around recruitment, retention and accrual.

CLICK HERE TO REGISTER

OPPORTUNITIES

2018 CALL FOR APPLICATIONS – NCATS / ELI LILLY EXTERNSHIP OPPORTUNITY **APPLICATION DEADLINE EXTENDED**

Deadline for 2018 NCATS / Eli Lilly Externship Program applications has been extended through April 30, 2018. Externship activities are expected to start in July 2018 at Eli Lilly in Indianapolis, Indiana. For more information about the experience, eligibility and application procedures see here.

Questions?  Contact Joan Nagel

ANNOUNCEMENTS

NEW CHECKLIST FOR PRIOR APPROVAL

NCATS has developed a new revised Checklist for requesting prior approval of delayed onset research involving human subjects (which can be found here). In addition, there is a new decision tree to assist investigators in determining when a project should be submitted for Prior Approval. We are currently in the process of updating the FAQs here. To assist us in enhancing these FAQs please send any comments or questions about the NCATS Prior Approval of Delayed Onset Research Involving Human Subjects to this email address. Additional resources and information can be found on the NCATS CTSA Program Consortium website here.

IMPLEMENTING THE PROJECT COLLABORATOR MODEL FOR PROGRAMMATIC MANAGEMENT OF UL1 CTSA AWARDS
What’s the change? NCATS is transitioning to the Project Collaborator model for programmatic management of UL1 CTSA Awards.

What does this mean to UL1 awardees? The extent of NCATS’ staff involvement will NOT change.  Instead of working with 2 different staff members (program officer AND project coordinator), PIs will work with a single program staff member, the project collaborator, who will fulfill both roles. The individual named in the NoA as the program officer will serve as the project collaborator and will be responsible for the same duties as the project coordinator and program officer.

Why is NCATS making this change? This approach promotes efficient communication and resolution of issues because it enables us to co-locate information streams within individuals to ensure appropriate, efficient, and seamless oversight, risk management and scientific advancement. Questions?  Please contact your Program Officer.

Questions?  Please contact your Program Officer.

SUMMARY OF LEAVE, PART-TIME AND EXTENSION POLICIES NOTICE OF LEAVE FOR NRSA

This notice clarifies policies on part-time training, leave (vacation, holiday, sick, parental, unpaid leave of absence), and requests for extensions of an award or appointments due to interruptions in training. For more information, please follow this link: NOT-OD-18-154.

CAREER AWARD (K) POLICY UPDATE

The purpose of this notice is to update NIH policy NOT-OD-08-065 concerning concurrent support from mentored career development (K) award and a research grant. For more information, please follow this link: NOT-OD-18-157.

MEETINGS & EVENTS

UPCOMING MEETINGS

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 the event form (login required) on the CLIC website.

Upcoming events are listed below. Please click the Event Name for more information!

Questions? Contact help@clic-ctsa.org

UPCOMING NCATS EVENTS

*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 Meeting 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 CTSA Program Communications page.

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