COMMUNICATIONS

CTSA PROGRAM UPDATE
January 12, 2018

CTSA PROGRAM

PI WEBINAR – TOWN HALL – WE WANT TO HEAR FROM YOU!

The January 24th (2 – 3 PM ET) PI webinar will feature a “town hall” format with Dr. Christopher P. Austin (NCATS Director) and Dr. Michael G. Kurilla (Division of Clinical Innovation Director). Dr. Kurilla joined NCATS on December 11th and is excited to meet many of you in the coming months. In preparation for this new format, NCATS would love to hear what topics or questions you would like to discuss during the town hall. You will also have the opportunity to ask questions live during the webinar.

Send us your questions by completing this form. The portal will close on Friday January 19th.

PROGRAM GUIDANCE

Human Subjects Prior Approval Checklist

The NCATS checklist for submitting Human Subjects research studies has been revised to indicate more clearly the documents that are needed for a complete prior approval request.

A companion document, providing visual highlights, of the most common omissions or areas of concerns based on cumulative experience with past prior approval submissions has been developed and will be shared with the submission community (pending final approval).

To be transparent, the institutional Authorized Organizational Representative (AOR) will be the most impacted, as they have historically been involved in submitting the packages to NCATS. We value your input and welcome your constructive feedback on the document that can be found here.

Please email NCATS CTSA Program or David Wilde; with your comments by COB January 26,2018.

Updated FAQs have been posted here: CTSA Program Prior Approval Frequently Asked Questions

Notice of Requirement for Electronic Submission of Research Supplements to Promote Diversity in Health-Related Research and Upcoming System Validation (NOT-OD-18-111)

To accurately track diversity supplements and diversity awardees, NIH is requiring that all applications for diversity supplements (both single and multi-project) must be submitted electronically as of January 25, 2018. Applicants can use ASSIST, institutional system-to-system (S2S), Grants.gov Workspace, or NIH’s streamlined system through eRA Commons for submitting administrative supplements.

Reminder and Updates for PAR-18-464: Clinical and Translational Science Award Funding Opportunity Announcement

The next receipt date for PAR-18-464 is February 2, 2018. The following notices were released to correct information in the funding opportunity:

• Notice of Correction for PAR-18-464 Clinical and Translational Science Award (U54 Clinical Trial Optional) (NOT-TR-18-012)

o Purpose is to provide correction regarding the “Eligible Organizations” as well as the “Number of Applications” an institution may submit to PAR-18-464 .

• Notice of Correction for PAR-18-464: Clinical and Translational Science Award (U54 Clinical Trial Optional) (NOT-TR-18-015)

o Informs the community of an application forms issue with PAR-18-464 .

Questions? Please refer to the funding opportunity announcement or the notices.

STEERING COMMITTEE UPDATES

NEW STEERING COMMITTEE (SC) MEMBERS

After thoughtful deliberation, NCATS is pleased to announce the following UL1 Principal Investigators who will serve three-year terms on the CTSA Program SC: Barry Coller (Rockefeller University), Brad Evanoff (Washington University at St. Louis) and Phil Kern (Kentucky).

NCATS would like to thank outgoing SC members Bob Clark (University of Texas Health Science Center), Sundeep Khosla (Mayo Clinic), and Harry Shamoon (Einstein-Montefiore) for their service.
NCATS intends to rotate through the consortium so that over time all PIs will have the opportunity to be on the Steering Committee.

A full list of CTSA Program SC members can be found here.

STEERING COMMITTEE TO HOST EXECUTIVE SESSION CALLS

In discussions held over the last three months, the SC has concluded that it could and should play a more active role in “steering” the consortium. In order to fulfill this role, the SC will begin to hold executive sessions to candidly identify and implement opportunities to accomplish our shared goals as a consortium.

In addition, the SC seeks to strengthen the critical flow of information among NCATS, the SC, and the hubs so that there are multiple, transparent communication sources for the PI group and the entire consortium. This will be accomplished in the following ways:

• CLIC will post meeting summaries from the SC calls onto the CLIC-CTSA Program website and continue to circulate monthly CTSA Program newsletters with important project-level updates and consortium activities
• The SC is revisiting the pod structure to encourage streamlined and productive bi-directional information sharing, keeping in mind that this format can provide a robust opportunity for PIs to give feedback, make suggestions and share issues with the SC and NCATS leadership. A brief questionnaire will be disseminated by CLIC to the PIs to gather your individual thoughts on the utility and effectiveness of the pods. Please keep your eye out for that email!
• A subgroup of the SC is working with CLIC to devise a comprehensive multi-modal communications plan with both synchronous and asynchronous communication elements
• NCATS leadership will further engage the consortium by proactively providing additional information that may impact the Program. Further, NCATS will continue to work collaboratively with CLIC on disseminating salient updates on monthly PI calls and in other forums. If you have any questions, comments or concerns, PIs may contact their Program Officer or any person in NCATS leadership at any time.
• The CTSA Program Principal Investigator (PI) call (held on the 4th Wednesday of the month from 2- 3 PM ET) will continue to be open to all UL1, TL1, KL2 PIs, and Administrators who are interested in joining the calls and will feature presentations that are informative and thought-provoking for our community

FEEDBACK ABOUT PODS

The CTSA Program Steering Committee (SC) is gathering data on the effectiveness of the pods as a mechanism for communication of SC activities. The pods were created to facilitate bidirectional communication among members of our large and distributed network, ensuring that all CTSA Program PIs would be informed of discussion points and action items from executive session SC calls, and conversely that all PIs would have a mechanism to raise issues for the SC to consider.

However, like everything we do, the pod structure was an experiment, and may not be the most efficient or effective mechanism of communication (and now in 2018, certainly not the most technologically savvy!). Among other issues, there is considerable variability in the way the pods function; leading to potential differences in the information various PIs receive. We’ve heard your concerns and feedback in anecdotal form, and in order to determine what changes to make, if any, we need more systematic data collected.

After the data is gathered, CLIC will post de-identified aggregate results from this questionnaire onto the CLIC website. No direct quotes nor any information that may identify a specific Hub will be posted. Further, CLIC will act as an honest broker and will not provide NCATS with any identifiable information from the survey. Results will be posted on the CLIC website soon!

UPDATED PODS

Assignments to the CTSA Program pods have been updated to reflect the new SC membership, and each pod has been notified of the changes. While the SC deliberates changes to the pod structure, pods are requested to continue as status quo until a final determination is made. A full list of pods can be found on the CLIC website.

COMMON METRICS

WELCOME NEW COMMON METRICS INITIATIVE LEAD

Beginning January 10, 2018, Patricia Jones will be leading the NCATS Common Metrics Initiative. Her new role will include directing the process for developing, demonstrating, and disseminating metrics throughout the CTSA Program Consortium. The Common Metrics Initiative facilitates Hubs strategically managing clinical and translational research activities, strengthening research translation and workforce development and ultimately, improving the public’s health through the CTSA Program Consortium collecting information on a set of shared metrics.

Read more here.

COMMON METRICS PAGE ON CLIC WEBSITE

We invite you to visit the CLIC Common Metrics page where we maintain current and past information and training and metric materials.

INFORMATICS COMMON METRICS PILOT UPDATE

The last pilot call occurred on January 9 and sites will report their informatics data and finalize their Turn-the Curve (TTC) plan, entering them into Scorecard by the end of January. As part of the pilot close-out work, the CLIC team will conduct an evaluation of the pilot through a survey and interviews with pilot sites to assess the utility and feasibility of the metric, which will help define recommendations and next steps. The results of this will be posted on CLIC website.

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

DOMAIN TASKFORCE (DTF) UPDATE

CLIC WEBSITE REGISTRATION

You MUST REGISTER on the CLIC website to access DTF/WG meeting materials. Please contact your DTF/WG CLIC Coordinator, Liaison, or the CLIC helpdesk if you require assistance.

INFORMATICS DOMAIN TASKFORCE

The iDTF Lead Team election has been completed – two new members have been voted on to the Lead Team. GQ Zhang is chief of the Biomedical Informatics Division in the University of Kentucky College of Medicine and co-director of the Biomedical Informatics Core of the Center for Clinical and Translational Science. Albert Lai is Chief Research Information Officer for the Institute for Informatics and an Associate Professor of General Medical Sciences at Washington University School of Medicine in St. Louis.

March 16, 2018 – iDTF Face-to-Face Annual Spring Meeting – in San Francisco – 7:00am to 1:00pm PST – directly following the Spring AMIA Summit. More information to come!

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

METHODS AND PROCESSES DOMAIN TASKFORCE

Methods & Processes Domain Task Force welcomes Willard H. Dere, from the University of Utah, to the Lead Team. Dr. Dere has been a professor of internal medicine in the Division of Endocrinology and Metabolism at the University of Utah for the past 3 years. He splits his time between the University’s large genetics program and serving as the Executive Director of the Program in Personalized Health and Co-Director of the Utah Center for Clinical and Translational Science.

Institutional Readiness for Team Science Working Group: The working group is collaborating with the Collaboration & Engagement DTF and the Clinical and Translational Science Institute at Children’s National (CTSI-CN) on the Great CTSA Team Science contest. Five sub-committees have been established and are soliciting volunteers from the other working groups.

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

WORKFORCE DEVELOPMENT DOMAIN TASKFORCE

There were eight IGNITE projects presented in the January meting. An IGNITE project is an idea to address the challenge of refining and disseminating education and training innovations with other CTSA Hubs. We requested DTF members to submit ideas that highlight and share one educational resource or approach that has been particularly impactful at their local hubs. Those locally developed innovative education resources that have been demonstrated to have both local value and sustainability are considered for dissemination with other Hubs or even the entire consortium. Here are six of the eight IGNITE projects that were presented to the membership, their contact info if you are interested in collaborating and more information for each project.

• CTSA Educational Innovation (Columbia) – Sophia Li Ferry
• CTSI 500 Stars Initiative (CTSI of SE-Wisconsin) – Doriel Ward
• Virtual World Video Game to Teach Team Science Skills (UCSD) – Colin Depp
• Lilly Making Medicines: The Process of Drug Development online course (Indiana/Eli Lily) – Patricia McGuire
• KL2 Scholar Exchange Program (Indiana and University of Kentucky) – Patricia McGuire
• Enhancing Clinical Translational Research through Training in Digital Practices and Approaches (USC) – Katja Reuter and Cecilia Pacino-Sutton

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

ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK

ACT NETWORK LAUNCHES AT FIRST 21 SITES

The ACT Network, an NCATS CTSA Program-funded, real-time, open access platform allowing researchers to explore and validate feasibility for clinical studies, is launching this month at 21 sites across the CTSA Program consortium.

The ACT Network was developed collaboratively by members of the CTSA Program consortium to help clinical investigators explore and validate feasibility for clinical studies using electronic health record data. Using ACT, investigators can:

• Explore patient populations in depth, in real time, from the desktop.
• Confirm study feasibility by iteratively testing and refining inclusion and exclusion criteria.
• Demonstrate feasibility in funding proposals and IRB submissions.
• Identify potential partners for multi-site studies by searching for patients across the CTSA network.

ACT is secure, HIPAA-compliant and IRB-approved, and is available to all researchers at participating sites. ACT will formally launch at the first group of 21 CTSA’s during the first quarter of 2018, with support from the ACT dissemination team. An additional 13 CTSA’s are now completing technical staging to join ACT later this year, bringing ACT’s reach to nearly 60% of the CTSA Program consortium by the end of 2018.

Because ACT was built by CTSA’s, for CTSA’s, our workgroups are structured to keep CTSA needs and input front and center, and include representation from over 15 CTSA member institutions. We will also gather ongoing user feedback from our CTSA partners and ACT users. This feedback will allow a process of continuous improvement for the benefit of clinical researchers throughout the CTSA Program consortium. Please feel free to reach out directly to the ACT Network PI group with questions, suggestions or feedback:

Steve Reis; Lee Nadler
Gary Firestein; Bob Toto

Look for our national website to launch later this month!

CTSA PROGRAM DATA TO HEALTH COORDINATING CENTER (CD2H)

CD2H WEBSITE RELEASE

The CTSA Program Data to Health Coordinating Center is delighted to announce the release of the CD2H website! The site is available at https://ctsa.ncats.nih.gov/cd2h and provides a conduit for the CTSA community to access CD2H resources and content, collaborate and exchange ideas with the translational informatics community through working groups and events, and promote and disseminate their own resources and initiatives.

The CD2H wants to hear from you! Learn more about working groups, sign up for the CD2H listserv, or contact the CD2H team directlyby filling out the web form . You can also follow the conversation on Twitter at @data2health.

OPPORTUNITIES

REMINDER: NEW NIBIB-CTSA TRAINING PARTNERSHIP – APPLICATIONS DUE JANUARY 23, 2018

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)

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

ANNOUNCEMENTS

CTSA PROGRAM MEETINGSPRING

The Spring CTSA Program Meeting will be held April 18 – 19, 2018 at the Marriott Wardman Park, 2660 Woodley Rd NW Washington, DC 20008

Tentative Agenda:

*Times subject to change

Additional details including the registration and hotel reservation links will be available in mid-February. Updates will be provided on CLIC’s website here.

SPRING MEETINGS ON CLIC WEBSITE

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 a meeting or event please fill the event form (login required) on the CLIC website.

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

Questions? Contact help@clic-ctsa.org

*To add the Town Hall 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.