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CTSA PROGRAM UPDATE
August 10, 2018
CTSA PROGRAM UPDATES
 
SAVE THE DATE – FALL CTSA PROGRAM MEETING
The 2018 Fall CTSA Program Meeting is taking place on October 22 – 23. The Full Day Fall CTSA Program Meeting is October 23 only. Location details and a tentative agenda are below:

Arlington, VA 22202
2399 Jefferson Davis Highway
Hilton Crystal City at Washington Regan National Airport

MONDAY, OCTOBER 22
 
Time TBD Steering Committee Meeting
12:00 – 5:00 p.m. Administrators Meeting
5:00 p.m. – 7:00 p.m. Networking Reception & Mini-Poster Session*

TUESDAY, OCTOBER 23
 
Full Day (Time TBD) Fall CTSA Program Meeting
Morning Session
  • Update from NCATS
  • Report from SC DTF Task Force
  • Presentation from SMARTIRB/ ACT
Networking Opportunities
  • 30 minute breaks – Morning & Afternoon
  • Longer Lunch – Meal Provided
Afternoon Session
  • Open Solicitation from consortium of topics for best practices
Additional details, including the registration and hotel reservation links, will be available soon.

*New this Year! – Networking Reception & Mini-Poster session

The Fall CTSA Program Meeting will begin with a Networking Reception & Mini-Poster Session on Monday, October 22. Each hub will have the opportunity to share a poster highlighting 1-2 innovative ideas or projects being worked on at their hub. Additional details will be shared on the August PI Call (August 22 at 2:00 p.m. ET) and on the CLIC website when available
CONTINUE SUBMITTING CTSA PROGRAM WOW! FACTOR STORY SUBMISSIONS 
We have received several WOW! Factor Stories. Please continue submitting those and highlight key accomplishments from your hubs. Selected information from the submission may be further developed into future NCATS communications. Your CTSA Program Officer may contact you for additional information.
 
As before, hubs can still submit ‘Consortium News’ stories via the CLIC website. These are ‘everyday’ news stories/hub updates to be highlighted as a summary blurb on the CLIC site (linking back to the original article) and potentially promoted on the CLIC Twitter.
 
If you have a story that you’d like to share with NCATS, and you’d also like to feature it on the CLIC website, please submit both submission forms. You can access both forms by logging into the CLIC website and heading to the News page.


Questions?  Contact Clare Schmitt
ADMINISTRATORS GROUP
Quarterly Calls: We are very pleased to bring back quarterly webinars/calls of the CTSA Program Administrators group starting this September. They will be held the last month of each quarter on the 3rd Wednesday from 1:00 – 2:00 p.m. ET beginning on September 19. Here is the registration link.

The CTSA Program Administrators’ Face-to-Face Meeting is scheduled for October 22, prior to the 2018 CTSA Program Fall Meeting. Details:
  • Monday, October 22
  • 12:00 – 5:00 p.m. ET
  • Hilton Crystal City at Washington Reagan National Airport, Arlington VA 22202
  • Registration will be available by the end of August
We have confirmed volunteers to help us plan the meeting and will soon be sending out a survey asking for topics for our sessions. More details are forthcoming, and a draft agenda from NCATS/CLIC can be found on the CLIC site.
CLIC UPDATES
 
UPCOMING REQUEST FOR APPLICATIONS – COLLABORATIVE FUNDING OPPORTUNITIES
Synergy Papers
 
The goal of cross-hub multi-disciplinary translational science “synergy” papers is to advance the field of translational science and build collaborations within and external to the CTSA Program consortium, while meeting the academic needs of co-authors to produce high quality scientific publications. In addition, the process of working on a joint manuscript forges new relationships and teams around shared goals, develops a common vocabulary across translational stages, and serves as a springboard for further collaborations.
 
In the coming weeks, CLIC will invite collaborative teams to apply and propose topics for a synergy paper that focuses on either:
  1. A significant translational science process or method roadblock and how to address this challenge to advance translational science; or
  2. A content/knowledge review of a pressing translational science topic across several stages of the translational continuum, identifying gaps and approaches to move the field forward (that would also include a section on relevant process gaps as well). 
 
Selected synergy paper teams will receive one year of administrative support to develop a manuscript and submit their manuscript to a scientific journal for publication.
 
More details on the application process will be shared as they become available. Please email CLIC with any questions.

Un-Meetings
 
An Un-Meeting is an event without the rules and structure of a traditional conference. Attendees create and drive the agenda and discussions, based on a common theme. This format provides a unique approach for attendees to discuss their experiences and identify areas of potential research, innovation, and collaboration, with the ultimate goal of developing multidisciplinary, collaborative partnerships.
 
In June 2018, CLIC hosted a consortium-wide Un-Meeting at the University of Rochester, which brought together over 100 researchers, clinicians and public health professionals to discuss how to best address the opioid crisis through translational science and research. Attendees from more than 40 institutions, agencies and companies from across the country discussed a variety of opioid-related topics, forged new partnerships and collaborations, and developed ideas to tackle the crisis.
 
This recap video shares highlights from CLIC’s first Un-Meeting, and further information and resources from the event can be found here. Additionally, this brief video from the University of Montana provides a nice overview of the overarching Un-Meeting concept, which is an event without the rules and structure of a traditional conference.
 
In the coming weeks, CLIC will invite CTSA Program hubs interested in hosting their own Un-Meeting on a topic of their choice to submit applications. The selected applicant will receive funds to support the meeting, along with planning guidance and materials from CLIC.
 
More details on the application process will be shared as they become available. Please email CLIC with any questions.
CLIC NEWS ROUNDUP
CLIC has received requests from CTSA Program communicators and administrators to be regularly kept up-to-date on what's going on around the consortium, and to be able to easily share that content. In response, CLIC has created a bi-monthly news roundup, which shares news updates from CLIC, from CTSA Program hubs and from 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
 
ARRIVAL: HUB-SPECIFIC REPORT ON 2016 COMMON METRICS DATA 
The CLIC Common Metrics Team was pleased to send out the 2016 Common Metrics Initiative Hub reports to hub PIs, Administrators, and Evaluators! Hubs will receive a feedback survey during the month of September, so there is time for your Common Metrics Teams to discuss the report as well as potential opportunities for using the data internally, and in potential collaborations with other hubs.

REMINDER: 2017 COMMON METRICS DATA SUBMISSION
The LAST DAY for entering your 2017 Common Metrics data update and Turn the Curve (TTC) plans is Thursday, August 30, 2018! Please refer to the TTC Entry Guidance, sent to hubs on July 20, 2018 for information on how to archive previous TTC plans in Scorecard. The TTC Entry Guidance is also available on the Common Metrics page of the CLIC website. As always, email our Common Metrics team if you need assistance.

INFORMATICS METRIC UPDATE
Watch your e-mail for the Informatics Team Formation Guide! Following the Informatics Common Metric (ICM) pilot, hubs indicated it would be helpful to have guidance on forming and engaging an ICM team prior to the consortium-wide implementation of the Informatics Metric. The CLIC Common Metrics Team has developed this resource and is releasing it to hubs to assist with team formation prior to the September 2018 roll-out of the Informatics Metric. The Team Formation Guide will also be posted on the Common Metrics page of the CLIC website.

To facilitate the metric implementation process, the CLIC Common Metrics Team will be contacting hubs in early August to determine which data model (PCORnet, OMOP, i2b2/ACT, i2b2/TriNetX, or other i2b2 data model) your hub intends to use for ICM. Details on these models will be forthcoming in the email communication.

As part of our continued communications to the consortium on Common Metrics, our team will present results of the ICM pilot as well as on the consortium-wide metric implementation plan at the August 22 PI Call. Join the call to hear more! Register for the CTSA Program PI Webinar here.
FREE TRAINING AVAILABLE: CLEAR IMPACT SCORECARD SOFTWARE 
Clear Impact is offering CTSA Program hubs free access to the Clear Impact Scorecard certification training. Visit this link to register for the course. Enter code: CTSA1 to complete registration.

Please contact both Lauren@clearimpact.com and Marcais@clearimpact.com with course questions.
DOMAIN TASK FORCE (DTF) UPDATES
 
THE GREAT CTSA TEAM SCIENCE CONTEST
Team Science has been identified as a critical element of the CTSA Program. The Great CTSA Team Science Contest is an opportunity to share your team science experiences (successful or not) with your CTSA Program colleagues. The contest is open to anyone associated with your hub (investigators, community members, staff, etc.).
 
Submit your story here.
 
Additional information about the contest is available after you click the link. Stories may be submitted from now until September 10. Winners will be highlighted at the national CTSA Program meeting in October (see more info here).
 
There is no limit to the number of submissions from a CTSA Program hub.
 
The contest is endorsed by the CTSA Program Steering Committee and organized by the Institutional Readiness for Team Science Work Group of the Methods & Processes DTF. Background slide deck and notes are deposited on the CLIC website here.

INFORMATICS DTF
The Informatics DTF (iDTF) Lead Team developed a plan for both the iDTF and CD2H to develop and oversee workgroups under various umbrellas. These CTSA Program workgroups are open to everyone. The iDTF meetings will serve as the venue for all CTSA Program informatics workgroups to provide status updates. 

A schedule of these updates are as follows:
CLIC – CTSA Informatics Members Meetings iDTF Topic(s) CD2H Topic(s)
August 3 Common Metrics Presentation (20 min) / Lifespan (20 min) CD2H Update (15 min)
September 7 Election time frame announcement + (15 min) CD2H Software WG Show & Tell & F2F Report Out (45 min)
October 5 EasiPro Presentation / Election Process description / + (45 min) CD2H Update (15 min)
November 2 Election timeframe reminder / + (15 min) CD2H People WG Show & Tell & F2F Report Out (45 min)
December 7 Election Announcement / + (45 min) CD2H Update (15 min)
January 4 TBD (15 min) CD2H Data WG Show & Tell (45 min)
 
Additional Updates:

In response to the discussion report-outs from the iDTF face-to-face meeting held in March, three workgroups have developed and are in the process of having their charter drafts reviewed and approved by the iDTF Lead Team, then moving onto the iDTF membership for the same. These workgroups include: 
  • Secondary Models
  • Text Analytics and De-Identification
  • Sustainability – Phase Two
 
The iDTF Lead Team, including members of CD2H, worked to develop a policy covering non-CTSA Program presentations made to the iDTF membership. The policy and guidelines are as follows:
  • In order for an external body to present to iDTF:
    • The presentation must be of broad interest to the members
    • The content must have significant potential impact on achieving key NCATS goals
    • The presentations must be educational and not designed to promote commercial interests or products
    • The presenter must declare any potential “conflicts of interest” via a slide included in the presentation
    • The slides must be provided to iDTF Leadership for review to confirm compliance with the above criteria
 
The Sustainability Informatics Infrastructure publication is still being revised – they are waiting for input from the co-authors. Their current deadline is mid-August for completion.
UPDATES FROM OTHER CTSA PROGRAM INITIATIVES
 
ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK
The ACT Network now has three sites that have officially launched to local end users – University of Minnesota, Duke University, and University of Pittsburgh. Others are slated to launch throughout the summer and fall. 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

SMART IRB
Harmonizing approaches to single IRB review
 
Two newly-harmonized resources are now available to support the implementation of single IRB review:
 
The Institutional Profile captures institutional, local, and state requirements that a Reviewing IRB may need to apply to its review and oversight of studies on behalf of another institution, as well as information about an institution's IRB(s), if applicable.
 
The Protocol-specific Document allows a Reviewing IRB to collect variations across participating sites regarding key information about study teams (e.g., training and conflicts of interests) and variations in study conduct (e.g., ancillary reviews required; HIPAA requirements; subject population).
 
These documents were developed and approved by SMART IRB’s Harmonization Steering Committee and its working groups following consideration of public review and comment. Check out SMART IRB’s Resource Library for these, and other tools, templates, and checklists for Reviewing IRBs, Relying Institutions, and study teams.
 
SMART IRB’s Online Reliance System: Request, track, and document reliance arrangements
 
Watch how SMART IRB’s Online Reliance System helps the more than 440 SMART IRB Participating Institutions (and their investigators) coordinate study-specific reliance arrangements when using the SMART IRB Agreement:
The Online Reliance System’s guided workflow:
  • Simplifies the selection of a single IRB for multisite studies
  • Manages communication between institutions and investigators
  • Tracks the status of requests
  • Clearly indicates what needs to be done next
  • Documents reliance arrangements for each study
Reminder options help keep the process moving, and sites can be added to a reliance arrangement via an amendment process. On-demand reports are available to provide institutions a summary picture of their requests and registered users.
 
Learn more about the Online Reliance System. If your institution is not yet registered, contact SMART IRB to request access. Once registered, your investigators can start using the system to document reliance arrangements for their studies.

TRIAL INNOVATION NETWORK (TIN)
Have you missed any of our Collaboration Webinars? You can access all of our past webinar recordings and materials under the Archives tab on the Network Events page.

We are seeking CTSA Program experts to share methods and/or best practices to improve the way trials are conducted for our Collaboration Webinar series. Interested in presenting? Submit your webinar idea here.

The TIN continues to accept investigator proposals for multi-center clinical trials and studies. Visit our website to learn more about the proposal process, see upcoming webinars, and search our Recruitment & Retention toolkit.

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

Questions?  Contact Mary Stroud

IRB RELIANCE EXCHANGE (IREx)
IREx Reaches More than 200 Institutions and Over 1400 Users
 
The IREx continues to grow in use:
  • 95% of CSTA Program institutions have joined (view all members);
  • 1400+ users have access, including IRBs/HRPPs, study PIs and coordinators, and coordinating centers;
  • 70 studies and nearly 300 reliances are in IREx, including all 37 active TIN CIRB studies.
IREx provides a web-based platform used for single IRB documentation, approvals, and communication from initial study start up through the life of the study (protocol amendments, annual reviews, etc.)  
  • Is your institution or IRB looking for cost-conscious resources to support single IRB review?
  • Are you a study team or coordinating center applying for a grant and in need of single IRB resources?
IREx can help! Learn how by requesting a live demo tailored to your group here.
 
Visit our website.
Contact us via email.

RECRUITMENT INNOVATION CENTER (RIC)
RIC Recruitment and Retention Plan Template
 
The RIC, with support and assistance from several external partners, is developing a recruitment and retention plan template designed to assist research teams in meeting NIH requirements for applications with budgets greater than $500,000. The template been created with multiple stakeholder input and is currently under review with support from recruitment and retention experts across the larger CTSA Program community. We anticipate the template to be finalized in the next several months. The RIC will utilize the template as part of TIN consultations and service delivery. Additionally, we will make the resource shareable and openly available to anyone through the Recruitment and Retention Toolkit on the TIN Website.

Questions?  Contact Mary Stroud

NATIONAL CENTER FOR DATA TO HEALTH (CD2H)
CD2H Presentation at the PI meeting on July 25
 
Learn more about the CD2H’s approach to accelerating informatics innovation. Watch the video recording and download the slide deck from the CD2H update during the July CTSA Program PI meeting. You will also see details on three of the projects that are currently underway. CD2H looks forward to further engagement with the community and as always, welcomes your feedback and suggestions.
 
Sign Up for a First Look at CD2H News
 
Sign up now for the inaugural CD2H monthly newsletter to be delivered in the coming days. Stay up to date with the latest developments from CD2H as we work to support and accelerate collaboration and innovation across the CTSA Program informatics ecosystem. Follow the latest from CD2H on Twitter at @data2health.
 
Register for Upcoming CD2H Events
 
Please join us for our CD2H Community Workgroup meetings this fall. Your input and feedback are critical for informing CD2H's work. We are eager to learn from your expertise and to explore how CD2H can best meet your needs and we look forward to collaborating with you. Please stay tuned for detailed information about the meeting agenda and how to prepare for the meeting.
Questions?  Contact Sarah Biber
NATIONAL EVALUATORS GROUP 

The Survey Workgroup has begun analysis of the 61 responses received to the Evaluators Survey. The Evaluation Guidelines workgroup has begun analysis of the data and narrative responses related to the sources of advice for evaluation and the questions regarding NCATS evaluation policy.

CLIC is analyzing the responses to the question regarding the impact the Common Metrics Initiative has had on local hub programs and evaluation practices. The Evaluator Survey Workgroup is analyzing the evaluation challenges and examples of evaluation impact responses as well as the responses to questions on evaluation resources and tools at CTSA Program hubs.

We will work with the National Evaluators Group to schedule several presentations of our findings by survey section (management and methods section, common metrics section, guidelines section) starting in the Fall 2018; after which we anticipate completing a white paper report of findings for internal distribution.

Questions?  Contact Bill Trochim

ANNOUNCEMENTS
 
DELAYED ENFORCEMENT AND SHORT-TERM FLEXIBILITIES FOR SOME REQUIREMENTS AFFECTING PROSPECTIVE BASIC SCIENCE STUDIES INVOLVING HUMAN PARTICIPANTS

The purpose of this notice is to describe interim policy flexibilities for a subset of NIH-funded studies whose primary purpose is the pursuit of basic science. These are studies that meet the NIH definition of a “clinical trial” and that also meet the Federal definition of basic science. 
 
Notice Number: NOT-OD-18-212
 
For more information, please view the full notice.

2019 CONTRACT SOLICITATION FUNDING OPPORTUNITY NOW AVAILABLE

NCATS invites small businesses to apply for funding through the 2019 Small Business Innovation Research (SBIR) contract to support small businesses interested in developing innovative health technologies.
 
The deadline for submitting proposals is Oct. 22, 2018, 5:00 p.m. ET.

NCATS’ contract funding topics for 2019 include: 

  • Synthetic Technologies for Advancement of Research and Therapeutics (START)
  • Universal Medium/Blood Mimetic for Use in Integrated Organs-on-Chips 
  • Non-PDMS Biocompatible Alternatives for Organs-on-Chips
Important Dates:
  • Aug. 16, 2018: Contract Funding Webinar (Register today!)
  • Aug. 31, 2018: Q&A Deadline
  • Oct. 22, 2018: Solicitation Deadline

For more information, please view the solicitation. For questions on NCATS SBIR contract topics, please contact NCATS Contracting Officer Jeffrey Schmidt at jeffrey.schmidt@nih.gov.

Questions?  Contact Tiina Urv, PhD.

DEVELOPMENT OF MEDICATIONS TO PREVENT AND TREAT OPIOID USE DISORDERS AND OVERDOSE (UG3/UH3)
The purpose of this Funding Opportunity Announcement is to support the discovery and development of medications to prevent and treat opioid use disorders (OUD) and overdose.

Under the Help to End Addiction Long-term (HEAL) Initiative, NIDA has been allocated funds to support medications development to prevent and treat opioid use disorders and overdose. NIDA is currently accepting grant applications for up to $3 million dollars per year (or more with prior NIDA approval) for up to five years under the RFA DA-19-002. This RFA is designed to review and fund grant application in an expedited fashion with a rolling acceptance of applications and expedited review by NIDA Council.


FOA Number: RFA-DA-19-002

Questions?  Contact Dr. Iván Montoya

RARE DISEASES CLINICAL RESEARCH NETWORK (RDCRN) & DATA MANAGEMENT AND COORDINATING CENTER (DMCC) 

The Office of Rare Diseases Research at NCATS, in partnership with NCI, NIAMS, NIAID, NIDDK, NICHD, NINDS, NIDCR and NHLBI announced two funding opportunities to support collaborative clinical research on rare diseases through the Rare Diseases Clinical Research Consortia (RDCRC) and a Data Management and Coordinating Center (DMCC); both funding opportunities have a deadline of October 9, 2018.
 
The purpose of the RDCRN is to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness. Each RDCRC will promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs.
 
The DMCC will facilitate and support the activities of each Rare Diseases Clinical Research Consortium (RDCRC) along with trans-network activities that broadly facilitate the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research and; 4) Engagement and Dissemination.
 
FOA Number RDCRN: RFA-TR-18-020
FOA Number DMCC: RFA-TR-18-021
 
Questions?  Contact Tiina Urv, PhD.

CHANGE IN RECEIPT DATE FOR DIVERSITY AND RE-ENTRY SUPPLEMENTS

Applications may be submitted at any time up to November 1 each calendar year for consideration for funding in the current fiscal year, which always ends on September 30. Applications received after November 1 will be processed and considered for funding in the following fiscal year. Applications will be evaluated, and decisions will be made within two to three months of receipt, but funding decisions can be influenced and delayed by other factors, including the availability of funds. Therefore, potential applicants are advised to consult first with the NCATS program official (PO) assigned to the linked grant and with the relevant NCATS scientific contact prior to submission of a request for a supplement application.

For more information Click Here

Questions?  Contact Erica Rosemond, PhD

COLLABORATIVE INNOVATION AWARDS (CCIAs)

Next CCIAs’ due dates are: November 9, 2018 for the U01 PAR-18-244 and November 29, 2018 for the R21 PAR-18-245. Please click on PAR links for more information.

Questions?  Contact Erica Rosemond, PhD

NIBIB SUPPLEMENTS TO NCATS CTSA PROGRAMS TO SUPPORT NIBIB TRANSLATIONAL RESEARCH SCHOLARS 

The purpose of this administrative supplement is to facilitate translational research partnerships between junior researchers with quantitative backgrounds (in engineering or computational or physical sciences) and junior clinician-scientists from active CTSA Program institutions (PAR-15-304, PAR-18-464).
 
FOA Number:  PA-18-851
 
Questions?  Contact Zeynep Erim, Ph.D.

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 Meeting Webinar Registration**

*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 CLIC Newsletters page or on the CTSA Program Communications page.

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