NUCATS Minutes

This fall more than 700 people attended the Biostatistics Collaboration Center's Fall Lecture Series. Slide decks and recordings from all presentations are available in DigitalHub and on the BCC website.

The Final Rule requirements for registering and submitting summary results information to ClinicalTrials.gov went into effect on September 16, 2016. The ClinicalTrials.gov PRS system for submitting studies will be ready to support submission requirements by January 18, 2017. Researchers will then have 90 days from that date to comply.

Under the Final Rule, studies must be registered to ClinicalTrials.gov within 21 days of enrolling the first trial participant and results must be reported within 12 months of the date of final data collection. Non-compliance can result in fines of more than $11,000 per day for the PI and a stoppage of all federal funding to the institution until compliance is restored. FDA and NIH will be auditing and enforcing these rules.

NUCATS can help with ClinicalTrials.gov reporting. If you have any questions or need assistance complying with these updated requirements, please contact the NUCATS Regulatory Team at Clinicaltrials.gov@northwestern.edu.

For additional information, see the attached New England Journal of Medicine article.

Northwestern Memorial HealthCare has implemented a new research fee schedule. Click here to learn more.

To update your budget to include the updated fee schedule, sign into Study Tracker. (Please note: you must be on VPN or the NU network to log in)

All faculty, from experienced to novice mentors, are invited to attend Mentor Development Workshop on December 8 from 1-5pm. Topics discussed will include: maintaining effective communication, establishing expectations, and promoting professional development.

Click here to register.

NUCATS is accepting applications for pilot awards. These awards of up to $10,000 address the small gaps in clinical and translational research that are not funded by other sources.

Applications are due November 30.

For more information and to apply click here.

Apply for funding from the N.XT fund to support early stage innovations that are too advanced for federal funding but too early for private investment. Individual awards will range from $50,000 to $200,000.

Applications are due December 1. Click here to apply.

Discover best practices in sex-inclusive research from national experts who are leading the way in sex-inclusive research during the Sex Inclusion in Biomedical Research Workshop and Symposium.

The event will be held from 12 to 6pm on January 25 at Prentice Women's Hospital.

Click here to submit an abstract by December 20.

Click here to register.

Has NUCATS helped you in your research? Then please take a moment to help NUCATS by sharing how your research has benefited from our services. NUCATS is partially funded by an NIH grant and must demonstrate its impact on clinical and translational research. These stories are one of the most effective ways to do so.

Share your story

All investigators, co-investigators and study personnel listed on an IRB application for a clinical trial must complete Good Clinical Practice Training by January 1, 2017.

Get more information or register for a course.

 

INVO is hosting a free seminar, Venture Capital 201: The Science (and Art) of the Investment on Nov. 10 at 4:00pm, which will discuss pitch decks, investment memos, term sheets and more.

 

Click here to register.

The Biostatistics Collaboration Center is hosting a lecture series on Tuesdays and Fridays during the month of October. The first talk, Four Lessons in Biostatistics and Some Biostatistics Along the Way, will be presented by Leah Welty, PhD, Director of the Biostatistics Collaboration Center on Friday, October 7 in Hughes Auditorium from noon to 1 pm.

Click here for a full list of presentations and to register.

Click here to livestream the presentation.

Are you a new Northwestern faculty member, or just looking for resources and services to support your research? NUCATS supports investigators and study teams across the full spectrum of clinical and translational science research. Learn more about the resources and services offered by NUCATS on our newly launched New Faculty Onboarding page.

 

Are you a new Northwestern faculty member, or just looking for resources and services to support your research? NUCATS supports investigators and study teams across the full spectrum of clinical and translational science research. Learn more about the resources and services offered by NUCATS on our newly launched New Faculty Onboarding page.

If you are considering conducting research in primary care practices, Center for Community Health (CCH) and its practice-based research networks can help you. CCH can introduce you to clinician partners, identify ways to implement your research in practice settings and focus your research to optimally addresses clinician needs.

Contact CCH-consultations@northwestern.edu for more information.

 

Registration is available for the upcoming Responsible Conduct of Research (RCR) series. Classes will be held from 3:30 - 5 pm on Tuesdays from Sept. 20 through Dec. 6. Postdoctoral fellows and junior faculty who have received NIH training awards are required to complete the series, which provides an overview of the principles and expectations of conducting research ethically and responsibly.

Access the fall syllabus here.

Click here to register.

Patient Centered Outcomes Research Institute (PCORI) has released several new funding opportunities.

Investigators interested in applying for the grants can receive assistance with grant writing, study design, patient and stakeholder engagement strategies and as well as letters of support from the Center for Community Health (CCH).

All investigators interested in applying should contact CCH and Center for Patient Centered Outcomes early on in the application and LOI submission process.

Learn more at: www.pcori.org/funding-opportunities?qt-funding_opportunities=1#qt-funding_opportunities&utm_source=081016+BOG%2C+Funding+Center+opening&utm_campaign=080216&utm_medium=email

Want to learn more about who's citing your work, your h-index, and the journals with the highest impact in your field? Sign up for Galter Library's Scopus and Web of Science classes this September. Scopus and Web of Science are citation databases that go beyond PubMed and can help you assess your research impact.

Sign up here: galter.northwestern.edu/classes

The Center for Community Health can help investigators and research teams idenitfy and establish collaborations with community and clinical partners as well as other stakeholders that will contribute to the design and implementation of their research aims.

To learn more, request a consultation with CCH: https://redcap.nubic.northwestern.edu/redcap/surveys/?s=LNELHR7YW7.

The DigitalHub repository now supports deposit of datasets associated with publications to help investigators comply with journal data sharing policies. DigitalHub supports a variety of compression formats and rights statements to meet your needs. Learn more at digitalhub.northwestern.edu/news or contact DigitalHub support directly at DigitalHub@northwestern.edu.

You are receiving this email because of your research activity at Northwestern University. To unsubscribe please click here.

Are you trying to disseminate research findings into the community?  The Alliance for Chicagoland Communities (ARCC) in the Center for Community Health has developed dissemination and communication tools including project website examples, tips for writing about community engaged-research in academic journals and non-academic settings and more.

To access these resources, visit: http://arccresources.net/category/dissemination-communication-tools/

NUCATS Center for Clinical Research (CCR) Financial Services Department is hosting a presentation on budget development for industry sponsored clinical trials on Tuesday, September 13 from 2- 3:30. The presentation will discuss the process of developing a study budget as well as the different parts of the budget.

To register, contact Kelsey Richey at kelsey.richey@northwestern.edu

 

The Center for Community Health (hyperlink to CCH consultation page- http://www.feinberg.northwestern.edu/sites/cch/funding/consulting.html) offers consultations to investigators and research teams to assist with community/patient/stakeholder engagement, project or proposal design/review/support, dissemination of findings to community audiences, etc.

 

To request a consultation, complete this form:  https://redcap.nubic.northwestern.edu/redcap/surveys/?s=LNELHR7YW7 

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University is an NCI funded center, and as such is required to abide by NCI rules related to research oversight. A particularly important requirement is the establishment of a protocol review and monitoring system, which within the Lurie Cancer Center is the Scientific Review Committee (SRC). The SRC is responsible for the review of all cancer relevant research conducted within the institutions that comprise the center. In particular, the SRC is responsible for review of:

  • the scientific merit of all new cancer relevant protocols,
  • prioritization of these studies, and
  • ongoing progress monitoring of the clinical protocol research of the center.

 

The SRC does not duplicate traditional peer-review (e.g., peer-reviewed protocols supported by the various NIH mechanisms). Protocols approved by these or other NCI approved external peer-review committees are reviewed administratively for prioritization, and accrual is monitored during ongoing progress review.

In order to comply with NCI requirements it is required that all cancer relevant research be submitted to the Lurie Cancer Center SRC prior to IRB submission. Such submission is required for all cancer relevant protocols. More information regarding SRC can be found online at cancer.northwestern.edu/ROS/index.cfm.

To help explain the role sex should play during research on various conditions, the Women’s Health Research Institute has developed a series of videos during discussing sex-inclusive medicine in the areas of cardiology, depression, dermatology and more.

Click here to watch.  

Departments and individual investigators who are working on lengthy projects requiring many hours of support from Biostatistical Collaboration Center (BCC) faculty or analysts can now retain these individuals for a set amount of time through a new subscription service offered by the BCC. 

Click here to contact the BCC for more information.

To help explain the role sex should play during research on various conditions, the Women’s Health Research Institute has developed a series of videos during discussing sex-inclusive medicine in the areas of cardiology, depression, dermatology and more.

To watch, visit https://www.womenshealth.northwestern.edu/why-sex-matters-research.   

 

The Robert H. Lurie Comprehensive Cancer Center of Northwestern University is an NCI funded center, and as such is required to abide by NCI rules related to research oversight. A particularly important requirement is the establishment of a protocol review and monitoring system, which within the Lurie Cancer Center is the Scientific Review Committee (SRC). The SRC is responsible for the review of all cancer relevant research conducted within the institutions that comprise the center. In particular, the SRC is responsible for review of:

  • the scientific merit of all new cancer relevant protocols,
  • prioritization of these studies, and
  • ongoing progress monitoring of the clinical protocol research of the center.

The SRC does not duplicate traditional peer-review (e.g., peer-reviewed protocols supported by the various NIH mechanisms). Protocols approved by these or other NCI approved external peer-review committees are reviewed administratively for prioritization, and accrual is monitored during ongoing progress review.

In order to comply with NCI requirements it is required that all cancer relevant research be submitted to the Lurie Cancer Center SRC prior to IRB submission. Such submission is required for all cancer relevant protocols.  More information regarding SRC can be found online at http://cancer.northwestern.edu/ROS/index.cfm.

 

Before submitting your next grant application, check out the new requirements for NIH grant applications. The requirements include the addition scientific premise, scientific rigor, consideration of relevant biological variables and authentication of key biological and/or chemical resources to all grant applications.

Click here to learn more. 

Are you trying to recruit women into a research study? Considering using Women’s Health Research Institute’s Illinois Women’s Healthy Registry which contains health information for 7,000 women interested in participating in research.

Click here for more information.

Do you have an idea for a new research study?

Quickly determine its feasibility with i2b2. This web-based tool allows you to run queries against a subset of data in the Northwestern Medicine Enterprise Data Warehouse. Variables which can be searched include the number of patients that have been diagnosed with a disease, had a procedure, meet certain demographic criteria, had a laboratory result and were prescribed a medication.

Click here to learn more.  

Each month, Galter Health Sciences Library provides training on various research tools. During the month of June, the library will teach one hour classes on EndNote and PubMed

 Click here to see the complete list of classes offered. Classes are available at their scheduled times as well as by request for individuals or groups.  

Do you have an idea for a new research study?

Quickly determine its feasibility with i2b2. This web-based tool allows you to run queries against a subset of data in the Northwestern Medicine Enterprise Data Warehouse. Variables which can be searched include the number of patients that have been diagnosed with a disease, had a procedure, meet certain demographic criteria, had a laboratory result and were prescribed a medication.

Click here to learn more.  

Improve your knowledge of research methods, processes, epidemiology and biostatistics by receiving a Master of Science in Clinical Investigation (MSCI). The MSCI program offers residents, fellows and junior faculty who are interested in pursuing a career in research the opportunity to receive formal research training and to apply this knowledge to their own research.

This part-time program is offered in the evening at Northwestern’s Chicago campus and can be completed in approximately two years. Applications are accepted on a rolling basis. The deadline for the Fall quarter is July 5, 2016. For more information, contact Adam White, program administrator. 

The First Monday Faculty Development Seminar Series is a monthly lecture for postdoctoral fellows and early career faculty. The sessions are structured to include tools and resources for navigating the research enterprise as well as strategies for building a successful research career.

Click here to learn more and to register for an upcoming seminar.

Learn about the application of data science and big data methods to clinical and biomedical research at Biomedical Data Science Research Day on Friday, June 10 from 7:30 am – 5:00 pm at Robert H. Lurie Medical Research Building.

During the event, faculty will discuss: 

  • Big data applications in genomics
  • Text mining in biological research
  • Real time data application in biomedicine
  • and more…

There is no cost to attend. Space is limited. Click here to register.

To assist in with the implementation of the new NIH policy requiring sex to be included as a variable in all grant submissions, Northwestern University’s Women’s Health Research Institute has created many helpful resources.

This includes a document describing how sex should be considered when it comes to experimental planning and statistical analyses. This helpful guide includes an explanation of five different scenarios, a table that can be used for a quick reference as well as questions to ask in order to accurately account for sex in research.

Click here to access this helpful resource.

For more information, contact the Women’s Health Research Institute.

Join Rebecca Williams, Pharm.D., MPH, Assistant Director of Clinical Trials.gov at the National Library of Medicine at the National Institutes of Health, as she speaks on “Academic medical centers and clinical research transparency” at the EQuATR Conference on May 11 at Northwestern Memorial Hospital.

Dr. Williams is currently responsible for the results submission process, outreach and education, policy development, and research related to improving reporting of clinical research at ClinicalTrials.gov.

During the plenary session, Dr. Williams will discuss:

  1. U.S. requirements for registering and reporting results of clinical trials
  2. The challenges academic medical centers face in meeting the U.S. requirements
  3. Ways to address these challenges at academic medical centers

The EQuATR conference, which is presented by NUCATS in collaboration with the ACRP Chicagoland Chapter, will also include a plenary session with Dr. Manu Vora, Chairman & President, Business Excellence, Inc., USA, a global quality management service firm. He will discuss “Performance Excellence in HealthCare.”

To see the full agenda, click here.

Today, Wednesday, April 27, is the last day to register. Click here to register.

 

Northwestern University faculty members have access to the Northwestern Medicine Enterprise Data Warehouse (NMEDW), one of the largest academic data warehouses, which contains health data on more than 8.3 million individuals.

Here are five ways to use the NMEDW to enhance research:

  1. Feasibility studies: Do you have an idea for a future study but are wondering if there is a large enough population to make it feasible? Or are you curious about a health condition within a given population? Use i2b2, a free web-based tool, that allows individuals to run queries against NMEDW data in order to determine the feasibility of a study.
  2. Analyze data: If you're trying to find information about unique health data points, hire an analyst to help you perform queries to better understand this data.
  3. Receive a pilot voucher: Early career investigators who do not have funding to hire an analyst to help them obtain feasibility or early pilot data can apply for a pilot voucher through NUCATS.
  4. Become a Poweruser: Have access to the NMEDW by participating in extensive database training.
  5. Quickly translate your research to patient care: The NMEDW is a shared platform providing analytics support for clinical research and healthcare operations. This reduces the time it takes for new discoveries to impact patient care.

Start using the NMEDW today.