Duke Clinical Research Update

Wednesday, September 4, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Research Community News
iRIS/OnCore Updates
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


Slicer Dicer Office Hours

Thursdays | 1 pm | Erwin Square Room 1022 | via WebEx

REDCap Office Hours

Tuesdays | 10 am | DUMC Library 212C Seeley G. Mudd Bldg
Thursdays | 2 pm | via WebEx
Fridays | 10 am | Erwin Square Room 1022
 


Research Community News

 

A New Study Closeout Policy Effective September 1st

A New Study Close Out policy went into effect September 1st.

Highlights of the new policy include:

  • You no longer need to submit a Service Now ticket to close an RSH record in Maestro Care or remove a Fund Code. 
  • Each month, DOCR will review all protocols that closed with the IRB. If the following criteria are met, the RSH will be completed:
    • The protocol status in OnCore is IRB Study Closure
    • All participants have an inactive status in Maestro Care and OnCore
    • The RSH005 is clear of all charges.
  • Fund Codes will remain in the RSH record to allow for reporting.  You still need to submit a ticket if you are changing project fund codes.  

For additional information, view the August 28th Research Wednesdays recording of Reviewing Closeout Processes Across Systems with Catee Mullen, Dalia Mack, Susan Natoli and Kristy Astin.

 

Just-In-Time Notifications on Federal Government Awards

The DUHS IRB has posted information regarding Just-In-Time Notifications on Federal Government Awards to their website.  If you anticipate receiving a federal government award, please visit this page on the IRB website.

 

UPDATE to Prompt Reporting/Unanticipated Problems Policy

The IRB’s policy on Prompt Reporting was revised to eliminate inconsistent messaging about which safety events and protocol deviations must be reported to the IRB.  Please review the updated policy:  https://irb.duhs.duke.edu/policies-and-regulations/policies/unanticipated-problems .

Note in particular the following:

A Protocol Deviation/Violation must be reported to the IRB if it:

  1. affects subject rights and welfare; or
  2. affects subject safety; or
  3. affects the integrity of study data; or
  4. affects the subject's willingness to continue in the study; or
  5. is specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB.

Over-enrollment of study participants (i.e., exceeding the target enrollment) does not require the submission of a protocol deviation to the IRB but does require an amendment to increase enrollment.

The reporting timelines for when events must be reported to the IRB have not changed, and the reporting timelines can be found in the updated policy.

If you have questions, please contact the IRB Specialist for your CRU:  https://irb.duhs.duke.edu/about-us/staff-and-chairs .

 

+DS Offers 8 In-Person Learning Experiences for September

The +DS in-person opportunities dive deeper into the basics of data science across multiple important application domains. These learning experiences are developed to target diverse units at Duke: from those that desire a broad understanding of what is possible with data science, those who wish to use data-science tools (software) without a need for deep understanding of underlying methodology, and those who desire a rigorous technical proficiency of the details and methodology of data science.

The +DS In-Person Learning Experiences for September are: 

  • September 3: Introduction to Neural Networks (David Carlson); waitlist only
  • September 5: Convolutional Neural Networks (Tim Dunn)
  • September 9: Natural Language Processing with Neural Networks (Larry Carin); waitlist only
  • September 11: TensorFlow (Kevin Liang)
  • September 17: Introduction to Reinforcement Learning (Larry Carin)
  • September 18: Humanities +DS and Social Sciences +DS: Text Generation with GPT-2 (Matthew Kenney)
  • September 19: Generative Adversarial Networks (Ricardo Henao)
  • September 24: Overview of Ethical Issues with Emerging AI (Nita Farahany)

Anyone in the Duke community is welcome to join, and no prior experience is necessary. Register for IPLEs on the +DS website: https://plus.datascience.duke.edu/learn-ds#iple

 

Save the Date:  Duke Clinical Research Appreciation for Faculty and Staff

The annual Duke Clinical Research Appreciation Event for Faculty and Staff, “Navigating Your Path to Success”, co-sponsored by the School of Medicine and the Clinical Translational Science Institute is scheduled to take place Thursday, October 10th from 11:00 AM – 1:00 PM in the Trent Semans Center Great Hall and Atrium.  This drop in event is a celebration of the great work taking place in Clinical Research at Duke.  Mark your calendars now and stay tuned for additional details as the event approaches.

 


iRIS/OnCore Updates

 

Minimum Footprint – Retrospective Studies Tip Sheet Updated

The Minimum Footprint-Retrospective Studies tip sheet has been updated to address the Summary Accrual Info Only field. 

Please leave the Summary Accrual Info Only field blank or select NO for retrospective studies.  Do not select YES.  Although the IRB asks for the number of charts reviewed in the annual report, charts reviewed are not counted as accrual. 

 

Adding a New Fellow to an iRIS Application?

Are you trying to add a new fellow or team member to the Key Personnel list in an iRIS application?

If you are unable to find a particular name in the system, this means that the person has not logged into the iRIS system for the first time.  Contact the person you would like to add to the study and ask them to log into the iRIS system using their Duke Net ID and password.

This will pull their name into available study personnel and will also map their CITI training to their account.

In order to add someone as key personnel on a study, they must be up to date on their CITI training.  The iRIS system has an interface with the CITI training system.  If you ARE able to find a person’s name in the iRIS system and are unable to add them to your protocol due to a Training Validation error, follow these step:

  1. Check that the person is up to date on their CITI modules.
  2. If the person is up to date on their CITI modules and you are unable to add them to your protocol due to a Training Validation error, submit a Service Now Support Ticket to have the person’s completed CITI training manually mapped into the iRIS system.

 

Accessing iRIS Support

There is a new way to access iRIS Support. Click on the Help button, and then click the first link in the Help pop up. The link will display a support request form to complete that bypasses the Service Desk, and delivers your support ticket directly to the organization that can assist with your specific issue (ORI, DOCR or the Duke Health IRB team).  The help button also takes you to additional resources, forms and tip sheets to help with your work.

 

Need Help with OnCore?

You can now email OnCore@duke.edu directly to create a Service Now ticket.  One-on-one assistance is provided to anyone who contacts our team.  Often times, we are able to screen share via jabber or web-x to aid in the resolution of more complicated issues. 

Please don’t hesitate to contact us- we offer timely resolutions to your OnCore questions and concerns.  If you would like to request one-on-one assistance or training for your team, please email Kristy Astin and Susan Natoli.


DOCR News

 

Institutional Regulatory Policies and Procedures in Clinical Research Management Online Course Now Available

A new online course, Institutional Regulatory Policies and Procedures, is now available to the Duke Community in the Learning Management System (LMS).  Course information including a direct link to the LMS course is shown below.

Course Title:  Institutional Regulatory Policies and Procedures in Clinical Research Management

Course Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=dowbt000000000039885

Course Description:  This course will provide Duke employees engaged in clinical research with information about regulations, guidelines, and policies for conducting clinical research at Duke University.

Learning Objectives: 

  • Find and follow applicable standards, guidelines, regulations, policies and procedures for performing clinical research at Duke
  • Identify and interpret policies and regulations regarding Duke Health IRB oversight of research 
  • Describe study elements that must be approved by or reported to the Duke Health IRB             
  • Identify research approval elements and responsible offices at Duke

Competency(ies):  Institutional Regulatory Policies and Procedures (IRPP)

 


Did You Know?

 

REDCap Online Designer

REDCap’s online designer has an option to copy existing choices.  You may choose from one of existing sets of choices from other multiple choice fields in the project.  Click the 'Use' button next to each to import that set of choices into the current field's Choices text box.


Training Opportunities

 

Upcoming DOCR Training Offerings

DOCR training offerings are available in the Duke LMS. There are 2 easy ways to find all DOCR classes: Enter “DOCR” in the search field and click Search, or click the Category link, and then click the DOCR link. The results display all the offerings currently available from DOCR. Hint: If you want to bookmark the Duke LMS in your browser, edit the bookmark to this address: https://lms.duhs.duke.edu/Saba/Web/Cloud

Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.


Clinical Research Employee Highlights

  • The Duke Human Vaccine Institute (DHVI) CRU would like to congratulate Luis Ballon, CRC, on his CCRP certification.
  • The DHVI CRU welcomes Jodi McDonald as a Clinical Research Specialist, Sr. and Darren Morrow as a Clinical Research Coordinator.
  • The Department of Medicine CRU welcomes the following new staff:
    • Pooja Kothari joined Division of Gastroenterology as a CRC
    • Emily Hecker will be joining Geriatrics as CRNC September 16th
    • Michael Dagher joined ID as Research Scholar
    • Celia Kohler joined ID as CRS, Sr.
  • The Psychiatry CRU welcomed Rachel Orr, MHA, CCRP, as the Assistant Research Practice Manager starting August 12th

Partner Resources

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

To be added or removed from the distribution list for the Duke Clinical Research Update, please contact DOCR at docr.help@dm.duke.edu.