Support Office Hours
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
Slicer Dicer Office Hours
Thursdays | 1 pm | Erwin Square Room 1022 | via WebEx
PACE Office Hours
Office of Regulatory Affairs and Quality (ORAQ) Implements Changes
Starting November 1, 2019, the Office of Regulatory Affairs and Quality (ORAQ) will implement several changes that will impact institutional regulatory support at Duke University. At the request of the School of Medicine (SOM), ORAQ will implement the following changes with goals to improve the quality of regulatory submissions, increase efficiency and reduce delays with regulatory approvals, and decrease risk by ensuring compliance with federal regulations:
- Regulatory Review Requirements: All regulatory submissions associated with a clinical trial must be reviewed by ORAQ prior to submission to the U.S. Food and Drug Administration (FDA). The new requirements will be phased in over time and will start with reviews of initial applications.
- Costs for ORAQ Support: In order to sustain and expand resources, ORAQ will begin charging for regulatory support. ORAQ effort that is not already supported by a department or grant will be charged back to academic research departments.
- New Submission Processes: Any drug or biologic submissions sent to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for research INDs will be submitted electronically through FDA’s Electronic Submissions Gateway (ESG) in non-eCTD format.
These changes were communicated by SOM leadership to Department Chairs in August and were subsequently shared with Clinical Research Unit (CRU) Directors and Research Practice Managers (RPM) in September.
For additional information, please see our frequently asked questions on the new regulatory review requirements, ORAQ costs, and submission processes. If you can’t find the answers to your questions here, please reach out to us at ORAQ@duke.edu.
Best Practices for the Preparation, Submission, and Maintenance of Sponsor-Investigator INDs and IDEs
The Office of Regulatory Affairs and Quality will be hosting the following workshops during the month of November:
- The Investigational New Drug (IND) Workshop, November 19th, 9:00 AM – Noon, Hock Plaza Auditorium
- The Investigational Device Exemption (IDE) Workshop, November 20th, 9:00 AM – Noon, Hock Plaza Auditorium
For information about the workshops and to register: https://medschool.duke.edu/research/research-support-offices/office-regulatory-affairs-and-quality/educational-seminars
Introducing the New Psychiatry Research Intranet
The Psychiatry Clinical Research Unit is thrilled to announce that the new psychiatry research intranet is now live!
Developed by the Clinical Research Unit (CRU) team in partnership with the Grants Administration and Research Finance teams, the research intranet is a one-stop shop for Psychiatry research resources, designed to meet the needs of research, grants administration, and research finance needs of the Psychiatry researchers.
You can access the research intranet in four ways:
- bit.ly/PsychResearchIntranet – You’ll need to log in with your NetID.
- MyResearchHome – In the “My Links” widget, search for “Psychiatry Research Intranet” under all links. Once populated, click on the star it to save it to your Favorites.
- Duke Psychiatry website “Research” page – Link is at the bottom of the page.
- DOCR CRU website “CRUs and OOs” page – Scroll to “Psychiatry” to find the link to the website.
CTSA Program Diversity and Re-Entry Research Supplements to UL1 Awards
The CTSA Program is committed to improving the diversity of the workforce and to supporting re-entry into active research careers for those individuals that have taken an eligible hiatus from research. We would like to take this opportunity to highlight some of our outstanding program awardees who have used the supplement to advance their careers and fulfill their research objectives. As a reminder, the CTSA Program supports Diversity and Re-Entry Research Supplements to active and eligible UL1 grants through the following funding opportunity announcements (FOAs):
PA-18-906: Research Supplements to Promote Diversity in Health-Related Research
PA-18-592: Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers
Please follow this link https://ncats.nih.gov/ctsa/profiles for NCATS specific guidance as well as for questions/answers. Applications are due November 1.
NCATS POC: Xinzhi Zhang, M.D., Ph.D.
Duke Clinical Research Appreciation Day a Success!
Thanks to the research community for making the Duke Clinical Research Appreciation Day a success! Research community members enjoyed food, music, and information tables. Guests were also treated to a visit from Vice Dean for Clinical Research Dr. Adrian Hernandez.
Thanks also to all of the event’s table representatives who populated myRESEARCHpath! Stay tuned for more information regarding the myRESEARCHpath initiative in the months to come.
What’s New in OnCore?
- The New Study Minimum Footprint tips sheet has been divided into separate Oncology Library and Non-Oncology Library documents. They are available now on the OnCore Support page.
- Definition Revision: After receiving additional clarification from Forte, the definition for Protocol Target Accrual field has been changed to “the total for the study, all sites included”. You do not need to revise previous entries.
- In order to track studies where Duke is a site for a DCRI coordinated study, linking information should be added to the PC Console>Main>Management tab for the Duke as a site study. Select YES for DCRI Participation. Include the IRB number for the coordinating center protocol if known.
Accessing the iRIS Application
Did you know that in order to access the iRIS application all that is required of end users is a Duke Net ID and password? There is no special access request or training required.
If you are trying to add someone’s name to a Key Study Personnel list and do not see their name as a pick option, this means that the person has not logged into the iRIS system with their Net ID and password for the first time. Ask the person to log in to the iRIS system. This will populate their name on the iRIS KSP pick list and will also link their CITI modules to their iRIS profile.
Do you need to add someone to your study as a collaborator, statistician, etc.? This type of personnel access request is accomplished through a KSP Change Request Form (not through Service Now). You will need to submit a KSP Change Request in order to add someone to a study in any study role other than that of the study PI/Co-PI.
For detailed instructions on the DUHS IRB Key Study Personnel (KSP) Change Form, see the iRIS Tip Sheets on the DOCR website.
Research Professionals Network: A Growth Mindset and Mentorship
Join the Research Professionals Network on Thursday October 24th, 1:00 PM in Trent Semans Great Hall for a session A Growth Mindset and Mentorship.
During this session, Steve Shipes will discuss the benefits of developing a “growth mindset” and the importance of having a mentor.
Growth mindsets are essential to our ever changing work environment. Individuals who have growth mindsets have been found to have greater comfort with taking personal risks, strive to achieve their stretch goals, higher motivation, and enhanced competencies across wider ranges of responsibilities. They also have lower stress anxiety and depression levels, better work relationships, and higher performance levels.
Supporting a dynamic workforce with mentors, who have varied backgrounds and experiences, is crucial when nurturing a growth mindset that focuses on talent management.
Light refreshments will be provided. Please use this link to register.
Learn more about the Research Professionals Network at docr.som.duke.edu.
Welcome to the Recruitment Innovation Corner!
The Recruitment Innovation Center is part of the Clinical and Translational Science Institute (CTSI). We are here to help you with your recruitment needs (for FREE). We offer several services, including:
- Tailored recruitment consultations (from grant planning to urgent needs)
- Review and editing of patient facing materials such as flyers, consent forms, websites, screening surveys, social media, MyChart Invitations, etc.
- Plain Language mini-consults
- Patient Advisory Councils and patient engagement studios
If you would like to request a consult or one of our services, please complete a request form and we will be in contact within 1 business day.
We also have a library of tools, tricks, and tips to improve recruitment and retention to your studies!
Tip of the Week:
Did you know that about 30% of people in the US have difficulty understanding basic health information?* The University of Michigan offers a Plain Language Medical Dictionary that can help you make your patient-facing material (flyers, consents, brochures, etc.) more lay-friendly and readable for potential participants.
For example: turn the word protocol into study plan, approximately into about, or intramuscular into a shot in the muscle.
*America's Health Literacy: Why We Need Accessible Health Information. An Issue Brief From the U.S. Department of Health and Human Services. 2008
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.
- Congratulations to Ellen Parker, MSN, RN, CRNC, Sr for the Thoracic Oncology team for passing the OCN exam.
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 email@example.com.