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Research Community News
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iRIS/OnCore Updates
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DOCR News
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Recruitment Innovation Corner
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Did You Know?
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Training Opportunities
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Clinical Research Employee Highlights
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Partner Resources
SUPPORT OFFICE HOURS
REDCap Office Hours
Email redcap-docr@duke.edu to schedule a virtual session at one of the times indicated below.
- Tuesdays 10 AM, virtual sessions
- Wednesdays 10 AM, virtual sessions
- Thursdays 2 PM, virtual sessions
- Fridays 10 AM, virtual sessions
SlicerDicer Office Hours
Thursdays, 2 PM, via WebEx
Click for SlicerDicer Tipsheets
PACE Office Hours
Every other Tuesday, 1 PM, via WebEx. Click for information.
RESEARCH COMMUNITY NEWS
Survey for DEPRU Lab Needs
The Duke Early Phase Clinical Research Unit (DEPRU) is a multidisciplinary clinic that specializes in the care of subjects enrolled in research studies. The subjects range from healthy volunteers to those with specific disease conditions who have volunteered to participate in a research study. It is located on the third floor in the red zone of Duke South. This unit consists of a confinement area, exam rooms, a satellite pharmacy, and a laboratory.
Lab services include processing & shipping of study samples as well as a COLA/CLIA accredited clinical research core laboratory offering hematology and chemistry testing. Turn around time for results can be as soon as 30 minutes. The hours of operation are generally Monday - Friday, 7:00 AM - 5:00 PM, but hours vary considerably based on the needs of the research protocol.
DEPRU is conducting a Lab Needs Survey in an effort to assess the lab needs of Duke Researchers. Results of this survey will be used to help DEPRU plan for the future of their lab.
Who Can Serve as PI? The Principal Investigator Qualifications Policy
As a reminder, the Principal Investigator Qualifications Policy on who can serve as PI on a study submitted to the DUHS IRB can be found on the IRB web site:
https://irb.duhs.duke.edu/policies-and-regulations/policies/principal-investigator-qualifications
Only regular rank faculty members can be placed in the PI or co-PI roles on a study submitted to the DUHS IRB. This applies to both non-exempt research, and research that has been declared exempt by the IRB from further IRB review. For the list of job codes that are required for a person serving in the role of PI or co-PI, please go to https://irb.duhs.duke.edu/irb-review-process/getting-started and click the tab that says "What Are the Eligibility Requirements for a Principal Investigator?” [See the Spreadsheet Showing the List of Job Codes that Are Required for a Person Serving in the Role of PI: the eligible job codes have the word YES next to them.]
Requests for exception to this requirement may be sent from the Departmental Chairperson directly to the DUHS IRB Executive Director.
It is the CRU’s responsibility to ensure that this policy is followed, and the IRB is requesting that CRUs provide this information to their faculty and staff, as part of ongoing training. If a CRU would like to obtain a regular report of all exempt studies belonging to their CRU, to monitor and audit this, contact the OASIS Reporting group for assistance.
Office of Export Controls
The Office of Export Controls (OEC) is a resource provided to help Duke University researchers and staff remain compliant with U.S. laws controlling the export (or disclosure) of both goods and technology and with sanctions upon certain foreign countries. Whether you are shipping research materials to another country, have questions about foreign visitors and sensitive information, or need help navigating prohibited activities for international projects, the Office of Export Controls is available to guide and assist.
Check out the OEC website for information regarding physical importing and exporting:
Additionally, the July 14th Research Wednesdays session will be dedicated to the topic of Export Controls, presented by Daniel Vick, Duke University Office of Export Controls.
Join the July 14 Research Wednesdays WebEx here: https://dukemed.webex.com/dukemed/j.php?MTID=mc0f3e0a565ef5e91e31cadc7c68a0d9f
Duke Health OutList
In the spirit of Pride Month in June, Duke is excited to announce and support the relaunch of the Duke Health OutList to help cultivate a more robust, connected and equitable community across health professions students, graduate students, post-docs, residents, staff and faculty.
The goal of OutList is to foster an open, affirming institutional culture and provide opportunities for support, connection and mentorship within our community.
The revitalized OutList will offer the following:
- Expanded scope – all learners, trainees, postdocs, staff and faculty across Duke Health are welcome and encouraged to participate
- Updated and improved mentorship process – mentors and mentees will be able to connect based on a variety of needs (professional development, shared research and clinical interests, shared identity – e.g., navigating healthcare with intersecting racial and LGBTQ+ identities)
- Opportunities – individuals will be able to highlight any special skillsets or training expertise in providing LGBTQ+ affirming care
- Internal provider referral directory – accessible by all Duke Health providers to facilitate referring patients to affirming providers who specialize in LGBTQ+ healthcare
To participate: https://duke.qualtrics.com/jfe/form/SV_dbzsafnx6LdTank
Research Blood Draws on Inpatients at Duke Hospital
Effective July 12, 2021, the Clinical Laboratory Phlebotomy Service will begin collecting inpatient Research blood orders on the following units:
There will no longer be a need to associate a standard of care lab in order to get these drawn.
As part of this new service, Clinical Laboratory Phlebotomy Service will charge the following fees to your project fund code:
- Piggyback blood draw on inpatient: $3.22
- Inpatient blood draw: $8.89
- COVID inpatient blood draw: $14.56
For a step by step process for the collection of both Research Only draws as well as Research draws with standard of care labs, refer to the Tip Sheet Process for Research Blood Draws on Inpatients at Duke Hospital
Call for Research Project for REACH Equity Center Renewal: Submissions Deadline August 9
https://sites.duke.edu/reachequity
The Duke Center for Research to Advance Healthcare Equity is seeking a research project and investigator to include in its renewal application (Spring of 2022). The Center currently supports three research projects related to the REACH Equity theme to address racial and ethnic disparities in health by developing and testing interventions that improve the quality of patient-centered care in the clinical encounter (https://sites.duke.edu/reachequity/).
The Center is inviting investigators to submit proposal ideas to include in the competing renewal application.
Full details, criteria, and required materials are available here
If you are interested, please review the full project and investigator criteria and submit your proposal (2-page max) and CV for consideration by August 9, 2021.
Submit materials to: Cheryl Miller, cheryl.j.miller@duke.edu
The PROMISE Study: NIH-funded research study to promote success and equity of underrepresented researchers in the biomedical workforce
Enrolling now! Group meetings start in August 2021!
Mentoring Study for Racially/Ethnically Underrepresented (UR) Researchers
Peer mentoring has been shown to support academic success. This randomized controlled study compares two peer group mentoring approaches for their positive impact on both personal gains (e.g., sense of belonging, research self-efficacy) and longer-term career outcomes (e.g., publications, grants submitted and funded, promotion). (DUHS IRB #Pro00103457).
Eligibility:
- Postdoc or Early-Career Faculty engaged in biomedical research (the investigation of the biological or behavioral processes that advance the diagnosis, treatment and/or prevention of disease)
- Identify as belonging to a racial/ethnic group underrepresented in biomedical research careers. (Black or African American, Hispanic or Latinx, South Asian, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, or Multiracial)
- US citizenship or Permanent Residency Status (Green Card)
Benefits:
- Peer group meetings facilitated by senior UR researchers discussing professional development for personal gains and skills-building to enhance academic productivity
- Compensation up to $500
Study participation involves:
- Enrollment session
- Group meetings (currently by Zoom) for 2 hours, twice per month, for 9 months.
- Completion of online surveys
Interested? Find out more about the study and register your interest on our website, or contact Rebecca Kameny, PhD rebecca.kameny@duke.edu (919) 668-3949; or Cam Hollister nsh10@duke.edu
IRIS/ONCORE UPDATES
Consent Category Requirement Improves iRIS to OnCore Documentation
In order for studies to process as expected, it is vital that information is submitted properly into the various systems. A crucial factor in the workflow of iRIS is that all consents are submitted with a consent category. This allows for proper processing in both iRIS, OnCore, eREG, etc.
The Consent form category is now a required field in iRIS. Per the new policy, Consent Category Requirements in iRIS and OnCore, when submitting a consent form in iRIS (initial, amendment or continuing review submission), the study team must ensure an appropriate consent category (e.g. Adult, Minor, eConsent, Spanish language, etc.) is applied, in addition to the consent form document name, version number and version date.
A consent category must be selected in iRIS to ensure all IRB submission approval details push into OnCore. When a consent form is submitted without a category type in iRIS, the associated review and approval details will not push into OnCore from iRIS resulting in inaccurate approval and consent information.
OnCore is the Institutional System for registering research participants. When registering a participant on a protocol in OnCore, the study team must select the correct consent version the participant signed to ensure appropriate documentation.
DOCR NEWS
July and August Phlebotomy Competency for Research Classes
Due to instructor availability, the July and August Phlebotomy Competency for Research classes have been rescheduled. See below for rescheduled dates and times along with registration links.
- Phlebotomy Competency for Research
- Friday, July 16, 2021, 1:00 to 3:00 P.M.
- Offering ID: 00161378
- Registration Link: https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000111962
- Phlebotomy Competency for Research
- Wednesday, August 18, 2021, 1:00 to 3:00 P.M.
- Offering ID: 00161379
- Registration Link: https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000111963
New Online Training Module – Strategies to Support Retention of Clinical Research Participants (Approx - 20min)
This new online module is now available in the LMS! This module was developed in collaboration with the RIC, DOCR, and CERI and takes about 20 minutes to complete. The purpose of this online module is to reviews the strategies clinical research teams can implement to support retention of clinical research participants. There are resources and tips shared within this module that will help clinical research personnel work through this critical part of their role.
The module addresses the following learning objectives:
- Define participant retention
- Describe strategies for retention and their importance
- Identify ways to set clear study expectations to support retention
- Discuss the importance of study continuation with participants
The content provides guidance to help develop the following WE-R clinical research competency: Participant Retention
You can also find this course on the DOCR WE-R Competency Training page under the Participant Retention competency.
Research Professionals Network: Building Your Portfolio for Tier Advancement: Writing Tips and Strategies
Friday, July 9th, 2021 at 2:00 on Zoom
Portfolio development is required for Tier 3 coordinator Tier Advancement and Tier 2 RPL Tier Advancement. The portfolios will undergo committee review from peers and leadership. This session will focus on strategies for building a successful portfolio for Tier Advancement and your professional career in clinical research. We will focus on how to ensure appropriate level of detail, highlighting your leadership experiences, and showcasing your accomplishments.
Speakers: Steven Shipes and Donna Crabtree
Join Zoom Meeting:
https://duke.zoom.us/j/98063534674?pwd=VGo0eWY0NnE1L2U5TU1MUWEreUtjUT09
Meeting ID: 980 6353 4674
Passcode: 577423
One tap mobile
+16468769923,,98063534674# US (New York)
+13017158592,,98063534674# US (Washington DC)
Learn more about the Research Professionals Network at docr.som.duke.edu
ClinicalTrials.gov Corner
Did you know every study that is *active in ClinicalTrials.gov must be verified at least once per year? Update the Record Verification Date to the current month and year every time you update the record, and at least annually otherwise. This helps keep the record compliant and lets the public know the study information is current.
*Verification is no longer necessary once all required results information has been submitted, or the overall status is updated to completed, terminated or withdrawn.
RECRUITMENT INNOVATION CORNER
Engagement, Recruitment, & Retention Certificate Program: Nomination Period Opens July 14th!
The CTSI Recruitment Innovation Center and DOCR would like to welcome managers to consider nominating employees for the upcoming cohort of the Engagement, Recruitment, and Retention Program.
The purpose of the program is to develop experts in these topics who can serve as a resource in clinical research units and divisions at Duke. Those who complete the program in its entirety will receive a Duke Recruitment, Engagement, and Retention certificate and are encouraged to use that certificate as a career development tool to enhance applications for Tier Advancement.
The curriculum also features:
- A diversity and inclusion lens throughout
- Expert instruction in timely and requested topics
- Engaging and thought-provoking material and interactions
- Wiki access for continuous resource sharing among the cohort
- Online pre-activities and in-class discussions
- CEU credit hours for SOCRA and ACRP certifications
The program consists of an online pre-requisite course, six core classes, and three electives. Participants will choose from seven elective options. Anyone participating in the program can anticipate approximately 18 hours of commitment associated with the program over a 6 month period. Participants can expect no more than two classes each month from September 2021 – March 2022. The tentative course sequence is available in the program flyer.
Managers are invited to nominate employees who perform participant engagement, recruitment and retention activities and whom they believe additional training would make them good resource in their units. If you are an employee who is interested in the program, please consult with your manager for nomination.
The nomination form will be open from July 14 to August 11.
Want more information? Check out the program website.
Please direct any questions to Jamie Roberts (Jamie.roberts@duke.edu) and Jessica Cranfill (Jessica.cranfill@duke.edu).
DID YOU KNOW?
REDCap: Re-evaluate ASI or Alerts & Notifications
Now you can re-evaluate some or all Automated Survey Invitations or Alerts & Notifications. If the conditions for ASIs or Alerts have been modified after data has already been entered in the project, users may click the “Re-evaluate Auto Invitations” button in the Online Designer or “Re-evaluate Alerts” button on the Alerts & Notifications page.
This will re-evaluate selected ASIs or Alerts for all records to ensure that invitations/notifications get properly sent or scheduled based on the new conditions. Note: RE-evaluating will *NOT* modify anything for already-scheduled invitations or alerts, such as text, recipient or sender addresses, and the date/time that the invitation is scheduled to be sent. Re-evaluating will schedule invitations/alerts that haven’t been scheduled that should be scheduled, and conversely, it will remove any invitations/alerts that are currently scheduled that should not be scheduled (because the condition no longer evaluates as TRUE).
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
Upcoming training offerings can be viewed by month on the DOCR Calendar.
Detailed information about each offering and direct links to the offering are also available on the DOCR website under Available DOCR Trainings.
CLINICAL RESEARCH EMPLOYEE HIGHLIGHTS
- The Department of Population Health Sciences welcomes Michelle Bean as a CRC – Research Registered Dietitian
- The Children’s CRU welcomes:
- Conrad Kubaney, CRNC, with the Marcus Center for Cellular Cures
- Leticia Flores, CRS Sr, with Pediatrics Medical Genetics
- Melissa Usoz, CRC, with Pediatrics Medical Genetics
- The School of Nursing CRU welcomes Allison “Ally” Johnson, CRC, who started in June
- The Department of Radiology CRU congratulates:
- Aalanah Valentine on her promotion to CRC in our CRU
- Kelly Valentine on her promotion to CRC in our CRU
PARTNER RESOURCES
DUHS Compliance Office
Catch up on news from the DUHS Compliance Office.
To be added or removed from the distribution list for the DOCR Clinical Research Update newsletter, please contact the DOCR at docr.help@dm.duke.edu