Duke Clinical Research Update May 5, 2021
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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
Research Operations and COVID-19
The following memo was sent April 23rd from Duke’s Office of Research indicating that there have been no changes in our policies requiring masking, six feet physical distancing, and the use of SymMon.
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To: Duke University Research Community
From: R. Sanders Williams, MD, Vice President for Research & Innovation
Date: April 23, 2021
Re: Research operations and COVID-19
Thanks to all for your patience and resolve through a year of extraordinary challenges to our research effort at Duke. Although we look forward to the prospect later this year of relaxing restrictions and increasing the level of activity in our research facilities, at present the ongoing pandemic threat requires us to continue to limit the density of individuals in Duke facilities and to maintain our public health measures and monitoring practices.
Therefore, until further notice, research facilities must continue to operate at a density that allows for six feet of physical distancing between personnel. Masks continue to be mandatory in indoor shared spaces and outdoor settings where social distancing cannot be maintained. Daily symptom monitoring using the SymMon app remains a requirement to participate in activities in Duke facilities, and surveillance testing will continue through April 30th and resume May 10th for students, postdocs, faculty, and staff. Safety within our research spaces remains our highest priority, and these precautions are in agreement with restrictions in effect at many of our peer institutions.
We will navigate through this challenge as a strong and vibrant research community, and for now you can best advance that cause by remaining diligent in your safety practices, even if you’ve been vaccinated. If you have not yet received a COVID-19 vaccination, I strongly encourage you to schedule an appointment soon.
Virtual Recording Request Workflow
The Virtual Recording Request Workflow was developed over a year ago to eliminate the need for study teams to submit IRB amendments requesting a change in platform to Zoom or WebEx due to COVID restrictions. Moving forward, the REDCap link will be deactivated as this process is no longer needed. New study submissions to the IRB, that are recording participants, should include details specific to the recording platform being used. Study teams should continue to record LOCALLY to Duke owned/managed devices and utilize application security controls for all meetings.
Please click on the link below for instructions on recording a Zoom meeting.
For information on disabling chat, locking the meeting, or other features for added security with Zoom, please visit the following link: https://oit.duke.edu/help/articles/zoom-meetings-security-and-privacy-your-meetings.
Please click on the link below for instructions on recording Cisco WebEx Meeting.
https://help.webex.com/en-us/n62735y/Record-a-Cisco-Webex-Meeting
Updates from the Duke University Libraries Research Data Working Group
Data Sharing and Equity at DGHI
In a conversation with the Duke Research Data Curation team, Sabrina McCutchan of the Duke Global Health Institute’s (DGHI) Research Design and Analysis Core (RDAC) shares her thoughts on why data sharing and access is critical to global health research. Questions of equity must be addressed when discussing research data and scholarship on a global scale. Equitable practices paired with data sharing create opportunities for greater discovery and progress in research. Read the blog post here.
Curation for Data Reuse and Reproducibility
Data curation enables the reuse of data, the reproducibility of science, and further innovation. Curation can be multifaceted and can include organizing, formatting, and describing data, as well as making determinations for the ethical treatment for human subjects data (i.e., PII, PHI). The Duke Research Data Repository partners with Duke researchers as they actively prepare their data for sharing. To help researchers get started we have created a new checklist of things to consider. Contact us at datamanagement@duke.edu with any data curation or sharing questions.
IRIS/ONCORE UPDATES
OnCore: Subject Reconsent Tip Sheet
As discussed during the April 28th Research Wednesday, the tip sheet about how to use reconsent triggers in OnCore is available.
https://duke.box.com/s/zvlupumy8ghta2sp8tnnjr007ez8dwwu
Reminder: Save the OnCore Tip sheet folder as a favorite directly in Box.
- Click on this link: https://duke.box.com/s/km9qph94ya0v9qfb0u5ml4ir6ni2qimg to access the folder in Duke Box
- Click on the star in the pathway to set it as a favorite
Favorites are listed on the left hand side when you open Box.
New Non-Oncology Disease Categories in OnCore
We have added two new disease categories to OnCore.
- Remote Studies – for studies that are largely remote/virtual participation, requiring one or fewer in-person visits (for instance a study that is entirely remote but requires one in-person lab visit)
- Vaccine Studies – we think this is self-explanatory
Remember, the disease categories you select will help people searching the Duke Health Clinical Trials Directory find your study by filtering by the categories. You may select as many categories as you feel are appropriate. The RIC will review your category selections during the SIP review process.
Questions? Reach out to studyrecruitment@Duke.edu.
OnCore Study Information Portal (SIP) Content Tips and Worksheet Updated
The OnCore Study Information Portal (SIP) Content Tips and Worksheet has been updated.
The updated template can be found here:
https://duke.app.box.com/s/si4mbmwo6agm2360kh96qcgtzu68of5a
Updates include the following addition:
If your study is industry funded, please ensure any necessary sponsor approvals of the content have been obtained prior to sending your first draft to the RIC. The RIC review will not alter the meaning of the SIP content, just the format and lay-friendliness of the language.
DOCR NEWS
Tier Advancement 2021 Proctored Testing
Proctored testing for the November 2021 Tier Advancement cycle will be completed remotely through Duke Testing Center. Candidates must make an appointment for testing by calling (919) 684-1601 anytime during weekday business hours (8:30a-5p). When you sign up for a testing session, you will receive an Outlook invitation containing the Zoom link for your appointment. Tier Advancement candidates who have four or more required tests can choose to split up their tests among multiple sessions. For example, if you need to take 6 exams you can choose to take 4 tests in one session and take the other 2 in a different session.
The window for registering for a proctored testing session is June 7th through July 16th.
Additional details and information can be found within the Welcome Packet. If you have any questions, please contact the DOCR WE-R team at wer-jobs@dm.duke.edu.
RECRUITMENT INNOVATION CORNER
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT) Guidance Document: Diversity and Inclusion
The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT) has recently put out guidance document about Diversity and Inclusion in clinical research. This Guidance Document aims to clarify the importance of diversity and inclusion in clinical research and to provide practical and actionable ways to improve diverse representation of participants in clinical research1.
The guidance document is a comprehensive framework, grounded in a clear set of ethical principles. It provides an understanding of the goals of diversity, addresses current barriers to progress, and explores solutions to common scientific and sociocultural barriers to meaningful diversity in clinical trials.
In addition to the guidance document, they have provided a companion toolkit that includes practical resources to improve diverse representation of participants in clinical research. These resources include items like:
- Logic Models to help you conceptualize activities to promote diverse inclusion within a particular clinical research domain (i.e., workforce development, site selection, etc.)
- Diverse Participant Engagement Strategies Checklist
- Awareness Raising Initiatives to Promote Diverse Participant Engagement: a model checklist for implementers
- Accountability Key Performance Indicators
- Feasibility Questionnaire Modification Checklist
- and much more!
These resources were released by the MRCT in January 2021, but will continue to be refined as the MRCT continues to explore and expose changes needed to achieve diversity, inclusion and equity in clinical research.
As always, please Contact us for any of your research needs! We can help you develop engaging eConsents, MyChart messages, websites, engagement letters, research notices, and more!
Follow us on Facebook at Discover Duke Research.
1 https://mrctcenter.org/diversity-in-clinical-research/guidance/guidance-document/
*Guidance Document citation: Bierer B.E., White S.A., Meloney L.G., Ahmed H.R., Strauss D.H., Clark L.T., (2021). Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document Version 1.1. Cambridge and Boston, MA: Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center). Available at: https://mrctcenter.org/diversity-in-clinical-trials/
DID YOU KNOW?
REDCap File Repository Feature
Did you know that the file repository feature in REDCap is a great place to store and retrieve files and documents? Study teams can upload files like protocols, instructions, and announcements here to save for retrieval later, or download previously uploaded files. It stores all data and syntax files when data is exported using the Data Export tool. Additionally, the file repository automatically stores signed and dated PDF copies of eConsents when using the eConsent Framework. It is like having a mini Box folder for your REDCap Project.
Please note that not all user roles have access to the repository. If access is needed, please submit a request using the User Rights/Roles Request form. The User Rights link can also be located on the main REDCap page (towards the bottom of the page) or in any project on the left hand side under Applications
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 Oncology CRU would like to welcome Natasha Watts, Regulatory Coordinator Sr and Emily Watson, Regulatory Coordinator, to the NCTN Team!
- The Dermatology/Pathology CRU would like to congratulate:
- Ada Golowiejko for promotion to CRC in the BRPC
- Christian Cook for promotion to CRC in the BRPC
- Aisha Cato for promotion to CRC in the BRPC
- The Dermatology/Pathology CRU would like to welcome:
- Grace Morningstar to the BRPC as a Research Tech
- Jeannie Sparks to the BRPC as a histology tech
- Benjamin Dosan to the team as a CRC
- The Population Health Sciences CRU welcomes:
- Leslie Zapata Leiva, CRS, Sr.
- Sarah Jackson, CRC
- The Medicine CRU welcomes Carolina Quiroga who joined Medicine - Center for Aging as a CRC on April 5th
- Members of the Primary Care Research Consortium (PCRC) Team did 752 End of Study Visits in 15 days. This was an enormous undertaking that required a HUGE amount of data entry into an incredibly slow database. We could not be more proud of their dedication, energy and resolve to ‘GET THE JOB DONE’ – and they got it done with 30 minutes to spare on a Friday afternoon! Kudos to Kim Leathers, Taylor Harris, Liz Earnhardt and Erin Burks (honorary member) for their tenacity and accomplishment!
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