Duke Clinical Research Update October 7 2020

Wednesday, October 7, 2020
This image is the Duke Clinical Research Update Banner

 

 

 

 

 

 

 

 

 

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

 

Training and Documentation Requirements for Researchers Using N95 and PAPRS at Duke

It has come to our attention that there are additional OSHA requirements for individuals using respirators (PAPRs or N95 masks). 

 

  1. If you are using a respirator to limit exposure to SARS-CoV-2 from patients and/or COVID-19-positive individuals, please use the below instructions to complete and submit the medical clearance form to EOHW and to complete OSHA-required training.

 

 

 

 

 

Associated risk of exposure to tuberculosis  – due to the associated risk of exposure to tuberculosis when interacting with patients or sick individuals, employees in this group will also need to complete the following related to OSHA Tuberculosis requirements:

 

2.  If you are working with SARS-CoV-2 in the laboratory setting and your OESO-approved SOP references use of a PAPR or N95:

  • Follow the GHRB respirator policy if working in GHRB. Those working in GHRB will be trained by DHVI safety staff on respirator use and will use the GHRB respirator medical clearance form.
  • Otherwise, please be in touch with OESO Laboratory Safety (labsafety@duke.edu) for a lab-specific respirator policy if you don’t already have one. Lab personnel using respirators for SARS-CoV-2 outside of GHRB will use the medical clearance and training links shown above, though tuberculosis training and PPD testing are not required for SARS-CoV-2 laboratory work.

 

Update:  Guidance for Clinical Research Involving Participants Currently or Previously Infected with COVID19

The guidance document:  Guidance for Clinical Research Involving Participants Currently or Previously Infected with COVID19 was recently updated.  The changes are minor and are primarily for clarification.

 

Both the tracked changes version of this document as well as the final document have been posted to the DOCR website for review.

 

Student or External Collaborator Request

During this unique time of COVID, undergraduate students and external non-Duke collaborators are not currently permitted to conduct on-site research.  Plans must be submitted and approved for the following:

  • Duke or non-Duke undergraduates (remote work only)
  • Non-Duke graduate or medical students (any in-person work or unpaid volunteer remote work)
  • External collaborators (in-person work)

 

Exceptions may be considered under special circumstances and must be submitted using this form.  Please note that students and collaborators should NOT be on-site until an approval is granted.

 

https://redcap.duke.edu/redcap/surveys/?s=XT399FN38P

 

**Duke medical and graduate students do not need to be submitted through this process. They may be added to approved research plans following the same process for adding employees. Please contact your CRU with questions.

 

Those wanting additional information may also review the slide deck:  Prohibition of Access to Electronic Health Record

 

Brand Name Advarra to Begin Replacing Forte

One year ago the Forte team joined Advarra, adding world-class technology and professional services to Advarra’s industry-leading IRB, IBC, and research quality and compliance consulting offerings.

As a result, the name Forte is being phased out. Advarra will move forward as a unifying brand for all offerings.

These changes will be rolled out to:

  • Technology Product Names
  • Documentation and Training Materials

If you have questions or want to learn more about other aspects of this initiative, please consult our FAQ page on Onsemble.net.

 

Updates to DOCR CITI Training Policy

Researchers from Duke University Campus who submit a protocol through the DUHS IRB, or are listed as Key Personnel on a DUHS IRB protocol, must complete the Duke Health CITI modules.  DUHS IRB will not accept the Duke University Campus modules in lieu of the Duke Health CITI modules.  

 

The policy is posted on the DOCR web site https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/docr-policies-and-procedures .  Click on the tab for Training Policies.

 

Tip Sheet:  Clinical Research Sample Collection in the Clinical Setting

Clinical staff and research staff must establish clear communication channels and work together in order to successfully collect research samples in a clinical setting.

 

In order to maintain consistency across the clinical research setting, the tip sheet Clinical Research Sample Collection in the Clinical Setting has been created.  This tip sheet outlines requirements and best practices when collecting research samples in the clinical setting to ensure good clinical practice, patient safety, study integrity, and ultimately effective communication.

 

Zoom Security Update Requirements Cancelled

An announcement was sent to all Duke Zoom users last week regarding new security updates Zoom was enforcing by the end of the month. Duke and others in the higher education community appealed that decision to alleviate short-term disruption for users. As a result, the Zoom security updates will NOT be enforced on September 27, 2020, and it will be postponed until later this fall. More information will be forthcoming, including steps on how to check and update your Zoom meetings.

 

If you have questions or need assistance, please contact your local IT support or the OIT Help Desk. Visit https://oit.duke.edu/help to chat/submit a ticket, or email help@duke.edu.

 

A Few Words on Data from the Duke University Libraries Research Data Working Group

This is a Duke Medical Center libraries logo graphic.

 

Making Qualitative Data More Transparent 

Do you produce qualitative data in your scholarship? Whether it is interviews with human subjects or archival materials, qualitative data often requires specialized handling to ethically share these valuable data. In addition to providing the Duke Research Data Repository for publishing openly accessible data, Duke is also a member of the Qualitative Data Repository (QDR), which provides additional access restrictions and security for qualitative and mixed methods data. As a member of QDR, Duke scholars can deposit data at no cost. Contact datamanagement@duke.edu with any questions on depositing data or to arrange an instruction session on managing and sharing qualitative data. 

 

The Advantages of Linking Publications to Research Data

Open science describes an effort to make scientific processes, data, analyses, and publications accessible to all. A recent article found an association between publications with data availability statements that take the extra step of linking to unrestricted data in a repository and up to 25.36% (± 1.07%) higher article citation impact on average. The fact that data sharing encourages re-use may further enhance research impact. Considering this information and the need for increasing the speed of COVID-19 discoveries, particularly in light of the Duke School of Medicine Roadmap for Open Science, linking articles to open research data where feasible is highly recommended.

 

Adobe Sign 30 Day Retention Policy Effective: November 5th 2020

In compliance with our Adobe Sign policy, DHTS Duke Health is implementing a 30 day document retention policy effective November 5th, 2020.

 

Thirty days after a document is completed (signed by all parties necessary) it will be automatically and permanently purged from the Adobe Sign storage cloud.

 

This policy will remain in effect in perpetuity. Documents will be permanently purged and recovery will not be possible.  

 

Direct questions to DHTS Duke Health Adobe Sign Team Point of Contact Zachary Rigby

 

October is Cybersecurity Awareness Month

With Cybersecurity Awareness Month in October, Duke IT professionals are urging staff, faculty and students to #ThinkSecure to avoid falling for cybercrime. During the special campaign, “Security 2020: Protecting Yourself and Your Data in a New Threat Landscape,” staff, faculty and students can participate in webinars and other online activities to spot and report suspicious activity.

 

Please consider participating in our October training activities at duke.securityeducation.com for a chance to win great prizes. 

 

Also, see the recent article from Duke Today titled:  Protect Yourself Against Phishing, Win Apple Watch, Learn best practices for fighting phishing during Cybersecurity Month

 

Duke CTSI Multidisciplinary Vision Program (MVP) Award

The Duke CTSI Multidisciplinary Vision Program (MVP) Award provides funding to support novel translational research focused on improving health and healthy equity. We anticipate awarding up to three grants and have a total of $110,000 for awards. Award amounts vary based upon amount requested and budget evaluation by the Program Leadership Committee. Please note that the funding period is from 05/01/2021- 04/30/2022.

 

Proposals from teams of investigators from different disciplines are encouraged. Collaborations that bring together ideas, theories, methods and approaches from disparate scientific disciplines are particularly encouraged.

  • Letter of ‘Intent to Submit’ (Mandatory): October 22, 2020
  • Application Submission Deadline: November 19, 2020
  • Final Selection: January/February 2021
  • Project Planning Run-In Period: February 2021 through April 30, 2021
  • Funding Period: May 1, 2021 through April 30, 2022

 

Download the complete RFA.

 

2020 NIH Virtual Seminar on Program Funding and Grants Administration

The 2020 NIH Virtual Seminar on Program Funding and Grants Administration has been designed to provide you with a unique opportunity to learn about the NIH grants process, programs, and policies directly from NIH & HHS experts.

 

This event is intended to help:

  • Demystify the application and review process;
  • Clarify federal regulations and policies; and
  • Highlight current areas of special interest or concern.

 

Agenda and registration information can be found here:  https://nihvirtualseminar2020.vfairs.com/en/about-page

 

 

IRIS/ONCORE UPDATES

 

Don’t Forget to Update Your Protocol Status in OnCore!

 If your study enrollment is no longer SUSPENDED due to COVID-19 restrictions and you’ve received approval to resume activities, OR have decided to close enrollment permanently, please remember to update the protocol status in OnCore to “OPEN TO ACCRUAL” or “CLOSED TO ACCRUAL”.  Be sure to select the OPEN or CLOSE TO ACCRUAL buttons to make this change. 

 

DO NOT select “Undo Suspend” if your study and/or enrollment was temporarily suspended at any time.  The undo suspend button should ONLY be selected if the suspended status was selected in ERROR.  

 

If the undo suspend button is selected, the suspend status does NOT appear in the protocol status summary.  Thus the suspension will not be included in any reports nor will it be factored into your enrollment metrics.   

This image is of the PC Console in OnCore

 

Demographics in OnCore:  2 or more races and check all that apply

When the “2 or more races” category is selected in Maestro Care, it comes over to OnCore as “Unknown”.  Because multiple races can be checked in OnCore, the original workflow intended for all applicable race categories to be selected after a subject was registered.  For a variety of reasons, that isn’t happening and we are losing important information about our research populations.

The solution:

This image shows the race demographics options in OnCore

A “2 or more races” category will be added to OnCore and the interface mapping changed so that the categories are the same in both systems.  This will happen the first half of October.  This change only impacts new-to-OnCore participants since demographics don’t get overwritten once a participant is in OnCore.  If more details are known, check the additional race categories that apply but leave the “2 or more races” category checked.

For participants who are already in OnCore and have the “2 or more race” category selected in Maestro Care, we will have a script written to add that category in addition to any other race categories already selected on the OnCore demographics tab.  Unknown will be removed.  Depending on the vendor’s availability, these changes should be implemented by the end of October.

 

OnCore:  “NA” Option for NCT Number Field

If a study will not be registered on ClinicalTrials.gov, you now have the ability to enter “NA” in the NCT Number field in OnCore rather than leaving the field blank. While this is not a requirement, it may be helpful to indicate an NCT# is not expected for the study.

 

OnCore Deep Dive and Refresher Session:   October 23, 2020

Please plan to attend the OnCore Deep Dives and Refreshers Session via WebEx on October 23, 2020 from 2:00 PM - 3:00 PM (invite to be sent).   This session will focus on Institutional Approval Tracking in OnCore, Protocol Searches and helpful Reports for your day to day activities. 

 

These sessions are designed to offer you the opportunity to learn and apply useful information, workflow optimizations, and discuss topics of interest to the OnCore user community. We welcome all OnCore users to these sessions regardless of to your role or level of mastery in OnCore. 

 

If you have specific questions or topic suggestions, please submit them to oncore@dm.duke.edu

 

 

DOCR NEWS

 

Two New Views Added to the Maestro Care Research Dashboard

The Research Billing Review Balance for Study Team shows patients that have charges that need Study Team review.  (Note:  DOCR ‘central charge’ review studies are not included) 

 

The Interested Patients – MyChart shows patients on ‘my studies’ (using the logged in user) that are associated as interested because the patient clicked I’m Interested in MyChart.

This image shows updated fields in MaestroCare

 

October/Fall CITI Email Correction Blitz

5 minute work-life-changer – it’s worth it, we promise!

As you may have seen in the most recent DOCR newsletter, we recently created a brief mini-course that explains how to ensure your CITI Institutional Email Address is correct. You should check it out. We are asking everyone with a CITI account, yep even you, to take a moment to view this training and check your CITI accounts to ensure the proper email address is entered.

OK cool… why do I care?

SO glad you asked! If your CITI email isn't listed correctly, your training completion will not sync properly with iRIS or other Duke systems. No matter your role on a project, study protocols you are listed on in iRIS will be held up because of it. Fixing this very common issue now will ensure your study team doesn't run into issues with protocol submissions in the future. 

How widespread is this issue?

VERY widespread. There are a LOT of people with the incorrect institutional email address listed in CITI. Actually, a majority of people signed up using their alias (firstname.lastname@duke.edu) but iRIS only recognizes training for those who have listed their NetID@duke.edu email address.

Fine… if I do this, who am I helping out?

What a thoughtful question. Not only will correcting your CITI email help out you and everyone else who does extra work and has timelines impacted due to this issue (RPMS, IRB, PIs, etc.); but it will also help out our friend Parker in DOCR, who responds to at least 50 inquiries each week about protocols that are held up in iRIS because of CITI training completion. If you don’t do this for you and your study team… do it for Parker.

Thank you! Feel free to spread the word! And, please accept our deepest appreciation for each and every one of you who takes a moment to help make a bunch of jobs just a little more efficient.

 

Have You Registered for Your Society for Clinical Research Sites Account?

The Society for Clinical Research Sites (SCRS) was founded in 2012 in response to the growing need for a global organization representative of the needs of clinical research sites. SCRS currently represents over 9,500 research sites in 47 countries. SCRS’ mission is to unify the voice of the global clinical research site community for site sustainability. SCRS is an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise.

 

Duke has a membership to SCRS that allows employees to create a free account.  Follow these instructions to create your free account and explore the mySRCS benefits available to you!

 

  • Go to myscrs.org
  • Click "Join SCRS" in the top right to create an account
  • Indicate your organization is already and SCRS member and select Duke University Medical Center
  • User your duke.edu email address when registering

 

Membership includes access to Webinars, Newsletters, Site Management Modules, and Virtual Trial Capability Training.

 

 

RECRUITMENT INNOVATION CORNER

AWARE for All -- Raleigh

 

Want to engage your research participants even more?

This image is the CISCRP logo

 

Invite them to an event that is designed to educate them about clinical research!  The Center for Information and Study on Clinical Research Participation (CISCRP) is a nonprofit organization dedicated to educating and informing the public, patients, medical and research communities, the media, and policy makers about clinical research and the role each party plays in the process.

 

They are putting on a FREE event for participants and researchers alike!  AWARE for All – Raleigh is a free program that aims to educate people about clinical research so they can make informed decisions about their health.  This virtual event will include:

 

 

This image is the Aware for All Raleigh NC advertisement

October 22nd at 4:00 pm - 6:00 pm

  • Health exercises
  • A ceremony to honor clinical research volunteers
  • Informational presentations
  • Community organizations
  • Research organizations (Duke has a poster session!)
  • Local physicians and patients

This would be a great opportunity to share with your participants, family, friends and anyone else that may be interested in research!  Put the patient in charge of their health!  You can REGISTER HERE!

 

CISCRP is also a great resource for coordinators and investigators!  They help research professionals better understand their participants with facts and figures, polls, surveys other resources, while promoting a greater awareness of clinical trials. Additionally, they offer brochures, videos, books, posters and other materials that help clients and patients understand clinical research, and provide opportunities for professionals to stay involved 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!  Our services are FREE and you can Email us at studyrecruitment@dm.duke.edu  if you have any questions!

 

Follow us on Facebook at Discover Duke Research.

 

 

 

 

DID YOU KNOW?

Sponsor Site Questionnaire FAQs Regarding Maestro Care

The Sponsor Site Questionnaire FAQs Regarding Maestro Care is available on the DOCR website under the Tip Sheets for Maestro Care.  Find it here or navigate to it via the website.

 

Click on Maestro Care in the middle of the DOCR home page.

This is a screen shot of the DOCR website home page.

Click on Maestro Care Tip Sheets.

This is a screen shot of the DOCR website showing the location of Maestro Care Tip sheets.

 

Click on the title of the document.  The link leads to a list of Maestro Care Tip Sheets located on the Wiki.  Choose the Sponsor Site Questionnaire FAQs Regarding Maestro Care from the list.

This shows the location of the Sponsor Site Questionnaire FAQ on the DOCR website

 

 

REDCap:  Did you know you could add a Custom Record Label to your project to easily identify records?

Name, MRN, or any other field that is collected in the project can be  appended to any record name (e.g., Study ID) as the record is displayed on your data collection instruments

In the Project Setup Page, click on Additional customization , Set a Custom Record Label:

This shows the Additional Customizations button in REDCap

This image shows how to Set a Custom Record Label in REDCap

This will display when adding a record:

This shows the add a new record button in REDCap

In the Record Status Dashboard:

This image shows the Record Status Dashboard in REDCap

When the record is selected:

This image shows the Data Collection Instrument panel in REDCap

 

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.

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This image is of a Duke West Campus building.

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