Duke Clinical Research Update November 4 2020

Wednesday, November 4, 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

 

A Note of Caution from the Duke Health Information Security Office

The Duke Health Information Security Office is alerting the Duke Community that the search terms “COVID” and “vaccine” are currently trending as high priority hacking targets.

The article linked below is just one example of how hackers are employing these tactics.

In the article, Indian COVID-19 vaccine manufacturer Dr. Reddy’s Laboratories was hit with a cyber-attack that forced it to shut down its plants in Brazil, India, Russia, the U.K., and the U.S.

https://securityaffairs.co/wordpress/109994/hacking/covid-19-vaccine-manufacturer-hacked.html

 

A Few Words on Data from the Duke University Libraries Research Data Workgroup

 

This image is a data word cloud.

Making a Plan for a Plan

Data management planning at the beginning of a project will set you and your team up for future success! Upfront discussions about data organization, storage, description, sharing and retention will save time over the course of a project and lessen the workload at the end. You may consider using Duke’s Data Management Planning Guidance Document or the DMPTool to complete the plan and submit it for review. Consultants are happy to provide feedback on your plan at any point!

 

Data Drop: A Highlight from the Duke Research Data Repository

The Duke Research Data Repository is celebrating a milestone of reaching 100+ data deposits! One of these recent datasets explores the applications of convolutional neural networks and drone imagery technologies for seabird population monitoring in the Falkland Islands.

Title: Data from: A deep learning approach for large-scale detection and enumeration of Black-browed Albatrosses and Southern Rockhopper Penguins in drone imagery

Affiliation: Duke University Marine Laboratory

Subjects: deep learning, convolutional neural network, sea birds, drone aircraft

Contact: Madeline C. Hayes 

 

 

IRIS/ONCORE UPDATES

 

Use of Citrix Web app to Access OnCore

In light of the recent concerns surrounding VPN, we would like to remind users that OnCore may be accessed through the Citrix Workspace.  The Duke Clinical Research Update newsletter recently ran an article on the addition of OnCore to the Citrix Workspace.  At this point in time, we would prefer the Duke Clinical Research Community to use the web app to access Duke Citrix instead of the desktop app.  If employees are working remotely (e.g., from home), access to Duke Citrix applications is now only available via the Web by visiting https://citrix.duke.edu

 

See the document Duke Citrix Remote Access Changes which walks employees through the steps for how to access Duke Citrix remotely.

 

Policy:  Protocol Status Update Requirements in OnCore

The Duke Office of Clinical Research has posted a new policy titled Protocol Status Update Requirements in OnCore.  The purpose of this policy is to define the requirements for updating the protocol status in OnCore.

 

This policy can be found on the DOCR Policies and Procedures page in the Ongoing Study Management section.

 

OnCore:  What to do when a participant completely withdraws from a study? – Revised workflow & updated tip sheet

The Participant Withdrawal from Study tip sheet has recently been updated.

  • For participants who withdraw prior to having an on study status, the Withdrawn status in the consent section can be used.

This OnCore image highlights the Withdrawn option available in OnCore.

  • For participants who have an on study or later status, enter an Off Study Date and choose an off study reason related to withdrawal (e.g., Subject withdrawal from non-therapeutic protocol).
  • For participants who agree to continue with follow up, add a Follow-up Start Date and refer to the tip sheet.  

 

New OnCore Tip Sheets

Two new tip sheets have been developed and posted to the DOCR OnCore support page.   

  • Institutional Approval – How to check what is outstanding for your study and who to contact for any questions. 
  • PI Changes in OnCore – How to make PI changes in OnCore.  TIP - To update, add an end date for the “old” PI and add a start date for the “new” PI. The dates also have to be at least one day apart.

 

OnCore Deep Dives and Refresher Session Slides  

Unable to attend the session this past Friday the presentation is now available on the DOCR OnCore Support page!

 

OnCore Protocol Searches    

On Wednesday, October 28, the information on the OnCore Annotations Tab was updated for the CQMP, ClinicalTrials.gov and Maestro Care teams.  Changes to the annotations tab removes any fields you may have checked under this section in your saved protocol searches.  You may need to revise any saved searches that uses data from the annotations tab. 

 

  1. Select the saved search from the Protocol Search Console
  2. Recheck the items in the Annotations section to add them back in the saved search
  3. Select UPDATE to save

 

If you do not have any saved protocol searches and would like to review additional guidance on how to set up a protocol search for your studies, please reference the Tip Sheets available below: 

 

 

DOCR NEWS

 

Urine Pregnancy Kit Ordering Updates

Pandemic-related manufacturing changes and subsequent supply issues have made it necessary for DOCR to begin using a different brand of kits for urine pregnancy screening.  Effectively immediately, we will use the Cardinal hCG Combo Rapid Test (B1077-23).  Because the procedure and interpretation of results are different from the Quidel QuickVue+ kits that were being used, DOCR has updated training that will be required to use the Cardinal kits. Urine Pregnancy Screening for Research class dates for the remainder of 2020 are:

 

Tuesday, November 17, 11:00 a.m.-12:00 p.m. via WebEx

Offering ID: 00150032

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103644

 

Thursday, December 10, 11:00 a.m.-12:00 p.m. via WebEx

Offering ID: 00150033

Registration Link:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=class000000000103645

 

If you need training and are unable to register because a class is full, please contact DOCR.Help@dm.duke.edu.

 

To place an order for urine pregnancy kits, please complete the REDCap survey at https://redcap.duke.edu/redcap/surveys/?s=NRXDKNNAMF and upload your completed IRI form to the survey to cover the cost of the kits before submitting it.  If you have any questions please contact DOCR.Help@dm.duke.edu.

 

Updated Phlebotomy Competency Training for Research Study Personnel

 The DOCR Phlebotomy Competency Training for Research Study Personnel has been updated to provide a range of required sticks for training requirement completion.

 

This range was added to account for varying level of previously gained competency in drawing blood and is determined by the individual who is clinically competent to draw blood and performing the observation.

 

Full text of the updated policy can be found here.

 

 

RECRUITMENT INNOVATION CORNER

Coming together, staying together, and working together = SUCCESS!

 

COVID-19 and the global pandemic have certainly forced us to learn to work in new ways, with new people and occasionally interesting co-workers (kids, dogs, cats, and spouses). As unsettling as it has been, we have also seen an enormous amount of collaboration between departments, divisions, institutes, and centers, breaking out of their silos to work together to achieve common goals. Many CTSI staff and Cores have found themselves taking on exciting new challenges and activities, working with DOCR and DUHS, supporting work needed to

 

  • Engage the community in order to understand their needs, fears, concerns, and perceptions
  • Create a new core to support equity, anti-racism and anti-bias in clinical research across the enterprise
  • Improve awareness of and participation in COVID-19 research
  • Support study teams transitioning their work to a remote environment
  • Create lay-friendly, culturally tailored e-consents and pre-screening forms
  • Launch a new Facebook Page and provide a social media marketing service
  • Build a COVID clinical trials directory website
  • Launch a new certificate program to train study staff in strong, supportive engagement, recruitment and retention activities
  • Make changes to the current Duke Health clinical trials directory to support Spanish translations and the option to push studies on the directory with statuses other than “open to accrual”
  • Stand up a brand new clinic specifically for Duke COVID Research
  • Create a COVID Research Call Center

 

Perhaps the most impressive thing about all of this work is the tremendous determination of so many groups to come together to support one another, identify synergies and leverage efficiencies to ensure that the research we desperately need to end the pandemic gets done as quickly, efficiently, and safely as possible.

Image of birds flying with text:  If everyone is moving forward together, then success takes care of itself.

To all of you (and there are far too many to name), we tip our hats to your fortitude, resilience, and perseverance.

 

The CTSI Cores and the RIC are here to serve you – get in touch when you need us (and even when you think you don’t).

 

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?

Did you know we will be upgrading to REDCap v10?

 Please be on the lookout for specifics regarding the downtime message on the main REDCap page, we are currently scheduled to upgrade on November 19th.

 

New functionality includes Field Embedding (similar to SHAZAM functionality), DAG Switcher, & Record-level locking.  Review a full list of new features here.

 

 

TRAINING OPPORTUNITIES

New Training Module: Research Related Agreements: The Basics for Clinical Research Study Teams

 

Text Box:  Research Related Agreements:  The Basics for Clinical Research Study Teams.

This new DOCR course is available in the LMS and takes about 20 minutes to complete.

 

This module is designed to provide study teams with an overview of typical clinical research related contracts and agreements and how they are handled at Duke, along with an introduction to the Duke Office of Research Contracts (ORC). This quick course is great for anyone new to a regulatory role in clinical research or new handling research related agreements at Duke. It is also a good refresher on the topic.  

 

The course provides guidance to help develop a baseline in the following WE-R clinical research competency: Research Operations: Contracts and Agreements

 

Link to course

 

You can also find this course on the DOCR WE-R Competency Training page under the Contracts and Agreements competency.

 

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.

Image of 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