Duke Clinical Research Update

Wednesday, January 15, 2020
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

 

 

 

 

 

Support Office Hour

 

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

Every other Tuesday, 1 PM, via WebEx. More information.


Research Community News

 

Maestro Care “Opt Out” Changing to “Restricted Communication”

As of January 14, 2020, the Maestro Care Research status formerly known as “Opt Out” will be known as “Restricted Communication” for patients who have taken the necessary steps to opt out of research contact.  Providers are not prohibited from discussing research opportunities with patients who have a “Restricted Communication” designation when the provider deems the research appropriate for the patient.  Please note the Research status depicted in Maestro Care before January 14, 2020 and the way the screen will appear as of January 14, 2020.

 

Maestro Care:  RSH View Only with Slicer Dicer Template

Slicer Dicer is now available for approved Maestro Care end users with a Research View Only template.  To receive RSH View Only with Slicer Dicer template, contact your unit’s CRU Research Practice Manager.  If eligible to receive the template, the RPM will make the request via the existing Service Now access request process.

 

CITI Single IRB (sIRB) Course Now Available for Duke Health CITI Users

Duke Health has acquired access to the CITI Single IRB (sIRB) Course for all Duke Health CITI users.

This optional course provides an overview of the use of Single IRBs in relation to the 2018 National Institutes of Health (NIH) policy requiring sIRB review for most human subjects research it conducts or supports, which significantly expanded the number of studies requiring sIRB review and anticipated.

For those interested in taking the sIRB module in CITI:

  1. Go to the CITI Program website: https://www.citiprogram.org
  2. Login to CITI correctly using the blue Log In button in the top right corner of the screen
  3. Select Log In Through My Institution
  4. Scroll to select Duke Health as your Institution
  5. Shibboleth authenticate with your NetID and password

Logging in via these steps will ensure that you will be able to access the sIRB training through your Duke Health CITI account.

To add the new course to your learning:

  • Go to Institutional Courses
  • Select the View Courses button next to Duke Health
  • Scroll to the bottom of the page
  • Under Learner Tools for Duke Health, select Add a Course
  • Select Single IRB, then Next

This will add the course to your list of available CITI courses.

For additional information about the CITI Single IRB (sIRB) Course, visit https://about.citiprogram.org/en/blog/getting-ready-for-the-common-rule-single-irb-requirement/.

 

CAMRD Project Application:  Process Change Update

Beginning in February 2020, new Center for Advanced Magnetic Resonance Development (CAMRD) project applications and renewals will be submitted through REDCap.  This will replace the current Word application that study teams send via email to CAMRD for review.  The remainder of the submission process will remain the same.

Further information will be available on our website once the application becomes active. Please contact the CAMRD team via email with any questions: CAMRD-technologists.dm@duke.edu.

 

Interactive Workshop:  Conducting Reproducible Research with Git, Github, R, and RStudio

The ASIST Office will host an interactive workshop on conducting Reproducible Research with Git, Github, R, and RStudio.  This workshop is eligible for 2 hours of Graduate School RCR Credit and fulfills the Collaborative In-Person RCR requirement for Duke Faculty and Staff.

January 23, 9:00 AM - 4:00 PM, Trent Semans Center, Classroom 4 (room 4067)

Speaker: Rob Schick, PhD from the Marine Geospatial Ecology Lab

Register at http://bit.ly/Jan23GitR

More information about other upcoming RCR workshops can be found on DOSI website.

 

Clinical Trial Design Lab June 29th and 30th Boston, MA

The Johns Hopkins University-Tufts Trial Innovation Center is hosting a 2020 Design Lab in partnership with MIT. The Design Lab provides a place for a diverse group of stakeholders to come together in a collaborative, confidential, case-based workshop to focus on innovative study design. JHU-Tufts Trial Innovation Center is seeking applications from investigators who are interested in pursuing an innovative clinical effectiveness trial design. 

Important dates:

  • Proposal submission deadline: January 30, 2020
  • Proposal selection date: February 6, 2020
  • Design Lab: June 29 and 30, 2020

Queries regarding this opportunity should be directed to Marisha Palm, mpalm@tuftsmedicalcenter.org.


IRIS/ONCORE UPDATES

 

Swing into the New Year with these OnCore Tips

We reviewed Service Now to identify the most common questions during the past year.

The Maestro Care interface:

The participant isn’t showing up in Maestro Care!

The #1 Reason:  Someone was in the Research Studies record in Maestro Care while you were updating OnCore.

How to resolve:

Step 1. Close the Research Studies record.

Step 2. From the Subject Console in OnCore, click on the Submit button from the Consent tab.

Other possible reasons:

  • The participant was manually entered in OnCore and the MRN is not in all caps and/or the participant’s name entered in OnCore does not match what is in Maestro Care.
  • The date of consent is not entered in OnCore.
  • The information for the protocol hasn’t been sent to Maestro Care.   You should see “Protocol was sent to Maestro Care” below the status dates on the OnCore Status tab. If you don’t, email DOCR-Startup.

OnCore doesn’t find my participant when I go to register them, but I can see them in Maestro Care!

The Reason:  Without going into too much detail, if the participant hasn’t had a hospitalization or clinic visit entered in Maestro Care since go-live (May 2018), they haven’t made it to the staging database where OnCore looks for Duke patients.

How to resolve:  Manually register the participant in OnCore and the interface will match up the participant in Maestro Care. 

Don’t know how to manually enter participants? There’s a tip sheet for that, Subject Registration (see page 2).

 

The iRIS interface:

The consent form / verbal consent script information did not come over from iRIS!

The Reason:  In order for consent information to be sent by the interface, the document:

  1. Has to be in the consent section in iRIS

    2. Must have a consent category selected (e.g., adult consent, minor consent, etc.),  and

    3. Must be in the approved and watermarked by the Duke Health IRB

How to resolve:  Someone from the study team will need to manually add the consent information to the IRB Reviews tab in OnCore.  You have to have protocol management permissions to do so.

Don’t know how to enter consent information in OnCore? There’s a tip sheet for that, Adding Consent Information

Since the Duke IRB does not approve consents if they are not the IRB of record (e.g., if you are using a central or single IRB) and they do no watermark verbal scripts, you will have to manually enter the information in OnCore each time you submit a new consent to the Duke IRB for administrative review. 

 

iRIS Summer Release

The Duke iRIS team is pleased to announce that the installation of the 2019 Summer Release will go live in the Production environment on January 17th.   Please find pertinent information below.

Additional information will be communicated via iRIS Notifications.

     1. Bug Fixes: Items addressed by iMedRIS as system bugs that have been fixed

Description

  • When selecting the “Entire View of Application” tab, screen displays blank page
  • System Error when generating a PDF packet
  • Triplicate email notices sending for IBC protocols scheduled to Auto Expire
  • Inability to view the Reference Number on the Committee Submissions screen

 

     2. New Features:  Below is a comprehensive list of new features for Researchers, CRU, and Specialty Committees

Description

  • Changes to Reference Number
  • Restriction to One Application in Process at a Time
  • Removal of the ability to Add and Edit Documents and Consents Outside of a Submission Form
  • Addition of screen when adding documents to a form attached to a submission with documents previously attached
  • Updates to Key Study Personnel (KSP) Section of IRB Application (Only)
  • Updated Submission History Display
  • Highlighted Modification content on a form where modification request has been linked by the board
  • New Pop Up Message to indicate the start of the Initial Submission Packet
  • Drag & drop Functionality in Document upload
  • Functionality to remove tasks from the Protocol Task list
  • Protocol Correspondence now Viewable from Protocol workspace
  • Ability to address tasks and issues from added buttons on Protocol Submission Status Panel
  • New Columns Available on Protocol Tasks Section on Protocol Workspace
  • Download Find a Protocol Search Results in Excel

  • Correspondence configuration that excludes RB roles of your choice from contact list

  • Review Board Sticky filters

  • Ability to switch between Multiple Boards

 

     3. iRIS User Guides (Coming Soon): The highly anticipated release of User Guides have arrived.  Please find comprehensive User Guides on the DOCR website, iMedRIS webpage.

 

     4. CITI Update: In order to provide the most accurate training information to iRIS, we would ask that ALL Duke Employees, please log in to your CITI account to validate that your email address listed is your netID@duke.edu.  iRIS validates training records first, off of the primary email listed which, must match in both CITI and iRIS for accurate training records to automatically merge to your account.  See screen shots below on how to complete steps in CITI:

1) Log in through my institution & select Duke Health

2) In the upper right hand corner, select the drop down arrow located next to the User’s Name and select Profiles
3) Select Institutional Profile>Edit Profile

4) Find Institutional email address and verify that the listed email is your netid@duke.edu

5) Scroll to the bottom of the page and select Update


DOCR NEWS

 

Express Start On-boarding has Launched!

We have now officially launched The Express Start Onboarding Program-CRC!

To navigate to the LMS modules:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=dowbt000000000040406

This program consists of 4 self-paced e-learning modules are suggested for the following positions at Duke:
* Express Start may be very useful to new clinical research professionals in other job classifications new to Duke (Ex: RPLs, Regulatory Coordinators, ARPMs, and RPMs)

  • CRS
  • CRS, Sr.
  • CRC
  • CRC, Sr.
  • CRNC
  • CRNC, Sr.

The Express Start Onboarding Program consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke.  Some of the topics include:

  • Roles and responsibilities
  • Clinical research organizations structure at Duke Medicine Central offices and resources
  • Clinical research systems
  • Portfolio management
  • Career progression within clinical research professions

The Courses

  • What is a Clinical Research Coordinator at Duke?
  • Navigating Clinical Research at Duke: What You Need to Know
  • Introduction to the Clinical Research Workflow at Duke
  • Getting Started with Your Clinical Research Portfolio

 

ARPM and RPM Job Classification Updates and Job Request Form

School of Medicine HR, Rewards and Recognition, and the WE-R team have been working on developing more contemporary job descriptions for the Assistant Research Practice Manager and Research Practice Manager job classifications. Our goal was to better align these positions with the WE-R competencies, capturing the current scope of responsibilities for these important roles. These revised job descriptions are currently available on the Duke HR website and WE-R website.

 

Also effective January 1, 2020, we implemented a job request form for all ARPM and RPM positions. This includes new positions as well as reclassifications of filled and vacant positions. The hiring manager (or person most knowledgeable about what the position requirements are) should email wer-jobs@duke.edu to request access to the form. Once the manager completes the request form, it will be routed to WE-R for review. Someone from WE-R will respond to your request within three business days. Additional details about this process are located on the WE-R website under ‘Creating, Reclassifying, and Hiring Clinical Research Positions.’

 

Workforce Engagement and Resilience (WE-R) Town Hall

Please join Workforce Engagement and Resilience (WE-R) for a town hall update on January 30th from 9 AM -11 AM. The event will be held at Trent Semans Great Hall and is open to all interested faculty and staff.  During the session, we will discuss the history of the job classification project, provide Tier Advancement updates and results, and details on the expansion of WE-R efforts into onboarding clinical research professionals. Coffee and donuts will be provided during this event.

Learn more about the Research Professionals Network at docr.som.duke.edu.

 

Research Professionals Network:  Resume Preparation and Enhancing Your Career Journey

Thursday, January 23rd at 1:00-2:00PM in Trent Semans Great Hall

Enhancing Your Career Journey at Duke will take you through self-reflection and the steps necessary to take you to the next level in your career pursuit.

Whether you are seeking a new position, career advancement, or new professional pathway, this short session will provide tips to strengthen your portfolio, enhance your resume, and identify opportunities for improvement.  We will explore how organizations select applications and reasons why some never make it through the pipeline.

Having an open and honest conversation about what you bring to the table is the first step to a successful career journey.

Speaker:  Jemma Boler from Duke Human Resources/The Resource Center

Light refreshments will be provided. Please use this link to register.

Learn more about the Research Professionals Network here.


RECRUITMENT INNOVATION CORNER

 

Diversity

Do the volunteers in your studies resemble our communities? The short answer is probably not.

 

Even though racial and ethnic minorities make up about 40% of the U.S. population1 (and about 56% of the Durham County population!), “most clinical research includes participants who are overwhelmingly non-Hispanic whites and, until recently, male.”2 Even more troubling is that this lack of representation frequently occurs for conditions where minorities are particularly susceptible (e.g., kidney disease, diabetes, heart disease, etc.).

“Clinical trials of ‘enriched populations,’ … by themselves they won’t increase our understanding of the effectiveness and safety of therapies for the broader population. Without diversity in clinical trials, those discoveries… will not happen.”2

Vanderbilt University offers the “Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials” course, freely available on the Coursera website.  This course reviews topics such as:

  • Barriers and facilitators for minorities in participating in clinical research
  • Community engagement and effective communication
  • Educating potential participants about clinical trials
  • Person-centered consent
  • And more!

We highly recommend setting aside some time to take this FREE, self-paced course so you can apply what you learn to your recruitment strategy.

The RIC is always available to help you identify and utilize tools and partners to meet your recruitment and retention goals. Let’s work together to solve the diversity dilemma – reach out for a free consultation today.

  1. U.S. Census Bureau (2018): https://www.census.gov/quickfacts/fact/table/US/PST045219
  2. Diversity in clinical trials defines good science and better medicine. StatNews. Jan 17, 2019. https://www.statnews.com/2019/01/17/diversity-clinical-trials-good-science-better-medicine/
  3. https://datausa.io/profile/geo/durham-county-nc

DID YOU KNOW?

 

Sending Signed eConsent from REDCap

The HIM group has a new email address for sending signed eConsent from REDCap.

If you are using eConsent in REDCap and have configured your project to automatically email a copy of the signed eConsent to the HIM group, please update your REDCap project to use the following email address: HIMDocumentMgt@dm.duke.edu.

Instructions for setting up eConsent have also been updated to include functionality now native to REDCap.  The updated instructions can be found on the DOCR website


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

 

  • DUSON welcomes Jessalyn Byrd, CRC, who started in December.

PARTNER RESOURCES

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