Duke Clinical Research Update

Wednesday, October 2, 2019
By Duke Office of Clinical Research (DOCR)
Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

Research Community News
iRIS/OnCore Updates
DOCR News
Did You Know?
Training Opportunities
Clinical Research Employee Highlights
Partner Resources


 

Support Office Hours

 

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. Click link for dates.


Research Community News

 

Coverage Analysis and Payment of Copayments and Deductibles Policy for Clinical Research

Coverage Analysis (CA) is a financial review of a Clinical Research Study that is required to be performed pursuant to the National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1).   CA is required for any clinical research study requiring Duke University Health System (DUHS) resources in which study-related patient care charges will be generated.  As part of the CA process, any potential charges that may be generated from protocol-required activities are identified, coded, and interfaced with Maestro Care to facilitate the accurate routing of charges.

CA is important for many reasons including:

  • Facilitating Billing Compliance
  • Mitigating Risks
  • Avoiding billing errors
  • Assisting in budget negotiations

The Duke Office of Clinical Research (DOCR) will complete a preliminary CA prior to the study initiation meeting and discuss its contents with the study team during the meeting.  The objectives of the CA include:

  1. Identifying and documenting whether a study is a Qualifying Clinical Trial (QCT) that allows for billing certain study-specific items/services to insurance pursuant to applicable laws and regulations.
  2. Determining and documenting billing designations for all patient care costs required by the study.
  3. Referencing applicable billing regulations, insurance coverage decisions, and supporting information that support insurance billing as appropriate.

Effective October 1, 2019, new industry-funded studies requiring a CA will be charged a fee of $2,500 at Institutional Approval.  The fee applies to new industry-funded studies that do not yet have an agreed upon negotiated budget.  Also, this fee is not subject to F&A recovery.  

For additional information, see the Coverage Analysis (CA) and Payment of Copayments & Deductibles policy on the DOCR website.

 

Access of Protected Health Information (PHI) Policy and FAQs

The Access of Protected Health Information (PHI) Policy is located in eGRC.  Under the Health Insurance Portability and Accountability Act (HIPAA), this Duke Health Enterprise (DHE) policy establishes processes for DHE Workforce Members and contracted third parties to obtain authorized access to Protected Health Information (PHI) to perform DHE role responsibilities.

An FAQ sheet has been added to this policy in eGRC within the Policy Management Tab, following the Policy Statement, under the Attachments section. 

One FAQ of particular interest to Research Nurses:

I am a clinical research nurse coordinator, but I am also a registered, licensed or certified clinical professional (i.e., registered nurse, licensed practical nurse), do I qualify as “Clinical Staff” under the Access of PHI policy such that I can self-access my own record?

If your primary role at Duke Health is to support clinical research activities (i.e., clinical research nurse coordinator (CRNC)), then you do not qualify as “Clinical Staff” under the Access of PHI policy and may not self-access your own record.  Only clinical nursing professionals (i.e., Clinical Nurse, Clinical Lead, Ambulatory Care Nurse, Clinical Services Nurse) who are performing clinical services on behalf of Duke Health may self-access their record under the policy.

 

Office of Regulatory Affairs and Quality (ORAQ) Implements Changes

Starting November 1, 2019, the Office of Regulatory Affairs and Quality (ORAQ) will implement several changes that will impact institutional regulatory support at Duke University. At the request of the School of Medicine (SOM), ORAQ will implement the following changes with goals to improve the quality of regulatory submissions, increase efficiency and reduce delays with regulatory approvals, and decrease risk by ensuring compliance with federal regulations:

  1. Regulatory Review Requirements: All regulatory submissions associated with a clinical trial must be reviewed by ORAQ prior to submission to the U.S. Food and Drug Administration (FDA). The new requirements will be phased in over time and will start with reviews of initial applications.
  2. Costs for ORAQ Support: In order to sustain and expand resources, ORAQ will begin charging for regulatory support. ORAQ effort that is not already supported by a department or grant will be charged back to academic research departments.
  3. New Submission Processes: Any drug or biologic submissions sent to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) for research INDs will be submitted electronically through FDA’s Electronic Submissions Gateway (ESG) in non-eCTD format.

These changes were communicated by SOM leadership to Department Chairs in August and were subsequently shared with Clinical Research Unit (CRU) Directors and Research Practice Managers (RPM) in September.

For additional information, please see our frequently asked questions on the new regulatory review requirementsORAQ costs, and submission processes. If you can’t find the answers to your questions here, please reach out to us at ORAQ@duke.edu.

 

National Cybersecurity Awareness Month

This October Duke University and Duke Health will observe National Cybersecurity Awareness Month with a variety of activities from talks and outreach for faculty, students and staff, to a new CyberStrength quiz. 

When receiving an email, it is important to consider the safety of the message.  Before opening email attachments, clicking on links, or responding to a request, follow these steps:

  • Stop, even if the message appears to come from someone you know.
  • Think about the message context and confirm unexpected or unusual attachments or requests with the sender by contacting them directly, not replying to the email in question.
  • Check with the Security Offices (security@duke.edu) if you have any questions, or use the new “Report Phish” button available in Outlook,OWA, and mobile Outlook apps (KnowledgeBase: KB0031840).

As part of our collective efforts to fight phishing, Duke’s IT security offices are inviting staff, faculty and students to take a new CyberStrength quiz to test their phishing-detection skills. The new quiz, part of Duke’s National Cybersecurity Awareness Month in October, was developed in conjunction with Proofpoint, a service already in use at Duke for protecting accounts against malicious email links and attachments.

All Duke University and Duke Health faculty, staff and students who take the voluntary 15-question quiz will be entered into a drawing to win an AppleWatch. To take the quiz, visit (cyberstrength.security.duke.edu) or visit security.duke.edu between October 1-31st and log in using your NetID and password. 

For any questions or comments about the quiz, please contact security@duke.edu.

For additional information on further steps that you can take to protect yourself online, as well as to find out where various learning and awareness opportunities will be held throughout October, please visit https://security.duke.edu and to learn more.

Thank you for helping us to keep our community safe.

 

Announcing 2019 Research Staff Appreciation Awards

The School of Medicine Research Staff Appreciation Awards recognize staff members who provide exemplary support in the conduct of research.

Nominations for these awards are now being accepted and can be submitted online at the link below. A nomination can be submitted by any School of Medicine faculty or staff member. Nominators may only nominate one candidate. The application requires endorsement from the respective chair or center/institute director of the staff member. If the nominator is also the nominee’s direct supervisor and entity leader, please seek out letters of support to provide additional perspectives. Self-nominations will not be accepted.

To submit nominations for the 2019 SOM Research Staff Awards:

  • To apply, visit My Research Proposal, click on “Create New User” (or log in if you already have an account).
  • A step-by-step user’s guide for applying via the MyResearchProposal software is available on the CTSI website page ‘MyResearchProposal’.  Please click on the Applicant instructions.
  • Enter Access Code ‘SOM’ then select the “School of Medicine Research Staff Appreciation Awards 2019” opportunity and follow the instructions.
  • For questions concerning MyResearchProposal passwords or system issues, please contact myresearchproposal@duke.edu.

Applications are due October 24, 2019, and winners will be announced in December. Three awards will be presented.  Each winner will receive a certificate and $500.00.

 

Research Recruiters and CRCs Needed

The CTSI Community Engaged Research Initiative (CERI) is hosting a Community Consultation Studio in collaboration with Dr. Barrett Bowling.  Dr. Bowling would like to receive feedback from research recruiters and coordinators about barriers and potential solutions to recruiting and retention of the older adult population in studies for common chronic diseases.  The studio will be held on October 15, 2019, from 11:30 AM-1:00 PM in a Duke South location (TBD).  If you’re interested in participating please contact daphne.lancaster@duke.edu or call 919-668-1564.

 

FDA Humanitarian Device Exemption Webinar October 21st, Noon – 1:30 PM EST

The FDA will hold a webinar to discuss the updated Humanitarian Device Exemption Program Final Guidance issued September 5, 2019.

Registration is not necessary and following the webinar, a transcript, recording and slides will be posted at http://www.fda.gov/CDRHWebinar

For more information, go to the FDA website

 

Save the Date:  Duke Clinical Research Appreciation for Faculty and Staff

The annual Duke Clinical Research Appreciation Event for Faculty and Staff, “Navigating Your Path to Success”, co-sponsored by the School of Medicine and the Clinical Translational Science Institute is scheduled to take place Thursday, October 10th from 11:00 AM – 1:00 PM in the Trent Semans Center Great Hall and Atrium.  This drop in event is a celebration of the great work taking place in Clinical Research at Duke.  Mark your calendars now and stay tuned for additional details as the event approaches.

 

PACE Office Hours

The PACE Team is excited to announce that we will be offering an Office Hours session! This is an opportunity to engage the PACE Team with any issues you may be experiencing or ask any general PACE questions you may have, whether you are new to the service or a veteran user. This will be offered via WebEx and can be accessed via this link. Additionally, you can find a link to the sessions on the PACE Website. The first session will take place on October 8th from 1 PM – 2 PM and will take place every other Tuesday. If you have any questions regarding this, feel free to contact the PACE team at PACE_Info@duke.edu.

 


iRIS/OnCore Updates

 

OnCore and MRNs

When enrolling non-Duke participants an OnCore MRN will need to be generated for the participant.  Please only use the Generate button on the CRA console.  If the Generate button does not appear, please do not create a MRN number.  Instead, click yes beside the Automated MRN section of the PC Console>Main>Management tab. Once this selection is saved the Generate button will appear on the CRA console.  Any member of the team with Protocol Management access is able to update this section.

If your participant does not have a Duke MRN and the study uses Duke facilities (i.e.: clinic space, labs, radiology), you will need to request a Duke MRN.  To request a Duke MRN for a participant, please contact HIM via email, HimdataIntegrity@dm.duke.edu, or calling, 919-684-5525. Please provide the following information:   

  • Name
  • DOB
  • Gender
  • Address
  • Phone Number

Reminder:  An OnCore MRN cannot become the participants Duke MRN.  It is important to use the correct MRN type for your study.  If the study requires use of Duke facilities and/or Maestro Care orders, a Duke MRN must be used to register the participant in OnCore.

What if your participant has a Duke MRN, but it is not appearing in the Find Subject section?  You will need to manually enter the participant using their Duke MRN in the Subject Details section.  See page 3 of the Subject Registration tip sheet (https://duke.app.box.com/s/hxi2csntkky2wk8gbbhfkj1bhq0allms) for step-by-step instructions.

 

iRIS Best Practices:  Uploading Study Documents to iRIS and Naming Consent Documents

When uploading study documents to iRIS, there are a few best practices that can make life easier for both the study team and the IRB Reviewers:

  • Shorten long titles.  Documents have a 255 character title limit.
  • Do not include special characters in the document title.  Special characters are % , ; : ‘ “ & $* (any punctuation or special characters above the numbers on your keyboard)
  • Upload documents as .doc files

Through trial and error, the IRB has discovered that if these best practices are followed, the uploading of documents and reviewing documents will be a smoother process for all parties.

 

iRIS:  How to Delete an Unapproved Consent Form from a Draft Protocol

If you need to delete an unapproved consent form from a draft protocol in iRIS, follow these steps:

  • Open the Initial Review Submission packet
  • Select the 4.0 Consent Document(s) tab
  • Click the Red X to detach the unapproved consent form

 

Accessing iRIS Support

There is a new way to access iRIS Support. Click on the Help button, and then click the first link in the Help pop up. The link will display a support request form to complete that bypasses the Service Desk, and delivers your support ticket directly to the organization that can assist with your specific issue (ORI, DOCR or the Duke Health IRB team).  The help button also takes you to additional resources, forms and tip sheets to help with your work.

 

Need Help with OnCore?

You can now email OnCore@duke.edu directly to create a Service Now ticket.  One-on-one assistance is provided to anyone who contacts our team.  Often times, we are able to screen share via jabber or web-x to aid in the resolution of more complicated issues. 

Please don’t hesitate to contact us- we offer timely resolutions to your OnCore questions and concerns.  If you would like to request one-on-one assistance or training for your team, please email Kristy Astin and Susan Natoli.


DOCR News

 

WE-R:  Updated Research Oversight Standards (R07)

The annual performance review component, formerly known as the R06, has been updated to align with new clinical research management systems and research competencies.

The updated Research Oversight standards (R07) have been posted on the DOCR website. The general sentiment of these standards has not changed; however the wording has been updated to reflect contemporary systems and standard research competencies.

These standards will be included in the upcoming performance review process starting in 2020 for Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators.

 

Maestro Care Upgrade October 13, 2019

Maestro Care will be upgraded to the next version of the Epic electronic health record during scheduled maintenance on Sunday, October 13th.

Click this link to find the updated training materials to support the upgrade, https://medschool.duke.edu/about-us/news-and-communications/med-school-blog/preparing-upcoming-october-2019-epic-upgrade

 

 

Maestro Care:  Breaking the Glass to Obtain Information from Research Participants’ Medical Records

Recently, Duke University Health Systems reminded Maestro Care users about the importance of protecting the privacy and security of all patients.  This notice included new information regarding added security measures to protect the privacy of Duke employees who are also Duke patients.

A “Break-the-Glass” protocol has been implemented for all Electronic Health Records (EHR) of patients who are also Duke employees.  A “Break-the-Glass” notification will appear as a pop-up in the record unless the employee requesting access is listed as the attending or appointment provider for the most recent encounter for the patient.  The pop-up will include fillable fields for additional information that must be provided to access the medical record.

Duke employees who work in EHRs should keep in mind that patient records should only be accessed when it is required for their job, and only by a member of the patient’s care team or those designated and required to access these records for research studies.  It is a HIPAA violation to access the Protected Health Information (PHI) of any patient inappropriately.  It is also important to remember that any information about a patient’s care at Duke, even knowledge that is obtained incidentally, should not be shared with anyone who does not need to know for a legitimate work-related reason.  Accessing medical records without a legitimate business reason is subject to disciplinary action.  It has resulted in employee terminations and may cause significant issues for your study. 

Please follow these steps when you “Break-the-Glass” to obtain information from patient medical records for research studies:

  • Select “Record Review” as the reason for accessing the record.
  • In the free text box next to “Further explanation,” type “Screening for ProXXXXXXX” where ProXXXXXXX is your protocol number.
  • Type your NET ID password in the free text box next to “Password.”
  • Click “Accept.”

 

UPDATE:  NOW AVAILABLE to Clinical Research Specialist Srs New Reporting Tool Within Maestro Care:  Slicer Dicer

SlicerDicer is a self-service cohort building tool within Maestro Care where study teams can see counts of patient populations.  Study teams that have an approved Review Preparatory to Research (RPR) or an approved protocol with the DUHS IRB can view potential participants’ PHI for research purposes. 

The SlicerDicer tooI is currently available to clinical providers and it will be rolled out to research users in a phased approach.  It is already accessible to all CRCs (Non-licensed, CRNCs and Oncology CRNCs).  AND NOW SlicerDicer is available to Clinical Research Specialist, Sr staff that have the Research Assistant Maestro Care security template.  The final phase for research users is a research view only template with SlicerDicer. This is in development and then will be assigned per CRU leadership to current and future Maestro Care view only staff.

To see if you have SlicerDicer access, type “slicer” in the Chart Search box.

Here are links to useful SlicerDicer instructions

In addition, DOCR will host SlicerDicer office hours on Thursdays at 1:00 PM.  Meeting locations vary – see below.​

  • Thursday, October 17, 1:00 PM – 2:00 PM – Erwin Square 10th floor Room 1022
  • Thursday, October 24, 1:00 PM – 2:00 PM – Erwin Square 10th floor Room 1022
  • Thursday, October 31, 1:00 PM – 2:00 PM – Erwin Square 10th floor Room 1022
  • Thursday, November 7, 1:00 PM – 2:00 PM – Erwin Square 10th floor Room 1022

 

Live Streaming Tips and Tricks

Live streaming refers to online streaming media simultaneously recorded and broadcast in real time.  When you are watching a live stream, it is not uncommon to experience buffering.  Buffering is when the stream you are watching starts and stops, or in some instances stops completely.

What causes buffering?

  • Slow internet speeds on the users end
  • Wifi signal being weak and or degraded by distance or having to go through walls or other obstacles
  • Other users on your internet network hogging bandwidth
  • The stream sources server being overloaded with too many users
  • The stream sources server having internet issues
  • Your internet provider having fluctuations in their internet service

How to minimize buffering while streaming

  • Ensure you have a connection speed of at least 2Mbps to stream a video
  • Pause a stream for a minute or two to allow it to build up some data
  • Ensure that your browser is updated and that its cache is cleared

Since bandwidth continually fluctuates (especially with a wireless connection), we suggest you refresh your browser if your livestream is buffering or has stopped completely.

A special note to Research Wednesdays live streaming viewers: 

If you are unable to stream the session (the session starts and stops or freezes altogether), you can view the recording of the session on the Research Wednesdays page of the DOCR website when available:

https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/docr-services-and-initiativesprojects/training-and-communications/research-wednesdays

 

DOCR Job Opportunities:  Clinical Research Finance Associate

The Duke Office of Clinical Research has posted 2 Clinical Research Finance Associate positions.  These positions will support the OnCore Financials workflows of Industry-funded clinical trials and clinical research and will play a key role in the continued rollout of OnCore Financials and One Duke Budget throughout the Duke University School of Medicine.

For additional information and to apply, visit the Duke Careers website.

 


Did You Know?

 

REDCap Alert & Notifications

REDCap now has Alert & Notifications directly built in, thus the External Module is no longer needed (nor is the old Auto-Notify).

The Alerts & Notifications feature allows you to construct alerts and send customized email notifications. These notifications may be sent to one or more recipients and can be triggered or scheduled when a form/survey is saved and/or based on conditional logic whenever data is saved or imported.

When adding/editing an alert, you will need to:

  1. Set how the alert gets triggered
  2. Define when the notification should be sent (including how many times)
  3. Specify the recipient, sender, message text, and other settings for the notification.

For the message, you may utilize customized options such as rich text, the piping of field variables (including Smart Variables), and uploading multiple file attachments.

While similar in many respects to Automated Survey Invitations, Alerts & Notifications allow for greater complexity and have more capabilities. For example, alerts apply to both data entry forms and surveys, and they also allow for more options regarding who can be the recipient of a notification (project users, survey participants, etc.).

This can be found on the left 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

Detailed information about each offering and direct links to the offering are also available on the DOCR Course Listing.


Clinical Research Employee Highlights

The Neurology CRU congratulates Ashley Pifer on her ACRP CCRC certification.

WE-R has successfully completed the Tier Advancement cycle effective October 2019! We are sincerely grateful for all of the effort that the clinical research community has put into this important initiative!

Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 2.

  • Amelia Lorenzo from OB/GYN
  • Aubrie Coburn from Heart Center
  • Beth Mancuso-Mills from CTSI
  • Bobby Warren from Medicine
  • Ca'Lecia Fleming from Pediatrics
  • Carol Ann Wiggs from Oncology
  • Carrigan Creech from Orthopedic Surgery
  • Cassandra Bowman from Medicine
  • Danielle Kennedy from Oncology
  • Danielle Lanpher from OB/GYN
  • DeAndra Bodiford from Medicine
  • Denise Lech from Surgery
  • Elizabeth Bronson from Oncology
  • Gregory Tipton from Surgery
  • Inneke Johnson from Heart Center
  • Jennifer Andrews from Heart Center
  • Jennifer Ferrara from OB/GYN
  • Jennifer Grant from Population Health Sciences
  • Jessie Ashworth from Heart Center
  • Julie Miller from Population Health Sciences
  • Kimberly Biever from Heart Center
  • Kristi Romero from DOCR
  • Laura Becker from Medicine
  • Lucas David from Oncology
  • Mary Motta from Surgery
  • Meredith Carter from Oncology
  • Michala Ritz from Oncology
  • Nick Chapman from Pediatrics
  • Nikita Shah from CTSI
  • Primula Lane from Oncology
  • Raquel Masegu Pruenca from Oncology
  • Robin Gilliam from Medicine
  • Sankaranarayani Rajangam from Oncology
  • Sarah Gonzales from Population Health Sciences
  • Sarah Sipe from Psychiatry
  • Tedra Porter from Heart Center
  • Tyffany Coleman from Medicine
  • Victoria Johnson from Surgery​
  • Yasmeen Bruton from OB/GYN
Congratulations are in order for the following Clinical Research Coordinators, Clinical Research Nurse Coordinators, and Regulatory Coordinators for their professional advancement to Tier 3.
  • Dana Thompson from Medicine
  • Kristen Bagby from Medicine
  • Leslie Willis from Medicine
  • Linda Brown from Pediatrics
  • Lori Hendrickson from DHVI
  • Yanne Toulgoat-Dubois from Anesthesiology

 

Congratulations are in order for the following Research Program Leaders for their professional advancement to Tier 2.
  • Rachel Kozink from Psychiatry
  • Courtney Frankel from Medicine
  • Donna Crabtree from DOCR
  • Megan Oakes from Population Health Sciences
  • Catherine Foss from Medicine
  • Kevin McKenna from Population Health Sciences

 


Partner Resources

 

DUHS Compliance Office Newsletter

Catch up on news from the DUHS Compliance Quarterly Newsletter.

Subscribe to the Clinical and Translational Science Institute (CTSI) Bi-Weekly Newsletter

Stay up to date on news, funding, and education opportunities in translational science at Duke by subscribing to CTSI UPDATES. Read past newsletters and subscribe at https://www.ctsi.duke.edu/news/newsletters.

 

To be added or removed from the distribution list for the Duke Clinical Research Update, please contact DOCR at docr.help@dm.duke.edu.