Duke Clinical Research Update March 18 2020

Wednesday, March 18, 2020
Logo for Clinical Research Update Newsletter from the Duke Office of Clinical Research (DOCR)

 

 

 

 

 

 

 

 

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, 1 PM, via WebEx

 

PACE Office Hours

Every other Tuesday, 1 PM, via WebEx.  Click for information.

 

RESEARCH COMMUNITY NEWS

 

Suspension of Non-Essential In-Person Clinical Research Study Activities and Change in Duke Health Visitor Policy as Part of Clinical Research COVID-19 Response

 

As you are aware, the Duke University, Duke Health and Duke School of Medicine response to the COVID-19 pandemic is changing rapidly. We are appreciative of the level of engagement and responsiveness we have received from all of you as we navigate this challenging and disruptive time together.  

 

 

  • On Monday March 16, the Duke School of Medicine Clinical Research Administration will initiate the Essential Clinical Research Study Policy. At that time, all in-person study activities for non-essential studies will be temporarily suspended until further notice.  While other research activities that can be done virtually or remotely will be able to continue, participant in-person visits will not be allowed.

 

For essential studies, we ask that research activities be converted to virtual or remote/tele visits as much as possible. Unless, direct engagement of a participant is needed to maintain integrity of the study and health of the participant (e.g. consent, investigational product delivery, or laboratory testing), we ask that all other visits be done remotely. Below we have provided the most up-to-date definitions and guidance on essential and non-essential research definitions.

Please review the IRB Policy titled “COVID-19 and Research at Duke” released on March 11, 2020 for further guidance on changes to research activities related to COVID-19. Please also reference the research.duke.edu FAQ list for questions regarding sponsor interactions and effort considerations related to this suspension of non-essential in-person study activities.

 

  • Starting Monday March 16, hospitals and clinics will begin operating with restrictions in place to protect against the spread of COVID-19. Patients will be allowed one person over the age of 12 with them to any appointment or hospital visit. All patients and visitors will be screened for symptoms of illness upon entry to Duke Health. If a visitor is found to have symptoms related to COVID-19, flu or a cold, they will be given information about what to do and asked to return home to help prevent the potential spread of illness.

 

Thus, for research participants this restriction of only one allowed visitor over the age of 12 to attend the research visit will also apply. Duke Health patients will be receiving notification of this new visitor screening policy. Research participants that are not Duke Health patients will not receive this communication, thus research staff will need to contact non-Duke Health Patient Participants to make them aware of this new policy before coming for their research visit. Please continue to complete the Maestro Care Travel Screener Tool Aid (or paper screener tool for non-Duke patient participants) for all essential study research participants on arrival to the research visit.

 

  • Starting Monday March 16, for all essential studies with planned in person research visits that will not take place on Duke Health premises (hospital or clinic), participants should be called in advance for over the phone pre-screening. If a participant screens positive for symptoms or reports a high risk contact or travel, the research visit should be deferred and the participant should be instructed to call their PCP office or local health department. If the participant screens negative, they should be instructed to call the research team immediately if they develop symptoms before the in-person research visit the next day.

Please feel free to contact susanna.naggie@duke.edu for Clinical Research related questions.

 

What defines an essential clinical research study?

While we do not have a known prior definition of essential studies, we are currently defining an essential study as any study utilizing drugs, biologics, or devices that holds the prospect of direct benefit to the participant. Furthermore, any study involving therapeutic radiation would be considered essential. We are asking PI and CRUs to assess studies meeting this definition to identify those they believe must continue with in-person study activities due to the health and well-being of the participant. All other studies would be considered non-essential. 

 

What defines a non-essential clinical research study?

Non-essential studies are primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies. Non-essential studies may also be interventional studies that are not viewed as so critical to the health and well-being of the participant that it is worth the risk to the research staff and Duke Health community. If a PI or CRU believes a non-essential study needs to continue with in-person study activities, they will need to request this permission from Susanna Naggie and Adrian Hernandez. We must balance benefit to participants with risk to our research staff and the Duke Health community.

 

 

Research Operations and COVID-19 – Frequently Asked Questions

As we confront the challenge of trying to contain the spread of COVID-19, we need your leadership and support to curtail the number of individuals on the Duke campus and in Duke facilities. 

 

For all university faculty and staff, we ask you to cease small-group and individual meetings effective immediately, transition to remote access for these activities, and follow the guidance for social distancing whenever on campus.

 

We recognize that many of our colleagues have detailed questions about how the new policies will affect research at Duke. These questions include the actual research process, as well as allowable charges to Federal grants. We have prepared a number of frequently asked questions and answers (FAQs) to address concerns.

 

This website will be the source for guidance about research activity at Duke while we are in this period of great uncertainty.  The FAQs will be continually updated as we receive more information from our Federal sponsors and can analyze new regulations connected to COVID-19.  This information expands on the university policies that have been put in place regarding travel, events, and visitors to Duke.  I also encourage you to check https://coronavirus.duke.edu on a regular basis for updates.

 

Safety within our research laboratories is our highest priority.  Please note that all Duke safety policies remain in place. Care should be taken to align laboratory safety practices with efforts to reduce the risk of exposure to COVID-19. For example, it is essential to ensure adequate staffing to respond to emergencies.

 

We have mobilized a team of experts at Duke to help our faculty, students, and staff understand how the new work environment impacts performing research. Please let us know if there are additional matters not covered in the FAQs via the contact methods at the bottom of the FAQ website. These are challenging times, but we are focused on giving Duke researchers all the tools and information needed to continue our research endeavors.

 

COVID-19 and Research

The DUHS IRB has issued a statement regarding COVID-19 and Research.  This notice includes information regarding:

Mandatory Screening for COVID-19 Exposure
Deferral of On-Site Research Monitoring Visits
Preparation for Potential Study Holds/Revision of Study Activities
Sponsor/Funding Notifications
IRB Approval
COVID-19 Research Studies
IRB Operations
Contact Information

Because information and processes involving the outbreak are quickly evolving, please monitor the Duke COVID-19 Resource page and expect further notifications from Duke Health, Duke University, DUSOM, and/or the DUHS IRB.

 

How to Bookmark the COVID-19 FAQ in the myRESEARCHhome myLinks Widget

From the myLinks Widget in myRESEARCHhome, select the Add Link button at the bottom of the widget.

This image shows the myLinks Widget in myRESEARCHhome

 

In the Name Field type:  COVID-19 Research FAQ

 

In the URL Field Copy and Paste:  https://research.duke.edu/coronavirus-research-FAQ

 

Click Save

This image shows the name field and URL field in the myRESEARCHhome my Links widget

 

This will add the COVID-19 Research FAQ to the Favorites section of the myLinks myRESEARCHhome widget.

 

 

 

Duke External Monitoring Policy for External Distribution to Sponsors

The Duke External Monitoring policy has been posted to the DOCR website.

 

This policy can be downloaded from the DOCR website and distributed to external sponsors in regard to external monitoring, SIVs, etc. in response to the COVID-19 epidemic.

 

Monitor visits at Duke should be postponed until after April 20, 2020.

 

As new information becomes available regarding the COVID-19 response, this policy may be updated and/or the visitor restriction lifted.

 

 

Logging into Duke Research Systems Using VPN

Access to Duke Systems While Working Remotely:

Duke Health is working to increase internet bandwidth and VPN capacity in order to cover the internet demand while employees are working at Duke and at home.  In order for everyone to be able to have access to the systems they need when they need them, we are asking that you limit your VPN and Citrix access to the time periods you are actively working in the system.  We also ask that you turn off your Video feature in your virtual meetings (i.e.: Web-Ex) unless you absolutely need the video feature for your work.  Limiting videos during these meeting will also help with internet connectivity. 

 

Accessing Maestro Care While Working Remotely:

To access Maestro Care while working remotely, you will need to access the Duke Citrix application via the Web by visiting citrix.duke.edu.  Please review the attached Duke Citrix Remote Access tip sheet for instructions.

 

If you are having trouble accessing Duke Citrix at home, please review the following article for additional troubleshooting steps: Click HERE

 

Accessing OnCore While Working Remotely:

To access OnCore while working remotely, you will need to connect through the Duke Health Virtual Private Network (VPN) before accessing.

 

If you are having trouble accessing the Duke Health VPN, please review the following article for additional troubleshooting steps: Click HERE

 

Multi Factor Authentication:

Multi Factor Authentication (MFA) is required in order to access Duke Citrix and Duke VPN.  Please visit the Duke Office of Information Technology’s MFA page for information on establishing MFA with Duke’s VPN.  DUO push is one of the easiest and fastest ways to complete the required MFA steps.  Please visit HERE if you would like to establish MFA with DUO Push. The website has tips for Android and iOS phones, and includes videos for demonstration of DUO Push.

 

Reminder:

Duke Health Information Technology Security Office (ISO) has approved Web-Ex to be used with research participants if video conferencing is needed, however, no sessions involving PHI should be recorded within the tool and PHI should not be put in the chat channel. Please do not use Zoom or any other video conferencing application when contacting research participants.

 

Phlebotomy Competency for Research Study Personnel Policy Updated

The Phlebotomy Competency for Research Study Personnel Policy was recently updated.

This policy defines the training requirements and skills necessary for research study personnel to perform venipuncture/phlebotomy for the purposes of collecting research blood samples, for biomedical research activities, that are either stored, sent to an outside lab or processed by DUHS labs and are entirely paid by research funds.

This policy applies to research study personnel in one of the 12 clinical research professional job classifications.

Policy highlights include:

  • Research personnel not in a CRU must have approval from Oversight Organization (OO) leadership prior to enrolling in the Phlebotomy Competency for Research training course
  • Research study personnel are not permitted to draw clinical standard of care labs. CRU research study personnel are not DUHS employees and therefore, not permitted to perform clinical services.
  • In the event that a study participant requires both a blood draw for research and clinical care labs simultaneously, the labs must be drawn by DUHS phlebotomy personnel who are employed by DUHS. This is often referred to as a “piggyback” blood draw workflow.
  • Documentation of research phlebotomy competency will include ten (10) successful venipunctures completed under the supervision of an individual who is clinically competent to draw blood according to DUHS standards.  This will be the Point of Contact (POC) Nurse identified in each CRU. If a CRU does not have a POC Nurse, DOCR’s Nurse and/or the POC Nurses in any CRU can observe and document. Point of Contact (POC) Nurse:  A School of Medicine designated nurse who acts as a point of contact for a Clinical Research Unit.
  • Each CRU will create a CRU SOP for research only blood draws and study teams are required to follow their respective CRU SOP for research only blood draw workflows.

Read the policy in its entirety on the DOCR Website.

 

Resident/Fellow Transitions

With the approach of summer, many residents and fellows who are currently conducting research at Duke will be transitioning away from Duke.  It is important to remind any Residents and Fellows who will be leaving Duke in the summer to complete their research activities or to work with their CRU to make arrangements to continue their research after leaving Duke.

 

eGRC Update Slated for March 31st

The DHTS Information Security Office Compliance team will be performing a minor version upgrade to the eGRC application on March 31st, 2020.  Users of the Policy/Exceptions/DTIF/RDSP modules will see an upgrade to the user interface but no changes in functionality.  If you have any problems after the upgrade, please contact the DHTS service desk at 919-684-2243.

 

Clinical Research Training Program Accepting Applications

The program is now accepting applications for academic year 2020-2021. For a detailed description of the program, the course offerings, and a link to the online application, please visit the CRTP website at http://crtp.duke.edu.

 

This year CRTP is launching the Basic Science Research Track (BSRT), a customized curriculum designed for physician scientists and trainees leading to a Master of Health Sciences in Clinical Research Degree. 

 

The application deadline for priority review is May 15, 2020. Applications will be accepted through August 1, 2020.

 

 

IRIS/ONCORE UPDATES

 

OnCore Financials and the Subject Visit Update Screen

With the implementation of OnCore Financials, one of the following must be completed for all procedures in the Procedure section of the Subject Visit Update screen:

  • Procedure Date entered
  • Missed checked
  • N/A checked

If none of the above is completed, OnCore assumes that the procedure(s) has been done and the procedure(s) will show on the Financials Console which results in inaccurate billing to the Sponsor.

This image shows the Subject Visit Update screen in OnCore

 

Tip sheets are available on the DOCR OnCore Support Page (https://medschool.duke.edu/research/clinical-and-translational-research/duke-office-clinical-research/clinical-research-resources-and-applications/oncore-training-support-page).

 

 

OnCore:  New Tip Sheet Available—Updating Calendar Versions

A new OnCore Tip Sheet, Updating Calendar Versions, has been posted to the DOCR website.  This tip sheet will walk end users through the process of changing calendar versions in OnCore with step by step instructions and screen shots.

 

iRIS FAQ:  My study team member has completed all of their CITI training, but I do not see their name on the KSP pick list.  What is going on here?

A study team member’s name will not appear in the iRIS system until they have logged into the iRIS system for the first time (regardless of their CITI training completion status). 

To have a study team member’s name appear on the iRIS Key Personnel pick list, they must log into the iRIS system using their Duke Net ID and password.  This initial login will create and iRIS account for the study team member and their name will appear on the Key Personnel pick list.

Logging in for the first time will also map the person’s CITI training into the iRIS system.  If for some reason the training does not map, submit a Service Now ticket to have their CITI training manually mapped to iRIS.

 

 

DOCR NEWS

 

WE-R:  Tier Advancement Credit

As part of Tier Advancement for CRCs, CRNCs, and Regulatory Coordinators, we are now giving credit to those staff members who have been certified through ACRP or SOCRA. Staff will receive two points for being certified through ACRP or SOCRA and uploading documentation of said certification during their next Tier Advancement cycle. In addition, staff may receive an additional two points for maintaining their certification for at least one certification renewal cycle (refer to ACRP and SOCRA guidelines for this). Staff may receive a max of four points throughout Tier Advancement. An FAQ has been posted to the WE-R website. If you have additional questions, please email wer-jobs@duke.edu.

 

Note: Please do not submit to Tier Advancement just to add these points.

 

REDCap Hits 9000 Projects

We have created 9000 projects in REDCap. The growth continues as faculty, staff, and students are using it to collect their research data securely.

This image shows the REDCap logo

 

REDCap is a HIPAA compliant, secure web application for building and managing online surveys and databases. Learn more about by watching a brief video.

 

REDCap can be accessed at https://redcap.duke.edu and a practice project can be requested here.

 

Contact redcap-docr@duke.edu for a Demo.

 

REDCap and eConsent

With many teams switching to eConsent, please see the updated eConsent instructions.

 

Contact us with any questions at redcap-docr@duke.edu or join us during virtual office hours (see below).

 

REDCap Support Office Hours Move to Virtual Sessions

All in-person weekly office hours sessions are being replaced with virtual sessions.

Email redcap-docr@duke.edu to indicate which of the following times you would like a DOCR team member to schedule a WebEx with you.

 

  • Tuesdays, 10 AM – 11 AM
  • Wednesdays 10 AM – 11 AM
  • Thursdays, 2 PM – 3 PM
  • Fridays 10 AM - 11 AM

 

Weekly office hours can also be found on REDCap’s home page.

 

Notice of REDCap Downtime

REDCap will be offline between 5:00 PM and 10:00 PM on Wednesday, March 18th while we upgrade to v9.5.

REDCap v9.5 will have all the core functionality from our current version plus many new features and improvements. You can review a full list of these here.

 

 

DHTS has scheduled 5 hour server maintenance windows that will affect REDCap accessibility.

These are scheduled for the following times:

  • 3/20/2020 10:00 PM
  • 3/27/2020 10:00 PM
  • 3/28/2020 10:00 PM
  • 4/03/2020 10:00 PM

 

DOCR Transitions Research Wednesdays Series and DOCR Instructor-led Classes to Virtual Format

Due to ongoing developments with COVID-19, the Duke Office of Clinical Research will be transitioning the Research Wednesdays series and the DOCR Instructor-led course calendar to a virtual format effective immediately.

  • Research Wednesdays will move to a WebEx format.  WebEx meeting information will be sent to the DOCR list serve the Monday prior to the session.  Viewers can receive JA credit for the session and track viewing of the session in the Ethos System by texting the JA credit code posted at the start of the session.  Instructions for creating an Ethos account can be found at the bottom of the Research Wednesdays session announcement and on the DOCR website.
  • DOCR Instructor led classes will either be offered via WebEx or postponed at the discretion of the course instructor.  If you are registered for a DOCR Instructor led course, be on the lookout for communication regarding the status of your class.

 

Research Professionals Network (RPN):  April Event Postponed to Fall

The April RPN event on the topic of “Implicit Bias” will be postponed to the fall.

 

In the meantime, keep up to date with the latest RPN happenings by visiting the RPN page on the DOCR website.

 

 

RECRUITMENT INNOVATION CORNER

 

Returning Value to Research Participants

 

This is a graphic showing the relationship of giving and receiving with circular arrows

When a person decides to participate in a research study, it is a fundamental expression of their generosity.  They are giving study teams their implicit trust with the belief that their participation is essential for a course of research that may not ever affect their lives.  For this, we need to thank them!

 

How can we do this?  It’s called returning value by returning results.  When participants feel valued they are more likely to:

  • Complete a study
  • Participate in future trials
  • Engage family/friends to participate
  • Become a research advocate

This graphic shows a letter being handed from one person to another

It’s ethically necessary and vitally important to make sure participants are informed of aggregate study results, believe their participation is respected and appreciated, and understand the value of their contribution to advancing science and improving public health. 

There are tools to create infographics and newsletters. Reach out to the Center for Data and Visualization Sciences to obtain their help displaying your study data in a visually appealing format.

The Recruitment Innovation Center is also happy to help your team with the content and plain language that should be used to return the results of your study.  Please Contact Us to help your team share the results (no matter how small!) to your participants and to keep them coming back!

 

 

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 Population Health Sciences CRU welcomes Debra Henke and Erin Daniell, CRS SRs, to the Center for Health Measurement. 
  • The Dermatology and Pathology CRU welcomes Kristy Averette as the new Research Practice Manager.

 

 

 

PARTNER RESOURCES

 

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

This image shows the corner of a building on Duke West Campus

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