Duke Clinical Research Update July 15 2020

Wednesday, July 15, 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, 1 PM, via WebEx

 

PACE Office Hours

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

 

RESEARCH COMMUNITY NEWS

 

Clinical Research: Phase 3 critical updates

Phase 3 re-opening has been paused until further notice.

This includes all Tier 2 and Tier 3 internally funded studies and all studies occurring off of Duke premises. This means that staff and faculty who had been approved to return on-site in preparation for Phase 3 studies that were pending approval, will no longer be returning to work on-site. CRU’s should communicate with these personnel regarding this change in plans immediately. We will provide regular updates to CRU leadership regarding the status of Phase 3.

 

All Tier 1 studies and all Tier 2 or 3 studies that re-opened as part of Phase 1 and Phase 2, and studies granted exceptions, will continue to remain open. All sponsor visits should be done remotely whenever possible, however, as of June 30 in-person visits may occur if necessary. Plans for on-site monitoring visits should be submitted following the guidelines on the DOCR COVID resource webpage and await approval before scheduling. Plans for studies that meet requirements for Phase 1 and 2 can continue to be submitted for approval. Please note that no additional employees will be approved to return on site at this time.

 

I’m not receiving my daily EOHW symptom screening survey, what do I do?

If you have been approved to return to work on campus, you will need to complete a daily Employee Occupational Health & Wellness (EOHW) symptom screening survey.  The EOHW symptom screener must be completed every day before physically coming in to work.  Note that you only need to fill out the symptom screener survey on days when you will be coming to campus to work in person. 

 

Employees who are working 100% remotely do not need to register for the daily symptom screener.

 

If you are required to fill out the EOHW Daily Symptom Screening Survey, see the work flow below to ensure you are receiving these surveys and that you are able to complete them prior to coming in to work.

 

If you have been approved to return to campus and have never received EOHW surveys:

 

  1. Contact your ARPM/RPM to make sure that you and your studies are in the approved plans for returning to in-person work.
  2. If you and your studies are in the approved plans for returning to in-person work and you have not received an EOHW survey, contact DOCR (docr.help@dm.duke.edu) to make sure that you were submitted as returning personnel.
  3. If you have confirmed your return to work with both of the above groups and have still not received an EOHW Return to Work Survey, contact EOHW (684-3136, option 2) and ask for a COVID team member for help with symptom survey links

 

If you received the EOHW survey in the past and are no longer receiving them or have any other issues with the survey:

 

  • Contact EOHW (684-3136, option 2) and ask for a COVID team member for help with symptom survey links

 

If an employee knows or suspects that they have been in contact with someone who is COVID positive, they should call the EOHW hotline (919-385-0429) and discuss the potential exposure and next steps with Employee Health.  Such exposures would not otherwise be captured on the daily symptom survey. This should be done prior to coming in to work.

 

Students in Research Labs

This guidance regarding undergraduates in research was provided by the University administration, and posted in the FAQs on the University’s Student and Postdoc Guidance page.  Note the dates included in the guidance.

 

Additionally, students should be included in return to research plans.  Student names and emails should be submitted to the corresponding CRU to be included on the return to research plan so that the students can receive School of Medicine approval to work on-site for their study activities.

 

Q:  Can my paid/work-study undergraduate students return to clinical or laboratory research?

A:  After August 17, 2020, in-person independent study will be allowed for juniors and seniors in research that can accommodate undergraduates under the current clinical research or laboratory reopening plan.  To work onsite, undergraduate students must adhere to Duke’s Guide for Returning to the Workplace and the General Principles implemented by the PI’s school; details regarding each school’s principles can be found at the following links (A&S researchers should contact their departmental chairs for details):  NSOEPratt, and SOM. Lab reopening plans and schedules should be modified as needed to accommodate the addition of student employees, with special consideration paid to any additional oversight or training needs. 

 

Q: Can I accept undergraduate students for independent study?

A: After August 17, 2020, in-person independent study will be allowed for juniors and seniors in clinical laboratories that can accommodate undergraduates under the current laboratory reopening plan. This may require revision of the plan and lab schedule, and consideration should be paid to any additional oversight or training needs. To work onsite, undergraduate students must adhere to Duke’s Guide for Returning to the Workplace and the General Principles implemented by the PI’s school; details regarding each school’s principles can be found at the following links (A&S researchers should contact their departmental chairs for details):  NSOEPratt, and SOM. No restrictions exist for remote independent study, however, please ensure that the proposed research plan meets the guidelines for independent study for the home department of the student.

 

Q: Can graduate and medical students perform On-site clinical research?

A: Yes, graduate and medical students are currently permitted to work on-site for clinical research project.  They should follow the same rules as staff and only be on-site for the study activities that requires them to be on-site and not for any administrative or data analysis activities that can be done remotely.  They must follow Duke’s standard policies regarding student participation in research as posted on the IRB website.

 

Duke Health Update on Recommended Eye Protection

The Centers for Disease Control and Prevention (CDC) now recommends that healthcare workers caring for asymptomatic patients in areas of moderate to high community transmission wear eye protection in addition to face masks. Eye protection is most important when caring for patients who are unmasked.

 

RECOMMENDED EYE PROTECTION FAQS (new)

This document provides answers to frequently asked questions regarding recent recommendations regarding eye protection for healthcare workers.

 

MyChart Research Recruitment

Did you know that over 700,000 MyChart research recruitment messages have been sent to patients at Duke?  These messages are sent by DOCR Maestro Care analysts to invite patients to learn more about studies for which they might be a match.  Patients are able to indicate their interest in learning more, decline participation, or begin an e-consent and/or virtual study workflow directly from the message. Please note that MyChart research recruitment messages must be sent via the centralized process managed by DOCR Maestro Care Analysts in coordination with the IRB and Recruitment Innovation Center. To learn more about this process and associated costs, please complete the intake form at https://redcap.duke.edu/redcap/surveys/?s=EKNJ7K3EAL.

 

Research Ethics and COVID-19: Lessons Learned and Future Considerations

Join us on August 18 for this one day online conference, which will address lessons learned and future considerations around COVID-19’s effect on the human subjects research enterprise including:

  • Vaccine research 
  • Biobanking
  • Informed consent
  • Re-opening research
  • Preparing your HRPP for post-pandemic era
  • Vulnerability
  • And more!

 

Attendees of this program can earn up to 17.5 of CE credit (if they watch all sessions live or on demand).

 

Certified IRB Professionals (CIPs®) can earn up to 17.5 credits in category two (online training and webinars) for participating in online meetings.

Learn More and Register

 

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

 

iRIS Safety Committee Review Outcome Modification

Beginning July 17th, a new Review Outcome will display for Safety Committees entitled, ‘IBC-Approved.’  This outcome is to be used exclusively by the Institutional Biosafety Committee.  All other committees are to continue to use the standard ‘Approved’ review outcome when appropriate.  There is no impact to the study team as the Protocol Status is not impacted by this change.

This is a screen shot of the iRIS application Review Outcome tab.

 

Selecting Key Study Personnel Modifications

To better assist study teams with the selection of key personnel roles that are necessary for the sync into OnCore, we have included additional information within the pick-list when users are making their selections during study creation.  The following roles that will not cross the API and therefore have been denoted with an asterisk within the selection list can be seen in the picture below.  Users are encouraged to continue using these roles as needed, but do note they will not appear on your study in OnCore automatically and will need to be manually added for those KP.

This is a screen shot of the iRIS application showing the Add Personnel role screen.

 

Additionally, we have discontinued the three roles pictured below in OnCore.  These roles will continue to display within the drop-down list as there are users currently listed on these roles and therefore we cannot hide or remove them from iRIS.  Please Do Not Use these roles when making your KSP selections.

This is a screen shot of the iRIS application showing the Add Personnel Role window.

 

DOCR NEWS

 

Society for Clinical Research Sites (SCRS)

Did you know that once you have joined the Society for Clinical Research Sites (SCRS) with your free Duke affiliated membership, you then have access to a number of Site Management Modules?

 

The modules available describe basic concepts of clinical research in accordance with the ICH Guideline for Good Clinical Practice: Consolidated Guidance (E6).

 

Topics include:

  • Principal Investigator Oversight Informational Program
  • Adverse Events and Safety
  • Clinical Research Overview
  • Clinical Practice vs Clinical Research
  • Conducting a Study
  • IRB/IEC Responsibilities and Informed Consent
  • Delegation and Training
  • And many more!

 

To access these modules, create your Duke affiliated account at the SCRS website https://myscrs.org/  and then go to the Learning Campus, Site Management Modules tab.

 

 

RECRUITMENT INNOVATION CORNER

OnCore Study Information Portal News

BREAKING NEWS: Google Analytics demonstrate a 200% increase in unique visits to the Clinical Trials Directory since March!

 

The Recruitment Innovation Center is introducing a new way to post your studies on the Duke Clinical Trials Directory.  Previously, if you wanted your study posted on the Directory you filled out the Study Information Portal Console (SIP) in OnCore and notified the RIC via email.  However, configuration of the SIP console is now closed to study teams effective July 1, 2020.

 

The new process for study teams to publish your study to the Clinical Trials Directory is detailed in this Tip Sheet and below:

  • The RIC has created a SIP Content Worksheet you can temporarily download from Box (it will be moved to the DOCR resources site soon).
  • Study teams will continue to answer the following questions in the worksheet:
    • What is the condition being studied?
    • What is involved?
    • What is the purpose of the study?
    • Who can participate in the study?
  • The study team will submit the completed worksheet to the RIC via studyrecruitment@dm.duke.edu (please follow the file naming instructions in the Worksheet)
  • The RIC will review and edit the content using “tracked changes” and return the document to the submitter for additional review
  • Study team will review RICs edits and either
  • Accept them and alert the RIC that they are acceptable, OR
  • Provide additional edits in “tracked changes” and send back to the RIC for further review
  • Once the study team and RIC agree on the content, the RIC will configure the content in the SIP Console and release the study to the directory.
  • The following day (OnCore updates overnight) the RIC is responsible for ensuring the study has moved over to the clinical studies directory (if the study has a status of “Open to Accrual.”)

 

In other news – We are now allowing study teams to include a hyperlink to an IRB-approved website, prescreener or econsent in your SIP content!

 

Coming in September 2020, we will be allowing select studies to post on the Directory even if they are not actively enrolling.  If your study is paused (e.g., suspended or on hold) but you still want it promoted on the directory Contact the RIC. We will review these requests on a case-by-case basis. Stay tuned for another announcement in September about these changes.

 

If you have a study that is actively enrolling and do not have it listed, but would like it to be, please don’t hesitate to reach out to the RIC to list it!  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!

 

 

Engagement, Recruitment, & Retention Certificate Program: Nominations Open

A new competency-based curriculum and certificate program

 

The Clinical and Translational Science Institute’s Recruitment Innovation Center has collaborated with DOCR to gather a team of experts across Duke and beyond to create a certificate program focused on engaging, recruiting, and retaining clinical research participants. 

Watch this informational video

The purpose of the program is to develop experts in these topics who can serve as a resource in clinical research units and divisions at Duke. Those who complete the program in its entirety will receive a Duke Recruitment, Engagement, and Retention certificate and are encouraged to use that certificate ad a career development tool to enhance applications for Tier Advancement. ​

 

The curriculum also features:

  • A diversity and inclusion lens throughout
  • Expert instruction in timely and requested topics
  • Engaging and thought-provoking material and interactions
  • Wiki access for continuous resource sharing among the cohort
  • CEU credit hours for SOCRA and ACRP certifications
  • And an opportunity to evaluate the program and provide feedback to enhance it for future attendees

 

The program consists of five core classes and two electives. Participants will choose from six elective options. Anyone participating in the program can anticipate approximately 15 hours of commitment associated with the program over a 6 month period. No more than two classes will be held each month from September 2020 – February 2021. The tentative course schedule is available on our program flyer. ​

 

Managers are invited to nominate employees who perform participant engagement, recruitment and retention activities whom they believe additional training would make them good resource in their units. If you are an employee who is interested in the program, please consult with your manager for nomination. ​

Nomination Form

 

All nominations are due by August 3, 2020

Want more information? Check out the program website.​

 

 

The team facilitating this new curriculum will be collecting data to measure program effectiveness. Managers and participants will be asked to complete self and manager-scored assessments both before and after program completion to help with this effort. Students will also be asked to assess the instructors and course content to ensure continuous improvement of the program.​

 

Please direct any questions to Jamie Roberts (Jamie.roberts@duke.edu) and Jessica Cranfill (Jessica.cranfill@duke.edu). ​

 

 

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 School of Nursing CRU welcomes Cherie Barnes, joining DUSON as a Dietician in July. 

 

 

PARTNER RESOURCES

DUHS Compliance Office

Catch up on news from the DUHS Compliance Office.

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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