Duke Clinical Research Update September 2 2020

Wednesday, September 2, 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

 

Update on Clinical Research Phase 3B

The following memo from Susanna Naggie, MD, Vice Dean for Clinical Research, School of Medicine, was sent to all Duke University School of Medicine Clinical Research Staff and Investigators on September 1st: 

 

Since opening Phase 3A, we have been carefully monitoring COVID cases in Duke employees, including our clinical research employees, and in our local and state communities. During this time, we have also been working carefully with offices across Duke and the Health System to evaluate risks that could be encountered in community-based research and to identify strategies to mitigate those risks.

 

As of September 1, 2020, we will begin a slow opening of Phase 3B, which includes all clinical and human participatory research that occurs outside of Duke and DUHS owned and leased buildings.  This includes research that happens in locations such as participant’s homes, places of worship, businesses, community centers, etc.  Because each location and study has such unique circumstances, we will be requiring CRUs to submit a return to research plan to DOCR, which must be approved prior to resuming in-person study activities.  As usual, study personnel who have not been working in person to-date, will also need to be submitted to DOCR and receive approval from both their CRU and the School of Medicine prior to resuming in-person work.

 

To assist you in thinking through various scenarios and precautions that may present themselves in a community setting, we have developed a new Community Research Return Plan template that has been posted on the DOCR COVID Resource website. Please work with your CRUs to fill out this template.  Plans should be submitted by the CRU RPM or ARPM to this email address: mailto:ReturntoResearch@duke.edu, after which a meeting will be scheduled to discuss the details of your plan prior to approval.

 

Please know that this remains a dynamic situation and worsening of the local and state wide COVID metrics could result in the need to pause research activities again at a later date.

 

I would like to thank all of you for your partnership and care in keeping our staff and participant communities safe. Please contact us at docr.help@dm.duke.edu if you have any questions.

 

Daily Symptom Reporting for Duke Clinical Research Employees Approved to Work On-site

The following applies to Duke Clinical Research Employees approved to work on-site.

 

All Duke clinical research employees approved to work on-site are now required to report symptoms daily (including weekends and holidays, reporting during time off optional) using SymMon, a symptom monitoring application on their iPhone or Android device, or by visiting the REDCap website.  This is a change from the previous policy only requiring you to complete a symptom screen on the days you were coming into work on premises. This change will allow for quicker identification of contact issues and safety procedure problems that Duke will need to address.

 

The symptom monitoring system should be used to report ANY symptoms, even if you think they may be related to allergies or some other issue. For a full list of symptoms, visit the Duke Coronavirus Response website.  If you are unsure, err on the side of caution and report potential coronavirus symptoms. 

 

If you are reporting to work at a Duke Health location you can use the pass in the SymMon app at the front door in the fast-lane for entry rather than the Duke Health Check app.   We encourage employees to utilize SymMon rather than Health Check because it is designed to more readily allow us to identify problems. Please note, while compliance can be tracked, no health data entered into the system will be shared with anyone outside of EOHW.

 

 

Please note that all medical information submitted is kept confidential and supplied directly to Employee Occupational Health & Wellness (EOHW).   

 

Step 1: Completing the Health Profile

 

Note: You are only required to complete the Health Profile form once. If you have already completed a Health Profile, there is no need to re-enroll.  

 

Duke community members should first register and complete the EOHW COVID-19 Health Profile survey in Duke's confidential REDCap system. 

  

To complete the health profile, you will need to provide your NetID and answer a series of health-related questions.  

 

Note: For the optional question, Your Duke Medical Record Number (MRN), provide your medical record number which can be found in Duke MyChart, under Health, then My Info. Otherwise, skip this question.  

 

The system will prompt you to authorize your selections with your signature. Use your mouse or finger to sign your name and then click Save Signature. For additional help filling out the Health Profile, go to: https://youtu.be/jNWSBTqucKs

 

 

Step 2: Submitting Your Daily Symptom Survey 

 

Upon completing the registration, you’ll receive a daily email reminder from Employee Occupational Health and Wellness (EOHW) with a link to submit your symptoms, even on days you do not work. You can report your symptoms through a web browser using the link provided, or via the SymMon mobile app. 

 

For convenience, we encourage employees to use the SymMon mobile app to report daily symptoms. Download it for free from the Apple app store or Google Play.  

 

Then: 

 

  1. Log in with your NetID and password. A screen appears and displays Approval Required for Duke Symptom Monitor. 
  2. Click Authorize. A notification request appears. Select Allow.  
  3. The Symptom Monitoring screen appears indicating Symptom Monitoring Incomplete and displays options for arriving at or leaving Duke. Tap Symptom Monitoring Incomplete
  4. The Record Symptoms screen appears. Follow the prompts to report your symptoms, giving careful thought to each question. The Symptom Monitoring screen will appear and Symptom Monitoring Complete is displayed. 

 

Tracking employee COVID-19 symptoms is one of the ways Duke is working to keep the community safe as it returns to campus this fall.  

 

 If you have any questions please email DOCR at docr.help@dm.duke.edu.

 

Duke Early Phase Clinical Research Unit (DEPRU) transitions from DCRI to DOCR

The Duke early Phase Clinical Research Unit (DEPRU) transitioned from the Duke Clinical Research Institute (DCRI) to the Duke Office of Clinical Research (DOCR) effective July 1, 2020. Our DEPRU leadership and staff remained in place with Jeff Guptill, MD, MA, MHS, FAAN, serving as Faculty Director, Shruti Raja, MD, serving as medical director and Donna Hamel, RCP, MBA, FAARC, FCCM, serving as director of operations.

 

This is a positive change for DEPRU as the move will enable closer operational efficiencies between DEPRU, Duke University Health System, and site-based research operations in the School of Medicine. The transition process began several months ago, and many new processes have been implemented to improve efficiency and provide more flexibility to meet your needs. There are many great synergies between DEPRU and DOCR that truly enhance DEPRU’s capabilities.

 

We at DEPRU are excited about the move to DOCR, and we are committed to providing excellence in our services to you in an efficient manner. 

 

DEPRU became a SOM Service Center

 

During the transition into DOCR, DEPRU was converted to a Duke School of Medicine (SOM) Service Center. This became effective August 1, 2020. This change was more in line with the budgeting needs for site based research.

 

The Duke SOM service centers, formerly referred to as “shared resources”, allows the school to provide needed services and provides a mechanism to capture the cost of providing these services and allocate to users. The recharge rates are based on the actual cost of providing services. Duke Financial Services GAP 200.300, Service Center Administration provides more details. We will schedule a meeting with each study team to confirm the services you would like to utilize and provide an estimate for the service.

 

Temporary changes to DEPRU capabilities in response to COVID-19 

 

In compliance with both the SOM and DUHS, DEPRU has met with the Duke Infection Prevention team which resulted in changes to both the physical space and the functionality of the unit.  These include measures to decrease density, provide adequate social distancing, and allow adequate time for proper cleaning and disinfecting.  These changes include:

  1. Limiting our waiting room availability to 2 persons
  2. Limiting the number of DEPRU staff on the unit to only those essential to be in person thus allowing for more patient/participant space
  3. Staggering visit start times to decrease potential for clustering
  4. Removal of any non-essential furniture and equipment
  5. The discontinued walk tests which are performed in long hallways
  6. Converted our ‘dorm style’ confinement rooms to single occupancy. This decreased our bed space from 30 beds to 9.
  7. Adherence to masking policies
  8. Required COVID -19 negative test results within 3 days of any confinement visit
  9. Proper cleaning and disinfecting of all surfaces between patients/participants

DEPRU is dedicated to meeting the research needs of the Duke community and is doing all that we can to accommodate requests. We ask for your understanding as we are at reduced occupancy, which may result in longer wait times to schedule your study visits. 

 

If you have any questions or concerns, please contact us at: DEPRU-Governance Team

 

Duke University Libraries:  Duke Research Data Repository

Logo for Duke University Libraries and Digital Repository Research Data

 

The Project is Over… What Do I Do with My Data?

Don’t worry – you have options. Whether you need to meet funder requirements or you simply desire to advance the field by contributing your work, there is a data repository out there for your needs. When you choose to publish data in Duke’s Research Data Repository (RDR), your data will be expertly curated by Research Data Management Consultants to ensure it meets FAIR data management principles. Depositors will receive a DOI and data citation for their dataset. The RDR is an open data repository, and does not accept restricted or sensitive data. Read more about the Research Data Repository.

 

Data Drop: A Highlight from the Duke Research Data Repository!

The dataset on COVID-19 facemask efficacy from the related article published in Science Advances is available in the Duke Research Data Repository. Its findings have become a growing topic of discussion, and it has even been featured in the media.

Title: Video data from: Low-cost measurement of facemask efficacy for filtering expelled droplets during speech

Contact: Dr. Martin Fischer

 

 

IRIS/ONCORE UPDATES

 

OnCore:  eReg Signatures for Form 1572

When a document is electronically signed using eReg, the signature is displayed at the end of the document. Documents that require signatures be in a specific location (e.g. 1572) should NOT be signed using eReg. The Managing Contacts for Study Staff in eReg tip sheet has been updated. Forte is developing digital signature functionality to address this issue.

 

OnCore:  Importing Staff to an eReg Binder

Some staff roles available on the iRIS Key Personnel list do NOT transfer to the OnCore staff list and will not be available for import into eReg (e.g. Other, Collaborator or any role with an * in iRIS do not transfer to OnCore). If staff in one of these roles need to sign the DOA, they should be added to the OnCore staff list in the appropriate functional role. The eReg Delegation of Authority tip sheet has been updated to provide further information.

 

 

DOCR NEWS

 

Maestro Care:  Linking Research Encounters and Documenting in the Medical Record

Please remember to link every research encounter, including office visits, labs, diagnostic imaging (CTs, MRIs, Bone Scans, ECHOs) and treatments (chemotherapy, admissions, etc….) to the appropriate research study timeline at the appropriate time point.  If you use Central Grant Scheduling, access limitations may only allow them to link to the research study; not the actual timeline and time point.  In this situation, study teams need to go back to link the research encounter to the timeline and time point.  Linking to the specific time point is extremely important in determining accurate charge routing.

 

Documenting in the medical record is equally important for research encounters and charge review. This documentation, along with other pertinent clinical information, should include: trial name, assigned protocol number (if possible), study visit or time point (C1, D1), today’s date or date of service, study activities completed and reviewed during the visit, brief synopsis of visit, and notation of next research visit with research activities to be completed.  Inclusion of this information in your research note will facilitate accurate and timely review of research charges.

 

Maestro Care: Travel Screening Window (Adapted for Clinical Research Staff) Job Aid Updated

The Travel Screen Job Aid for Clinical Research has been updated to reflect the current Travel Screening questions and list of symptoms in Maestro Care.  You’ll find the revised Job Aid here.

 

 

RECRUITMENT INNOVATION CORNER

Welcome back to enrollment Phase 3a studies!

Logo for Clinical Trials Directory

 

Just a reminder……

As research studies begin to open back up, please remember to make sure your study is listed on the Duke Clinical Trials Directory.  If your study was previously listed on the Directory (pre-COVID shelter-in-place orders), when you change the status from Suspended to Open to Accrual please make sure you check “Display protocol on SIP” box.   If your study is no longer on the Directory after you change your study status to “Open to Accrual,” please Contact the RIC to assist you.  Please note it takes 24 hours for the change to take place on the web site. 

OnCore Digital Display in SIP button

 

 

Something NEW….

The RIC has been working with the COVID-19 Task Force to get many of our COVID-19 trials on the Directory.  This includes inpatient and outpatient trials, repositories, registries, and condition specific studies.  We are also providing Spanish translations for some studies.

Section Visits per Week graph

Since mid-March, we have seen a significant increase in visitors to the Clinical Research Information pages and the Clinical Trials Directory.

 

Google Analytics demonstrate a 200% increase in unique visits to the Clinical Trials Directory since April.

 

If you’re interested, the RIC can tell you how many unique visitors click your study page and what they do when they get there.  In fact, we should congratulate to the Duke Health and Exercise Registry- your page has been visited the most, with the HERO HCQ Trial a distant second!

 

If you have a study that is actively enrolling and it is not listed but you would like it to be, please don’t hesitate to reach out to the Recruitment Innovation Center!  We can be reached at studyrecruitment@dm.duke.edu or at 919-681-5698.

 

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!

Follow us on Facebook at Discover Duke Research.

 

 

 

 

TRAINING OPPORTUNITIES

New Training Module: Regulatory Closeout Basics for Clinical Research

Regulatory Study Closeout Basics for Clinical Research

 

This new DOCR course is available in the LMS and takes about 15 minutes to complete.

  

This module is designed to provide study teams with fundamental guidance around regulatory closeout. Topics include: closeout procedures according to DOCR policy, how to properly store study documents after study closure, and re-opening a closed study.

 

The course provides guidance to help develop a baseline in the following WE-R clinical research competency: Site and Study Management: Study Closeout 

 

Link to course

 

Updated Training Module:  Responsibilities of Principal Investigators Conducting Research at Duke Health - DOCR

This updated online module will walk you through the expectations and requirements to serve in the role of Principal Investigator in Human Subjects Research at Duke Health.

 

By the end of this module, you will:

  • Recognize the responsibilities of the DUHS Principal Investigator
  • Recognize the requirements of the DUHS Principal Investigator agreement and know where to find it
  • Recall the Duke specific required training for those serving in the Principal Investigator role
  • Recognize Duke offices and resources available to Principal Investigators and know whom to contact for assistance

Link to LMS module:  https://lms.duhs.duke.edu/Saba/Web/Cloud/goto/OfferingDetails?offeringId=dowbt000000000043087

 

Urine Pregnancy Screening for Research and Phlebotomy Competency for Research

DEPRU has recently joined DOCR.  As we work to realign various functions within DOCR, the Urine Pregnancy Screening for Research and Phlebotomy Competency for Research training classes will transition to DEPRU staff.  Rhonda Rogers and Lynn Jordan will teach the Urine Pregnancy Screening classes and dispense urine pregnancy kits ordered through DOCR.  Meg Stewart, Sten Harris, Victoria Sutton and Dylan Grewen will teach Phlebotomy Competency for Research.  If you have questions about Urine Pregnancy Screening or Phlebotomy training please submit them to DOCR.Help@dm.duke.edu and we will ensure that your message gets to the right person. 

 

Orders for Urine Pregnancy kits are made via REDCap survey via this link:  https://redcap.duke.edu/redcap/surveys/?s=EKNJ7K3EAL

 

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.

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