General

What can I do to prepare? 
Connect with your CRU and divisional leadership to verify your specific plans for triaging and managing study participants. Familiarize yourself with the triage and management plan on the COVID-19 resource page. Put relevant infection prevention phone numbers into your phone now so you will have them when and if you need them. 

  • For Duke University Hospital, please page 919-970-9721 

  • For Duke Regional Hospital, please page 919-470-4636 #7171 

  • For Duke Raleigh Hospital, please page 919-206-3311 

  • For Duke Primary Care and Urgent Care, please call 919-896-2428 

  • For Private Diagnostic Clinics, please call 919-451-8828 

  • Durham County Health Department, please call 919-560-7600 

  • NC Department of Public Health Communicable Disease Branch 24/7 Hotline, please call 919-733-3419 

  • Duke Hospital Incident Command Center at 919-684-2222 


I am sick, how do I record my time off?
If you are sick, please follow EOHW guidelines.  Additional information on recording your sick time can be found here [link to Kyle’s page].


I can’t access the research building where I need to work.
As of April 13, laboratory building access has been restricted to personnel who have been identified as requiring access for essential research duties. Anyone requesting access to a laboratory building must submit the Lab Access Request Form for departmental approval. Approvals are vetted through departmental leadership in collaboration with the Office of the Vice Dean of Basic Sciences and the DUHS Command Center. For clinical research staff and faculty, please send forms to stephanie.freel@duke.edu. This will begin the process of gathering the reqired approvals.

**Anyone who will be entering the hospital or clinic spaces must first enter through the main hospital or clinic entrance to be screened and may not enter clinical spaces through CARL or any other access point for the first time that day.**


I have study staff who can’t do their research activities at this time, is there a way to move their effort onto another project at Duke during the time when we are required to work remotely?
Yes, first, talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) to see if there are studies within your unit that may need extra effort.  Second, the Duke Office of Clinical Research (DOCR) is helping to coordinate shared effort across the School of Medicine during this time. You can submit an Available Effort Form to let them know the amount of available effort, potential duration, and technical skills.  They will work with you to find a match with studies that need extra staffing if one is available.


I have studies that need extra staff, is there a way to find research staff who may have extra time available because their assigned research activities have slowed?
Yes, first, talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) to see if there are staff within your unit who have available effort.  Second, the Duke Office of Clinical Research (DOCR) is helping to coordinate shared effort across the School of Medicine during this time. You can submit a Request for Staff Effort form to let them know the amount of effort needed, potential duration, and technical skills required.  They will work with you to find a match with staff who have available effort.


I am a student and I want to help with COVID-19 clinical research, how can I find a study to work on? 
Duke School of Medicine graduate and medical students who are interested in helping with COVID-19 clinical research studies are invited to submit a volunteer application using the link below. Please note that there may be a great need for assistance with a variety of clinical research projects at this time, and some opportunities may be more scholarly (e.g., helping with grant applications) or may be on studies other than COVID-19 studies. All opportunities will be limited to activities that can be conducted remotely (virtually). 

The COVID-19 research task force will consider volunteer applications to find matches with appropriate research opportunities. Once you complete an application, someone will reach out to you to discuss. In addition to capturing your information, this survey will let the team know what kind of training you may need to complete before starting research activities for a particular study, so we thank you for filling out the form completely.  Student Research Volunteer form 


I have a new COVID study starting.  How do I enlist medical or graduate student volunteers to help?
Talk with your Research Practice Manager (RPM) or Assistant Research Practice Manager (ARPM) about your needs.  They can guide you through the requirements of involving various types of students in your research as well as discuss with you oversight of the students clinical research activities.  A request for medical and graduate students who have volunteered to help with COVID research (Student Research Collaborative), can be requested using the Student Request Form. Please note these students may only assist with virtual and remote study activities at this time.


We have a study team that completes home visits. Is the current plan only applicable to research patients/participants that come to Duke? 
The current screening recommendations include all research participants with whom you will have in-person visits, regardless of location. We have provided triage plans for DUHS and non-DUHS participants and for participants on and off Duke premises. Please see above.  


My study has international sites. Do we still need to screen participants at international sites? 
At this time, Duke does not require screening at international sites. We recognize the difficulty in creating an implementation plan in countries where contacts, policies, and resources may be different or unknown.  We ask Principal Investigators to consider the relative risk to their research staff and research participants at these sites and to devise a plan that best ensures safety.  When possible, our travel aid screening tool may be used and supplemented with local procedures and contact numbers. 


How can I stay informed on the latest updates regarding COVID-19? 
Information will be regularly updated on Duke Health’s COVID-19 Information Resource page (COVID-19 Info Page) and on DOCR’s website (DOCR Website). All critical changes will be communicated from the SOM to all faculty and staff via email. Furthermore, Dr. Naggie, DOCR, and CRU leadership will meet weekly to ensure information is disseminated to research teams. For Clinical Research related questions, including COVID-19 specific protocols, please contact Dr. Susanna Naggie. A recording of the March 12th town hall is available on the DOCR website and here, please note that some of the information discussed in that town hall is already out of date. This FAQ website is being updated regularly and contains the most up-to-date information. 


Will visitor restrictions be placed on friends or family who accompany research participants during their research visit? 
Yes. Visitor restrictions are regularly updated on the DUHS COVID-19 page. Starting Monday, March 23, Patients will not be allowed visitors with them to any appointment or hospital visit except in specific instances as described in this visitor communication; this restriction will also apply to research visits. 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. 

While Duke Health patients will be receiving notification of this new visitor 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 research participants on arrival to the research visit. 


My research is FDA regulated. How is the FDA responding to the COVID-19 outbreak, and what should I do to make sure my studies are documented appropriately if research activities have? 
The FDA has issued updated guidance for industry sponsors and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. This updated document includes several FAQs including guidance on obtaining signed informed consent from COVID-19 patients in isolation. Notable indications are below. 

For all trials that are impacted by the COVID-19 pandemic, sponsors should describe in appropriate sections of the clinical study report (or in a separate study-specific document): 

  1. Contingency measures implemented to manage study conduct during the disruption of the study as a result of COVID-19 control measures.
     
  2. A listing of all participants affected by the COVID-19 related study disruption by unique subject number identifier and by investigational site, and a description of how the individual’s participation was altered.
     
  3. Analyses and corresponding discussions that address the impact of implemented contingency measures (e.g., trial participant discontinuation from investigational product and/or study, alternative procedures used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the study. 

While Duke has issued specific recommendations regarding IRB amendments (link to memo), study teams should document in-house all protocol and operational changes for future use and reference. 


Are there guidelines that protect at-risk staff? 
The CDC currently identifies the following as people at higher risk for severe illness: Older adults, people with HIV, people with asthma, and pregnant women. 

At this point, Duke has not placed any restrictions on specific staff. What is most important for your protection is that any patient/participant be screened for symptoms and risk and when the screen is positive, immediate measures are followed for infection prevention including deferring visits for patients who are not already present, and for patients who are present for a clinic visit, following triage processes as described above. 

If you are within one of the CDC-defined risk categories, please discuss with your manager options for working remotely or other options for protecting yourself from exposure. 


I have students working on my human research study.  Can they continue their research?  
Undergraduate students, whether paid or unpaid, may only continue research activities remotely. They may not continue research on Duke campus or in DUHS spaces.  

As of March 17, Duke University School of Medicine has suspended all of the required clinical clerkships (MD and PA) and third-year medical student clinic experiences. Graduate and medical students should continue their research remotely whenever possible. Graduate students and postdoctoral researchers are partners in our research activities and may voluntarily agree to be designed as key/essential individuals. However, it is unacceptable for them to be pressured into this role or designated without consultation. Any trainee uncomfortable with performing an essential role as assigned by their faculty mentor should immediately contact their school/center/institute research leadership. Please review new recommendations and requirements related to students and postdocs doing research on the FAQ site here