Welcome to the Office of Clinical Research
Clinical Research Conduct at Penn Medicine Related to COVID-19
This is a rapidly evolving situation and we will provide updated guidance and information as it becomes available.
- NEW March 23, 2020: NIH information and guidance: Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding. Includes information from the NIH on Human Subjects & Clinical Trials:
- FDA Issues Guidance for Conducting Clinical Trials: Coronavirus (COVID-19) Update
- Most recent Press Announcements from the FDA
IMPORTANT MESSAGE: Research Resumption
As of June 8, 2020, Penn will be in Phase I of Research Resumption
The following is an excerpt from the Perelman School of Medicine’s Research Resumption plan. Read and download the plan HERE (https://research.upenn.edu/wp-content/uploads/PSOM-Resumption-052820.pdf)
As we plan for the gradual return to campus, all faculty, students, and staff are expected to comply fully with existing policies and procedures, including those outlined in this document. We emphasize the need for each person’s help locally to ensure we are doing things as safely and as carefully as we can, making sure absolutely that we remain at or below 20% density in any given area during the initial ramp-up of research activities, with the exception of areas focused on COVID-19 research. The 20% density must account for all people on the floor/in the building, including housekeeping, facilities, and animal care staff.
On May 20, the University approved initiation of Phase I (of three phases) Research Resumption on June 1, 2020.
During the voluntary phases of ramping up, all Principal Investigators (PIs) with wet bench research programs must complete an individual lab resumption plan. Upon approval first by the department chair and/or center/institute director (in particular, the relevant leadership who manages the space for the respective laboratory/program should approve the request), the plan and the approval should be provided to the Executive Vice Dean and Chief Scientific Officer (EVD/CSO).
This plan will be accessed via a personalized link that you will receive via email and will address some of the following:
- All students, staff, and post-docs returning to work on-site are doing so voluntarily;
- The plan includes detailed logistics regarding social distancing;
- The plan includes provision of personal protective equipment for all working on-site;
- The plan is coordinated with and approved by department/center/institute leadership, and is incorporated in that entity’s plan for 20% density; and
- The plan follows all current University and School guidance for resumption of research activities
Upon approval of the lab resumption plan by the department chair and/or center/institute director, the PI or Lab Safety Coordinator must complete the Resumption of Research Notification web form (https://ehrs.upenn.edu/covid-19/resumption-research-notification) on the EHRS website. At any time, the decision to ramp down again may be necessary due to any number of factors, including a surge in new cases, changes to the 'stay at home' rules, etc. A return to ramp down phase will be implemented in accordance with the terms of this document.
VISIT THE OFFICE OF THE VICE PROVOST FOR RESEARCH FOR THE COMPLETE UNIVERSITY GUIDANCE: https://research.upenn.edu/resources/resumption/
Frequently Asked Questions (FAQs):
This list will be updated in a real-time, ongoing basis for the duration of Research Resumption
QUESTION: My study falls into Phase 1 of research resumption. I am unsure what is needed in order for an NIH funded study that falls into Category B to be permitted to conduct an on-site monitoring visit.
- Note that each Penn Medicine location may have a different set of requirements, especially if these are patient areas. Please work with your Department or locations front desk personnel to confirm what may be needed of people walking in through the door before confirming and scheduling your monitor visit.
- Explain to monitor that Penn is trying to limit staff and patient occupancy to 20% so while monitors may come on site, it should only be to review items that cannot be done remotely. Create a list with the monitor of the items they are going to need to look at specifically. For example, maybe just signed consent forms and pharmacy records
- EMR and data management systems for source data verification should be accessed remotely.
- Plan where the monitor will be so there is appropriate 6ft of social distancing. Make a plan as to how the CRC and the monitor will meet to discuss findings adhering to social distancing guidelines.
- The monitor should check in at designated check-in spaces and should be registered in Vendormate.
- Check in space for our office is Stellar Chance. This is where there will be a temp screening but not active testing. Do you know the check in space for your department?
- The monitor is expected to have not traveled to another site in the past 14 days. If they have, they cannot come on site.
- If they are coming into clinical space front desk staff are set up screening questions.
QUESTION: I have an industry sponsor with the following questions. How do I respond to these?
- Is onsite monitoring visit permitted by state per local regulations within the next 2 weeks? Yes, for trials that have been categorized by Penn as being allowed to restart while we are 20% capacity for research
- Is onsite monitoring visit permitted by your site within the next 2 weeks? Yes
- Please confirm the following:
a. Will there be a dedicated room for CRAs to monitor where no patients are seen/tested? Depends on the department/ Research team to answer this question.
b. Will there be enough space in the room to accommodate social distancing (If more than 2 CRAs monitors your site at the same time)? Depends on the department/ Research team to answer this question.
c. Please let me know how your process for reviewing queries/conversations with your site during the monitoring visit. Specifics must be provided by the department/ Research team. Any meeting space between the two parties will need to abide by the 6 ft distance.
- Does your site have PPE (Personal Protective Equipment)? No. The monitor should plan to supply their own mask.
- Does your site require COVID-19 testing prior to accessing the facility? No.
- Does your site require COVID-19 questionnaire to be completed prior to entering facility? Yes, the CRC and/ or front desk staff depending on location will ask a series of questions.
- Does your site require a temperature screen prior to accessing the facility? Yes, per guidelines for a safe return to campus.
- Does your site have EMR? IF so, would your site provide access to the CRA? If so, what would be your requirements? Yes, also allows for remote monitoring. Please see the SOP below for more information. https://www.med.upenn.edu/ocrobjects/secure//library/SOPs/SOP_406_External_Monitor_Access.pdf
Please confirm that your site does not require a quarantine prior to going from site to site. The expectation to come on site will be that the monitor has not traveled to another institutions, or anywhere in the past 2 weeks, other than to come to Penn.
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