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 September, 2020
The following is a message from Dr. Emma Meagher. All questions must be sent to firstname.lastname@example.org
September 22, 2020
The purpose of this message is to provide further guidance regarding resumption of clinical research, in light of the recently revised Research Resumption plan from the University and Penn Medicine’s clinical resurgence activities.
A restricted population density requirement has been removed from the research resumption plan. Additionally, Penn Medicine has resumed all patient care activities. Accordingly, all clinical research that is an extension of medical care is considered essential, including all clinical trials. Clinical research faculty and staff who are required for the optimal and efficient performance of on-site essential clinical research activities are asked to meet those responsibilities on site.
Please note the following caveats:
- All faculty, students and staff must adhere to social distancing and PPE requirements, as laid out in the plan from the Office of the Vice Provost for Research.
- Hybrid ‘in person/ onsite’ work plans should be adopted by teams, where necessary, to maintain social distancing.
- Industry and CRO on site monitoring, auditing, SIVs, etc. may take place on site as long as all vendors meet all of the standard safety precautions and guidelines required for Penn employees. This includes registering and tracking through Penn OpenPass for vendors and contractors on site, https://pennopen.med.upenn.edu/about-for-vendors-contractors.
- Certain activities that can be effectively performed off-site can continue to be done remotely.
- The IRB’s required General Precautions for in Person Engagement with Research Participants’ should be followed.
As a reminder, as you reactivate and start new trials please inform Bob Vonderheide about oncology studies and me for non-oncology studies so that we can maintain an accurate accounting of our clinical research activity during this time.
As you all know, clinical trials are an essential part of the diagnostic and therapeutic options we provide to our patients and as such are mission-critical for Penn Medicine. Your hard work and dedication are crucial and most appreciated.
EmmaVice Dean & Chief Clinical Research Officer, Perelman School of Medicine
University of Pennsylvania
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 in which onsite monitoring must be conducted the monitor may come on-site, provided they are following all Penn policies and procedures around safe return to campus.
- 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 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. On Monday, November 20, 2020, the city of Philadelphia announced new restrictions for businesses and schools. The Commonwealth issued a requirement that those visiting from other states, or returning from other states, are required to have a negative COVID test within 72 hours of returning or quarantine for 10 days. Research staff should check the CDC/ PA state website regularly. https://www.health.pa.gov/topics/disease/coronavirus/Pages/Travelers.aspx Study teams or monitors should be checking this list and website frequently.
- Does the sponsor/ monitor have to register in Vendormate prior in preparation for coming on campus? Yes, please refer to Vendormate section on the OCR page here: https://www.med.upenn.edu/ocr/faq.html Monitors must also use Penn Open Pass daily before coming on campus https://pennopen.med.upenn.edu/about-for-vendors-contractors
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