COVID-19 Updates for Clinical Research
Research Resumption plans for Clinical Research can be accessed through the Office of the Vice Provost for Research. Click Here to be redirected.
Clinical Research Conduct at Penn Medicine Related to COVID-19
Important links from the NIH and FDA on COVID-19 Human Subjects Research:
- 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
Frequently Asked Questions (FAQs) on research conduct during COVID-19 pandemic: Effective since September 2020
This list will be updated in a real-time, ongoing basis for the duration of Research Resumption. We are currently at Phase III, Full Research Operations
QUESTION: Can our research team enroll unvaccinated research participants that need to travel by airplane to Philadelphia?
RESPONSE: At this time, consistent with the Health System Policy around outpatient practices and patients, we are not requiring that research participants be vaccinated. This applies for both local participants and those traveling. We want to be careful to not bias research results by not including unvaccinated individuals or make it seem as though one must be vaccinated to participate in research.
If it makes sense for a research protocol to exclude unvaccinated individuals that needs to be part of the IRB approved protocol. Also adding any requirements around testing should be included in the protocol. Screening for symptoms, however, is common practice and mask wearing is required.
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
- 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.
- 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.
- 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 and mask wearing.
- 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 for monitors, 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 the sponsor representatives/ monitors do not require a quarantine prior to going from site to site. As of March 1, 2021 the Order of the Secretary of the Pennsylvania Department of Health for Mitigation Relating To Travel is no longer in effect. Travelers should still practice appropriate public health measures to slow the spread of COVID-19 such as masking, physical distancing, and hand hygiene.
Research staff should check the CDC/ PA state website regularly. https://www.health.pa.gov/topics/disease/coronavirus/Pages/Travelers.aspx
- Does the sponsor representative/ 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 Proof of COVID-19 vaccination is also required. They must also use Penn Open Pass daily before coming on campus https://pennopen.med.upenn.edu/about-for-vendors-contractors
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