Welcome to the Office of 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:


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

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.

RESPONSE:

  1. 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.
  2. 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
    1. EMR and data management systems for source data verification should be accessed remotely.
  3. 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.
  4. The monitor should check in at designated check-in spaces and should be registered in Vendormate.
  5. 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?
  6. 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March 1, 2021 the Order of the Secretary of the Pennsylvania Department of Health for Mitigation Relating To Travel is no longer in effect.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

  7. 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?

RESPONSE:

  1.  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.
  2. Is onsite monitoring visit permitted by your site within the next 2 weeks? Yes
  3. 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.

  1. Does your site have PPE (Personal Protective Equipment)?   No. The monitor should plan to supply their own mask.
  2. Does your site require COVID-19 testing prior to accessing the facility?  No.
  1. 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.
  2. Does your site require a temperature screen prior to accessing the facility?  Yes, per guidelines for a safe return to campus.
  3. 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
  4. Please confirm that the sponsor/ monitor does 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

  5. 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