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: Phased return to clinical research activities
Date: May 11, 2020
Dear Clinical Research Staff,
Please read the attached document that outlines the considerations for a phased return to clinical research. While we wait for direction on the timing of when this may occur from the State, City, University and PSOM, I am sharing this plan with you so that you can start to plan with your teams. This may also give you an opportunity to ask questions in advance.
As clinical care activities begin to increase, there is a natural inclination to want to reactivate suspended clinical research activities. Recognizing that, please remember that until the “shelter in place” restrictions are reduced, only the following types of clinical research activity are permissible at this time.
- Essential Clinical Trials include the following
- New and existing clinical trials that hold the clear prospect of benefit for patients with life threatening or serious conditions
- In-person study visits required to assess safety of patients who were enrolled in clinical trials prior to the pandemic
- New and existing clinical trials where enrollment into the trial is the only available option for the patient
- COVID Clinical Research
- As clinical service lines begin the “resurgence” to clinical practice; new and existing clinical trials and non-interventional clinical research where the research activities that must occur on site can occur during inpatient stays and during patients’ already scheduled clinical visits and those same research activities can be executed; without requiring that clinical research support staff return to campus. PIs must confirm that imaging, IDS, CHPS, CVPF and all other research specific services have essential staff on site and are available to execute the trial.
- Research that can be conducted remotely should continue to be conducted remotely with all staff working remotely. This includes:
- Trials where in person visits can be eliminated or conducted remotely via telemedicine and investigational meds can be delivered to the participants’ home
- Non interventional research where research participants do not need to come on campus, research staff can effectively execute the research activities remotely and direct contact with participants is not required.
Please remember: PIs and CRCs conducting ‘Essential Clinical Trials’ and ‘COVID Research’ work (# 1 and 2 above) are considered essential employees and are required to work on-site and adhere to all requirements to reduce likelihood of infection of staff and research participants. Research staff involved in # 3 above, monitoring, auditing, training, SIVs, research systems support, financial management, contracting, and regulatory support activities are not permitted to return to campus at this time. Clinical research participants are not permitted on campus unless they are a participant in an approved essential trial, a COVID research study or they are on campus for clinical care reasons as in-patients or outpatients.
If you have questions related to oncology research activities please work with Bob Vonderheide. Otherwise feel free to route your questions to me.
Emma A. Meagher, MD
Professor, Medicine and Pharmacology
Vice Dean & Chief Clinical Research Officer, Perelman School of Medicine
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