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: Requirements regarding the execution of clinical research to apply until further notice.
Date: March 16, 2020
Permitted clinical trial activity is limited to essential clinical trials. Essential clinical trials are those that enroll or follow patients with life threatening or serious conditions for which participation in the clinical trial holds out the clear prospect of the patient directly benefiting. Patients already enrolled into clinical trials who are undergoing safety assessments fall into this definition.
No new clinical trials may be initiated at this time unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials or Bob Vonderheide for oncology trials for guidance if you wish to open a new trial.
No new enrollment of research participants into existing clinical trials may occur unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials, or Bob Vonderheide for oncology trials for guidance if you wish to enroll new participants.
In-person research visits should continue for participants already enrolled in essential clinical trials if it is essential for patient safety and/or the participation in the clinical trial is an integral part of the patient’s treatment plan. The study physician, in consultation with the study team, the patient’s physician, the patient, and the patient’s family should carefully assess the necessity and risks of an in-person visit.
All other in-person clinical research visits must be postponed.
Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-ins with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.
Research staff should work remotely, unless their presence is required for the safe conduct of the trial.
Principal Investigators should let commercial sponsors know that opening new ‘non-essential’ clinical trials and enrollment into ongoing ‘non-essential’ clinical trials is temporarily postponed.
Emma A. Meagher, MD
Professor, Medicine and Pharmacology
Vice Dean & Chief Clinical Research Officer, Perelman School of Medicine
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