Welcome to the Office of Clinical Research
Clinical Research Navigation Assistance
If you need assistance with a clinical trial — anything from budget development through study close out — please complete our new Clinical Research Navigation Assistance form.
News-At-A-Glance (Highlighting Clinical Researchers at Penn)
Starting in January 2019, please hold FIRST MONDAYS 12-1PM for the new RESEARCH ETHICS AND POLICY SERIES (REPS). The goal of the series is to focus on emerging issues in research ethics and policy, in order to draw attention to these topics, provide a forum to discuss them with experts and trainees, and facilitate connections between those working in research ethics to promote collaboration across Penn and CHOP.
Potential topics may include:
- Right to Try and Expanded Access
- Research in emergency settings
- Return of research results
- Data sharing
- Bystander risks in research
- Paying research participants
- Broad consent to future research
- Ethical issues in biobanking
- Engaging patient research partners for diseases like Alzheimer’s
- Informed consent under the revised Common Rule
- Research with terminally ill patients
- Nudging research participation
- Research with prisoners
We will circulate a list of speakers and their topics in the coming months, as well as the central meeting location. The format will include both lectures and panels, with at least half the time reserved for discussion.
Contact Holly Fernandez Lynch, JD, MBE, Assistant Professor of Medical Ethics, Department of Medical Ethics and Health Policy
AAMC Webinar on Technology Transfer Basics for Academic Medical Centers
This hour-long webinar will describe the basics of technology transfer as it applies to academic medical centers. Concepts such as invention disclosures; patents; licensing; and revenue sharing will be defined. The following ideas will also be explored:
- What are the reasons that universities would want to participate in technology transfer activities?
- How do academic institutions measure success in technology transfer?
- What are the benefits of university technology transfer efforts?
Former Executive Director of the Office of Licensing Technology
Date: September 14th, 2018
Time: 1:00pm — 2:00pm (eastern)
New Question in Penn Profiler - Impacts to GCP Training
A new question has been added to Penn Profiler which is intended to capture, and assign training, to faculty and staff who are involved in the conduct of a clinical trial. The question asks, "Are you involved in the conduct, oversight or management of a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes? This includes both interventional clinical trials and behavioral health interventional studies"
For those who answer affirmatively, Good Clinical Practice (GCP) training will be signed via Knowledge Link (KL) in accordance with the Standard Operating Procedures (SOP) unless training has already been completed. GCP training is required, and must be refreshed, every 3 years for those involved in the conduct of a clinical trial.
Detailed information can be found under “Training Required for Clinical Research”
Clinical Trials Radio Blog
"Beating Leukemia with Groundbreaking CAR-T Cell Therapy"
Background: The CAR-T technique involves removing a patient's T cells and inserting new genetic material that enables the T cells to attack and kill cancer cells. The modified cells are then infused back into the patient's body following chemotherapy to fight the remaining tumors. The new approach is the result of pioneering research by Drs. Grupp, June and their colleagues and has the potential to help patients with other types of cancer, including brain, lung, ovary, pancreas, prostate and breast cancers.
Read more about Dr. Stephan Grupp, MD, PhD here and Emily Whitehead’s story here
Questions? Please contact the Office of Clinical Research (OCR) at email@example.com or 215-662-4484. Please feel free to forward this information.
- PSOM Research Consent Guidance Memo
- Additional Guidance Regarding Consenting Subjects in Interventional Studies
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