Clinical Research Investigator Resources
For several decades, our investigators have been on the leading edge of important innovations and breakthroughs. Our Research Institute team provides comprehensive support as you conduct clinical research.
Explore our resources:
- How to get started guide
- CITI (Collaborative Institutional Training Initiative) certification requirements
- Federal agency resource links
- Human Research Protection Program Policy and Procedure Manual
- Penn Medicine
- Regulatory bodies for clinical research
- REDCap login
- Research Institute fellowship, internship, and volunteer opportunities
- Louise von Hess Grant funding
How to Get Started Guide
Sponsored Studies
Conducting a government-, foundation-, or industry-sponsored study is a great way to engage in research and professional development. It also helps you get to know Institutional Review Board (IRB) processes, research roles and responsibilities, and the life cycle of a study. Sponsor-initiated studies are ideal for researchers who:
- Do not have the bandwidth to develop their own studies
- Have never conducted a research study before
In sponsored studies, the sponsor develops the research idea and study protocol for IRB approval. The sponsor then packages all the necessary documentation for you.
Typically, sponsor-initiated studies follow these steps:
- Sponsors contact the Research Institute with clinical research opportunities.
- We do an initial feasibility analysis. This analysis ensures we have the patient demographic, resources, and interest needed to participate.
- We identify a principal investigator (PI) to partner with the sponsoring organization.
- The PI identifies co-investigators, also called sub-investigators (sub-Is).
Most study investigators start as sub-Is and learn from PIs. They eventually become PIs of their own studies.
Investigator-Initiated Studies
If you have a research idea or are interested in developing one, complete our Research Support Request Form. One of our research project managers will get in touch with you to schedule a meeting to discuss your interest.
In investigator-initiated studies, the investigator develops a research idea, study design, and the documentation required for IRB approval, such as the study protocol and data collection forms. The Research Institute takes an active role in helping you fulfill these responsibilities at every stage—from proposal support, funding, and staffing to enrollment and study publication.
See our investigator-initiated studies guidance to learn more about:
- How we support you through the study life cycle
- Important Human Research Protection Program policies you should know
CITI Certification Requirements
You must complete training through the CITI Program to engage in human subjects research at Penn Medicine Lancaster General Health. The type of CITI training required depends on the type of research you are doing and your role in it.
For questions about CITI training and certification, contact:
Jonathan Derr, MBA, MS
Penn Medicine Lancaster General Health Research Institute
Administrative Director
Jonathan.Derr@pennmedicine.upenn.edu
Federal Agency Resource Links
Food and Drug Administration (FDA)
- FDA's MedWatch (clinically important safety alerts and a place to report of serious problems with human medical products)
- Learn about expanded access and other treatment options (an FDA resource)
National Cancer Institute (NCI)
- National Cancer Institute (federal agency that funds and conducts human cancer research)
- Clinical trials and insurance coverage (an NCI resource guide)
National Institutes of Health (NIH)
- National Institutes of Health (network of federal agencies that fund and conduct human research)
- ClinicalTrials.gov (national database of research studies)
Human Research Protection Program Policy and Procedure Manual
The University of Pennsylvania Human Research Protection Program (HRPP) and Institutional Review Board (IRB) are integral partners of the Research Institute. They ensure compliance and provide oversight of all research activities involving participants at Penn Medicine LG Health.
The Standard Operating Policies outlines the policies and procedures you must follow when conducting human subjects research. It’s important to familiarize yourself with them as you engage in clinical research.
Penn Medicine
We are closely connected with the Office of Clinical Research at the University of Pennsylvania’s Perelman School of Medicine. Because of this partnership, Penn Medicine Lancaster General Health investigators can participate in clinical research happening at Penn Medicine facilities in Philadelphia. This research includes advanced gene therapy, proton therapy, and CAR-T cell therapy trials.
REDCap Login
REDCap (Research Electronic Data Capture) is a tool that helps your research team track and analyze your study’s data. The research team uses it to build secure online databases and surveys. Login to REDCap or request access with the REDCap User Support Form.
Regulatory Bodies for Clinical Research
These regulatory bodies oversee human subjects research:
- FDA
- U.S. Department for Health and Human Services Office for Human Research Protection
- Penn Medicine Lancaster General Hospital IRB
Louise von Hess Grant Funding
The Louise von Hess Research Grant is an internal funding source for physician-directed research at Penn Medicine Lancaster General Health. The funding period is available for use within two years.
Qualifying research should focus on the Lancaster area and involve:
- Education
- Advancement of medicine
- Application of research to medicine
- Improving the health and well-being of our patients
If you have a research idea and would like to pursue von Hess Grant funding, email:
Halle Miller, MPH
Research Project Manager
Penn Medicine Lancaster General Health Research Institute
Halle.Miller@pennmedicine.upenn.edu
Questions?
For general questions about research at Penn Medicine Lancaster General Health, email LGHResearch@pennmedicine.upenn.edu or call 717-544-1777.