Clinical Research Training
Training is an essential aspect of clinical research at the University of Pennsylvania. Clinical research personnel require different levels of training to complete necessary tasks.
Listed below are the basic trainings needed to navigate clinical research here at Penn.
Penn CR: Onboarding Program
Training for all clinical research personnel has been designed by the Office of Clinical Research (OCR) to provide a comprehensive training and education program for Penn research staff whose primary role is conducting human subjects research.
Penn CR: Onboarding Program (required)
- The Penn CR: Onboarding Program is required training for all Clinical Research staff within 6 months of hire date. Review the Office of Clinical Research required training web page on earning your certificate.
Penn CR: Certification Program (optional)
- The Penn CR: Certification Program is for continuing education which OCR offers helpful materials for earning this certification.
For more information about these training programs, visit the OCR website.
Collaborative Institutional Training Initiative (CITI) Training
The University of Pennsylvania policy requires all personnel engaged in human research, including faculty, research fellows, students, and staff, to have appropriate training in human research protections.
To satisfy this requirement, the university requires all personnel to complete the CITI web-based training program.
CITI training is valid for a 3 year time period and must be renewed by completing a web-based CITI Refresher 101 course.
Instructions for fulfilling the CITI training requirements can be accessed via the IRB website.
Clinical Research Workshops
The Office of Clinical Research offers workshops each month to provide information and/or updates on a variety of topics relevant to individuals working in human subjects’ research. The topics address a vast array of study operational and compliance issues.
The Institutional Review Board (IRB) also offers training opportunities throughout the year on topics related to use of HS-ERA system, human subjects research regulations, writing a consent form, and other topics pertinent to those working on the regulatory aspects of human subject research.
All training can be viewed in Knowledgelink.
Clinical Trial Management System
The Enterprise Penn CTMS Project
Clinical Research at Penn will soon be transferring over to a Clinical Trials Management System (CTMS). CTMS is a software system designed to help principal investigators, study coordinators, and other faculty and staff track and report on nearly every aspect of a clinical trial.
The Penn CTMS is a long-term effort to evolve how clinical research is conducted. The project has multiple phases, with the first phase expected to last through the end of 2017.
All research staff working on studies that utilize Health System clinical applications (Epic, MedView, Sunrise Clinical Manager, etc.) must receive training before they can access the electronic applications.
All new research coordinators or current research coordinators who will need access to Epic must complete the PennChart Research Workflow-OCR course. Registration for the course can be completed through KnowledgeLink. Search the term ‘PennChart Research Workflow’ to find upcoming course offerings.
Topics covered include:
- Subject registration
- Maintaining the enrollment record
- Attaching a research guarantor number
- Navigating the EMR
- Placing research orders
- Research billing reconciliation
All Credentialed Research Coordination staff (RNs, NPs) requiring the ability to place and SIGN orders must complete the following course in addition to the PennChart Research Workflow – OCR Course:
All training can be viewed in KnowledgeLink.
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