Office of Clinical Research

• Operations
• Training Required for Clinical Research
• Clinical Research Coordinator and Clinical Research Project Manager

Clinical Research Onboarding Training: Includes Human Subjects Protection, GCP, HIPAA* and Clinical Research Certification

Training Resource: Penn Clinical Research (CR) Onboarding - OCR
Frequency: Within 2 weeks of hire into CRC/CRPM role and prior to starting clinical research; Clinical Research Certification should be completed within one year of hire.
Refresher training of Human Subjects Protection, GCP and CR Certification is required every three years and for HIPAA every year
Applies to: All CRCs and CRPMs (other research staff performing CRC functions related to human subjects research)

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HIPAA Privacy*:

Training Resource: Protecting Patient Information (HIPAA) (UPHS)
Frequency: At start of PSOM employment and every year

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Conflict of Interest*

Training Resource: Financial Conflict of Interest in Research Investigator Training Course
Frequency: At start of employment at Penn; prior to engaging in research and every four years
Applies to: Anyone whom the Principal Investigator determines is responsible for the design, conduct or reporting of research. Training requirement is based on PI determination only.

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PennChart- Coordinator:

Training Resource: PennChart Training for Research Coordinators
Frequency: Before system use
Applies to: Any CRC or CRPM working on studies in PennChart

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PennChart- Research Biller:

Training Resource: PennChart Training for Research Billers
Frequency: Before research billing review can be conducted
Applies to: Any CRC or CRPM involved in research review of billable services in PennChart

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PennCTMS:

Training Resource: PennCTMS Training 
Frequency: Before system use
Applies to anyone who is: Designated by his or her department to serve in a role requiring PennCTMS training— e.g., registering studies or managing subjects in PennCTMS.

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Sponsor:

Training Resource: Investigational New Drug (IND) — Sponsor Training
Frequency: Prior to serving in sponsor representative role
Applies to anyone who is: Qualified to serve and designated by a sponsor  to serve as a sponsor representative

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*This training is also required for activities beyond clinical trials or other clinical research.

Note: When using completion of training from another institution you will need to provide the original completion certificate and a detailed description of content covered in the course.  Certificates must have date of completion listed in order to be used to satisfy training.