Office of Clinical Research

• Operations
• Training Required for Clinical Research
• Other Clinical Research Staff

Human Subjects Protections:

Training Resource: CITI Protection of Human Subjects Research Training - ORA
Frequency: Prior to starting clinical research. Initial training must be established, as of April 2019, renewal of CITI training for Human Research is no longer required at Penn. 
Applies to anyone who is: Interacting/intervening with human subjects; obtaining identifiable data/specimens

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Good Clinical Practice:

Training Resource: [Select any one of the following]

1. Completion of on-line, interactive ACRP Good Clinical Practice (GCP) Simulation module
2. Completion of: CITI's GCP eLearning Module [CITI Drugs and Device and Social & Behavioral]
3. Providing documentation of approved, sponsor-required GCP training

Frequency: Prior to starting clinical research and every three years
Applies to anyone who is: Involved in the conduct, oversight, or management of a prospective, interventional clinical trials

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HIPAA Privacy*:

Training Resource: Protecting Patient Information (HIPAA) (UPHS)
Frequency: At start of PSOM employment and every year
Applies to anyone who is: Faculty or staff at PSOM

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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 who is: Anyone whom the Principal Investigator determines is responsible for the design, conduct or reporting of research

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PennChart- Coordinator:

Training Resource: PennChart Training for Research Coordinators
Frequency: Before system use
Applies to anyone who is: Conducting research using hospital services

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PennChart- Research Biller:

Training Resource: PennChart Training for Research Billers
Frequency: Before research billing review can be conducted
Applies to anyone who is: Conducting research billing review 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:

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 required only 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.