Office of Clinical Research

• Operations
• Training Required for Clinical Research
• Faculty

Human Subjects Protections:

Training Resource: CITI Human Subjects Protection
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. 

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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) module:
   a. An Introduction to ICH GCP Guidelines
   b. GCP for the Experienced Investigator
2. GCP Opt-Out Exam: GCP Test-Out Challenge: Demonstrate Your Mastery of GCP
3. Completion of: CITI's GCP eLearning Module 
4. Providing documentation of approved, sponsor-required GCP training

Frequency: Prior to starting clinical research and every three years

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HIPAA Privacy*:

Training Resource: HIPAA Foundations and Confidentiality Agreement 2019
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 4 years

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Sponsor Training**:

Training Resource: Investigational New Drug (IND) — Sponsor Training
Frequency: Prior to assuming sponsor responsibilities

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*This training is also required for activities beyond clinical trials or other clinical research.
**This training is required only for faculty who serve in the role of regulatory sponsors of research — i.e., hold an IND, IDE or comparable international regulatory filing.

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.