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´óÏó´«Ã½ Clinical Research Processes

Human subjects research involving patient data from the ´óÏó´«Ã½ Medicine practice, other data collected at ´óÏó´«Ã½, or data collected by ´óÏó´«Ã½ employees not involving hospital data must be approved by ´óÏó´«Ã½. The principal investigator (PI) must be an ´óÏó´«Ã½-employed faculty member and the PI must sign off on all submissions.

For additional detailed information regarding regulatory compliance, visit the Training and Regulatory Compliance webpage.

Prerequisite Requirements

• CITI Program affiliation with ´óÏó´«Ã½ and completion of courses Biomedical Research Investigators, Information Privacy and Security (IPS), and Responsible Conduct of Research (RCR). CITI certifications are good for three years.
  1. Log on to and affiliate with ´óÏó´«Ã½. (Note: You can see your institutional Courses and affiliations from the My Courses tab.)
  2. Select ´óÏó´«Ã½ Ìý View Courses tab Ìý Complete the following courses:
     • Biomedical Research Investigators
     • Information Privacy and Security (IPS) for Clinicians
     • Responsible Conduct of Research (RCR)

IRB Approval Process

1. Access .
2. From the IRB tab, select Create IRB Protocol
3. Follow the prompts to enter all relevant information.
4. After entering all necessary information, submit the protocol. It will be routed to your department chair for appropriate approval signatures.
5. Revise as required - Receive IRB approval or exempt status.
6. After receiving letter from the IRB, start your study. Study data can now be accessed or received.

Contacts

• ´óÏó´«Ã½ College of Medicine Office of Research
• ´óÏó´«Ã½ Division of Research

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