• Skip to primary navigation
  • Skip to main content
  • Skip to footer

Human Research Protection Program

University of Southern CaliforniaResearch and Innovation
  • Getting Started
  • Research
  • HRPP
  • IRB
  • Education & Certification
  • Policies
  • Contact
You are here: Home / Research / Investigator-Initiated Trials

Investigator-Initiated Trials

Most Investigator-Initiated Trials do not have an industry sponsor. With limited resources and less oversight, investigators face challenges in ensuring compliance with regulations and good clinical practices. Below are guidelines and templates on the responsibilities of investigator initiated/ sponsor-investigator research.

  • FDA Guidance for Investigational Drugs (IND)
  • FDA Guidance for Investigational Devices (IDE)
  • Best Practices in Clinical Research Protocol Writing

USC Resources

  • USC Sponsor-Investigator Agreement
  • Regulatory Science Consulting Services

Protocol Templates

  • NIH Clinical Trial Template (Phase 2, 3)
  • Norris Protocol Template
  • Protocol Template (Cooperative Health System)
  • Protocol Writing Tips (Kinetiq)
  • Organizing a Clinical Trial Binder
  • Phase I Trial Design Tips

Guidance from Other Institutions

  • UCSF Investigational New Drug (IND) Submissions for Sponsor-Investigators
  • UCSF Investigational Device Exemption (IDE) Development Process

Footer

HRPP

3720 S. Flower Street, Suite 325
Los Angeles, CA 90089

HRPP@usc.edu
(323) 442-0114

Full Accreditation badge from the Association for the Accreditation of Human Research Protection Programs

About Us

  • Home
  • Announcements
  • Contact
  • Getting Started
  • Education & Certification
  • HRPP
  • Policies
  • Twitter

Research

  • BioIRB Meeting Dates
  • BioIRB Rosters
  • Biomedical Research
  • Biospecimen & Data Repositories
  • Emergency Research
  • Investigational Drugs and Devices
  • Investigator-Initiated Trials
  • Reliance Agreements
  • Requesting USC IRB to Act as the sIRB
  • Requesting USC to Rely on an External IRB
  • SBIRB Meeting Dates
  • SBIRB Roster
  • SBIRB Social Behavioral Research
  • Starting a Research Trial: the Basics
  • Student Researchers

IRB

  • Forms and Templates
  • FWA and IRB Registration Numbers
  • IRB FAQs
  • IRB Review: How to
  • IRB Submission Guidelines
  • Levels of IRB Review
  • Not Human Subjects Research (NHSR)
  • Privacy, Confidentiality, and Anonymity in Human Subjects Research
  • Recruitment Guidance
  • Urgent Review

HRPP
3720 S. Flower Street, Suite 325
Los Angeles, CA 90089
oprs@usc.edu
irb@usc.edu
(323) 442-0114

Full Accreditation badge from the Association for the Accreditation of Human Research Protection Programs
University of Southern California   Content managed by HRPP
  • Privacy Notice - Notice of Non-Discrimination