Bridging the Gap Between Human Research Participants, Investigators & Research Sponsors.

Print Page

Protocol Guidelines

Sponsor’s submitting a protocol on behalf of multiple sites should submit the following to Opus IRB:

  • A complete copy of the protocol with all version dates and amendments to date attached
  • IND/IDE number (if applicable)
  • A complete list of all sites participating in the study to include full name of the Principal Investigator, Sub-Investigators, name of institution or practice, contact person at each site along with address, phone number and email contact information
  • The contact information on whom is responsible for the monitoring of the study to include name of organization, project manager name, phone number, and email contact information
  • Investigator Brochure/Manual