The IIRB accommodates each sponsor with individualized procedures for protocol submission. We are available for consultation throughout the protocol development process. This includes Informed Consent Form (ICF) development and site specific submission procedures.

Instructions Submission

The following information and site documentation is necessary for site approval

• A brief cover letter requesting review and approval (see FORMS)
• Complete the Site Questionnaire Form (see FORMS).
• Revise template ICF to inlcude site specific information. Pay particular attention to:
  • Page 1 - Investigator/address/phone
  • the payment section
  • Whom to Contact for Answers
• Signed and dated FDA Form 1572.
• Copy of the current CV/License for all individuals listed on the FDA Form 1572.
• Advertisements (if possible), telephone screening forms (if necessary).

Sponsor modifications of the procedures are welcome. Ongoing status reports are provided to sponsors to facilitate communications.