Below is a list of information and forms to be included in the IRB submission packet. Please check with your Institution's IRB Liaison or contact us directly to determine what you need to submit to CGIRB. A review cannot be performed prior to the receipt of all appropriate information. Submission information may be emailed, faxed, shipped or submitted securely online directly to Copernicus Group IRB.

FOR PROTOCOL SUBMISSIONS:

• Submission Letter requesting IRB Review
• Study Protocol
• Proposed Subject Information and Consent Form (including any site specific information, hardcopy and diskette or CDROM)
• Clinical Investigator Brochure or Package Insert
• Proposed Advertisement/Recruitment Material (if available)
• Shipping and Invoicing Information Form
• Indemnification Agreement (when applicable)
• IRB Authorization Agreement Form

FOR NEW INVESTIGATOR SUBMISSIONS:

• Investigator Site Questionnaire
• Curriculum vitae (CV) of Principal Investigator and all Subinvestigator(s). (CVs must verify affiliation to at least one study site, must be current within 2 years and signed and dated by the Investigators.)
• Current Professional License of Principal Investigator
• Proposed Advertisement/Recruitment Material
• Copy of Form FDA 1572 (if applicable)

All CGIRB forms are available online in PDF and Word Fillable format for your convenience. If submitting a hardcopy submission, collect all requested information and forward to the following address so that it is received by the IRB by your selected submission deadline. Incomplete packets or packets received after the submission deadline will be placed on a later meeting agenda.

Copernicus Group IRB
One Triangle Drive, Suite 100
P.O. Box 110605
Research Triangle Park, NC 27709
Attention: Project Team
irb@cgirb.com

The Board will send all original correspondence to the Principal Investigator. Upon written request, Copernicus Group IRB will provide a copy of the approval documentation directly to the Institution's IRB Liaison managing the study. The Principal Investigator will be responsible for providing documents requested by all other parties.

Download a copy of our Brochure.