Below is a list of information and forms to be included in the Copernicus Group Independent Institutional Review Board (CGIRB) submission packet from the sponsor/contract research organization (CRO), site management organization (SMO), institution, or the principal investigator (PI).
Forms listed below that are available in our forms section are noted in bold italics. Please check with your sponsor contact to determine what you need to submit directly to CGIRB. A review cannot be performed prior to the receipt of all appropriate information.
For Protocol Submissions:
- Submission Letter for CGIRB Review
- Study Protocol (final version)
- Proposed Subject Information and Consent Form and Authorization to Use and Disclose Personal Health Information for Research Template (must be in Microsoft Word format on CD or submitted electronically)
- Clinical Investigator’s Brochure (CIB) or Package Insert
- Proposed advertisement/recruitment material
- Study Application Form
- CGIRB Indemnification Agreement signed by sponsor
For New Investigator Submissions:
- Investigator Site Questionnaire completed for the primary research site that is listed in section three on the 1572
- Investigator Site Questionnaire for Additional Sites completed for any secondary sites listed in section three on the 1572
- Any supporting documents needed to provide information for answers provided on the Site Questionnaires
- Current curriculum vitae (CV) of PI – CVs must verify affiliation to at least one study site and must be current within 2 years
- Sub-investigator CVs are not generally required, but if provided must be current within 2 years. If the PI is not an MD and the study requires an MD, one of the sub-investigators must be an MD.
- Current professional license of PI – If PI is licensed in Massachusetts, a copy of the research license must also be included (Controlled Substance License)
- Proposed site-specific advertisement/recruitment material and site-specific requirements for the subject information and consent form (including any state and/or local requirements that are stricter than the Federal requirements)
- Any additional study-related documentation to be provided to the subject (eg, diaries).
Submit all required information so that it is received at CGIRB by your selected submission deadline. Incomplete packets or packets received after the submission deadline will be placed on a later meeting agenda.
The CGIRB Board sends all original correspondence to the PI. Upon written request, CGIRB will provide a copy of the approval documentation directly to the sponsor, CRO, institution, or SMO managing the study. The PI is responsible for providing documents requested by all other parties. When items have been previously approved by CGIRB (and are not submitted with a New PI submission), it is up to the sponsor/CRO/institution/SMO to provide copies of these approved items to the sites.