RCRC can serve as the review board for a Single-Investigator study or as the Central IRB for a Multi-Investigator study. IRB meetings are held twice weekly, Monday and Thursday.

RCRC has implemented a new procedure to further streamline the submission process. RCRC maintains Investigator files, which may now include Form 110.A.  Form 110.A is designed to contain Investigator and the investigative site information that remains consistent from study to study.  Once on file, this form will only require annual renewal and may be used for subsequent research submitted within that year. Please notify RCRC of any changes to the information supplied on Form 110.A as soon as they become known to the Investigator.

The following files remain active with RCRC, once submitted:

• Form 110.A Investigator and Site Information – effective for 1 year from signature date
• Investigator CV – effective for 2 years from the signature date or if no signature, receipt date
• Investigator license – effective until the expiration date
• Investigator training
• Site SOPs - submitted as a part of the application process
• Regulatory audits
• Other attachments, as submitted

Initial Submission Forms for Single-Site Research:

• Initial Review Protocol (FORM 100)
• Supplemental for Drug Research (FORM 100.A), submit as it applies
• Supplemental for Device Research (FORM 100.B), submit as it applies
• Investigator and Site Information (FORM 110.A) – Complete and submit form only if it is not already on file with RCRC
• Protocol Specific Investigator and Site Resources (FORM 110.B)
• For Drug Studies - Investigator’s Brochure or Package Insert
• For Device Studies – Report of Prior Investigations and Device Manual or equivalent
• Draft Informed Consent Document – RCRC provides a Sample ICD template for your convenience, however, its use is not required
• Recruitment Material, if applicable
• Study Material (diaries, questionnaires, patient instructions), if applicable

Initial Submission Forms for Multi-Site Research in which RCRC is serving as the Central IRB:
For Project Managers/Sponsor Representatives

• Initial Review Protocol (FORM 100)
• Supplemental for Drug Research (FORM 100.A), submit as it applies
• Supplemental for Device Research (FORM 100.B), submit as it applies
• Protocol (including any amendments)
• For Drug Studies - Investigator’s Brochure or Package Insert
• For Device Studies – Report of Prior Investigations and Device Manual or equivalent
• Draft Informed Consent Document – RCRC provides a Sample ICD template for your convenience, however, its use is not required.
• Template Recruitment Material, if applicable
• Study Material (diaries, questionnaires, patient instructions), if applicable

For Investigators participating in Multi-Site Research:

• Investigator and Site Information (FORM 110.A) – Complete and submit form only if it is not already on file with RCRC
• Protocol Specific Investigator and Site Resources (FORM 110.B)
• Site-Specific Recruitment Material, if applicable
• Site-Specific Study Material (diaries, questionnaires, patient instructions), if applicable

Submissions may be sent using SafeSync™, our secure online submission system.  We also accept submissions through email, fax, or mail.

For additional information please contact us at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or at 512.380.1244.