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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. Single-Investigator Study Start-up Requirements: - Form 100-D1 – Initial Review Protocol
- Form 110-D2 – Initial Review Investigator
- Form 515 – Conflict of Interest Disclosure
- 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
- Recruitment Material, if applicable
- Study Material (diaries, questionnaires, patient instructions), if applicable
1 For Non-Drug/Non-Device Research use Form 100-ND 2 For Non-Drug/Non-Device Research use Form 110-ND
Multi-Investigator Study, Start-up Requirements: - Form 100-D1 – Initial Review Protocol
- 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
1 For Non-Drug/Non-Device Research use Form 100-ND Additional Investigator Start-up Requirements: - Form 110-D2 – Initial Review Investigator
- Form 515 – Conflict of Interest Disclosure
- Site-Specific Recruitment Material, if applicable
- Site-Specific Study Material (diaries, questionnaires, patient instructions), if applicable
2 For Non-Drug/Non-Device Research use Form 110-ND
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
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or at 512.380.1244.
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Using Our Forms
For your convenience, all of our submission forms are created using Microsoft Word and contain editable text fields which allow you to type directly onto the form. You may also save the form to your computer for completion at a later time.
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