The submission deadline is THURSDAY, 12:00 NOON (CT) - Early Submissions are Greatly Appreciated. All study-related documents and attachments must be received at noon for your submission to be considered complete.

Initial Submission Forms and Guidance Documents
FORM 100 Initial Review (Protocol) (Adobe Acrobat file, 270 Kb)
FORM 105 Guidance Document: Initial Review (Protocol) (Adobe Acrobat file, 83.2 Kb)
FORM 110 Initial Review (Investigator) (Adobe Acrobat file, 403 Kb)
FORM 115 Guidance Document: Initial Review (Investigator) (Adobe Acrobat file, 113Kb)
FORM 515 Financial Disclosure and Conflict of Interest, Principal Investigator and Research Staff (Adobe Acrobat file, 51.7 Kb)

Informed Consent Document Information
FORM 650 Informed Consent Document Template (Drug) (Microsoft Word file, 121 Kb)
FORM 660 Informed Consent Document Template (Device) (Microsoft Word file, 119 Kb)
FORM 630 Guidance Document Writing an Informed Consent Document (Adobe Acrobat file, 58.2 Kb)

Continuing Review Submission Form and Guidance Document
FORM 120 Continuing Review Report (Adobe Acrobat file, 231 Kb)
FORM 125 Guidance Document: Continuing Review Report (Adobe Acrobat file, 80.6 Kb)

Final Report Submission Form and Guidance Document
FORM 130 Final Report (Adobe Acrobat file, 136 Kb)
FORM 135 Guidance Document: Final Report (Adobe Acrobat file, 44.3 Kb)

Changes to the Site or Principal Investigator Submission Forms and Guidance Documents
FORM 140 Additional Site/Site Change (Adobe Acrobat file, 96.8 Kb)
FORM 145 Guidance Document: Additional Site/Site Change (Adobe Acrobat file, 49.2 Kb)
FORM 150 Principal Investigator Change (Adobe Acrobat file, 145 Kb)
FORM 155 Guidance Document: Principal Investigator Change (Adobe Acrobat file, 48.6 Kb)

Unanticipated Problems Submission Form and Guidance Document
FORM 300 Unanticipated Problems (Adobe Acrobat file, 53.7 Kb)
FORM 310 Guidance Document: Unanticipated Problems (Adobe Acrobat file, 53.1 Kb)

Additional Guidance Documents
FORM 600 Guidance Document: Reporting Responsibilities (Adobe Acrobat file, 34.5 Kb)
FORM 610 Guidance Document: Recruitment and Study Material (Adobe Acrobat file, 34.6 Kb)
FORM 620 Guidance Document: Research Participant Information (Adobe Acrobat file, 32 Kb)
FORM 620 Guidance Document: Research Participant Information (Spanish) (Adobe Acrobat file, 33.3 Kb)
FORM 640 Guidance Document: Administering Informed Consent (Adobe Acrobat file, 60.2 Kb)