Sponsor/CRO Study Application

Site Submission Form (Multi-Center)

Site Submission Form (Additional Study Location)

Site Submission Form (Short Phase IV)

Investigator Delegation Form

Serious Adverse Event/Unanticipated Report Form

Protocol Deviation Form

Site Continuing Review Report

Sponsor Continuing Review Report

Close-Out Report

FDA 1572 Form (if applicable) (external link)

California Bill of Rights

Declaración de Derechos de Participantes en Estudios de Investigaciones Medicas (Spanish translation of Participant’s Bill of Rights for Medical Research)

Investigator Guidebook