Inspected by the FDA. No deviations from applicable federal regulations (no 483 issued).

Forms:

Initial Study Submission Forms

  • Guidelines for Submission Packet  | 

    Identify standard procedures for review services

  • Study Application Form  | 

    Provides the basic agreement for review services

  • Satellite Site Application Form  | 

    Provides the service agreement for study satellite sites

  • Indemnification Agreement  | 

  • Investigator Statement  | 

    Needed when a FDA form 1572 is not required

  • Shipping & Invoice Form  | 

    Specifies delivery and billing information

  • Financial Disclosure Form  | 

    Investigator Financial Disclosure Form


Continuing Review Forms

  • Quarterly Review Report  | 

  • Annual Review Report  | 

  • Final Review Report  | 

  • Unanticipated Event Form  |