APPLICATION CHECKLIST Initial Application by goc91510


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									                                                                  APPLICATION CHECKLIST
                                                                                      Initial Application
                                                                               Expedited and Full Board

                                                                                           Form 4.10 – 4/10/09

Electronic Submissions: Send all materials by e-mail to Identify each
      attachment with a common name (e.g., company or study number). Send consent form in
Paper Submissions: Send one original and one copy of all of the study materials to 100 Tamal
      Plaza, Suite 158, Corte Madera, CA 94925

BUSINESSS (1 original – Separate from protocol as it goes to the business office)
        Check, purchase order or request for invoice
        Indemnification form for this submission (4.50 A or B) or contract (please call)
        Information about your organization – Brochure or website or description

        4.12 (A – C) Application Cover Form - Identifies the study and its important points.

            Cover Form Supplements – to be included as appropriate:
             4.13 Study review                           4.16 Special Population Forms
                 A Expedited Review Request                  A Employees,
                 B Investigational Device                    B Pregnant Women,
                 C Investigational Drug                      C Prisoners,
                 D Radiation                                 D Children

      Any item included must be identified by version number and/or date for ease of tracking.
            A cover letter from the submitting client - if explanation of some point is needed.
            Protocol (detailing the research aspects, for help see web at 3.2.9)
            Consent Document(s), Infomation Sheet or           Application for consent waiver (4.25)
            Recruitment Materials: ads, screening scripts
            Case Report Forms, surveys, interview outline
            Anything else considered to be part of the protocol

         4.20(A-C) Principal Investigator Application Form and
             Curriculum Vitae current date & signature    Performance site (for each site)
             Current professional license, if any             Study site facility description or brochure
             Human Research Training certifications           4.22 Internal IRB recognition form
             (within past 3 years)
             4.21A Conflict of Interest if needed

     Drug                                                   Device
             4.13C IRC Form                                       4.13B IRC Form
             Investigators Brochure                               Device identification, description, and
             IND number                                           risk analysis.
             Form 1572                                            IDE number, Contention of NSR or
                                                                  For IDE: Report of Prior Investigations.

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