APPLICATION CHECKLIST Initial Application Expedited and Full Board Form 4.10 – 4/10/09 Electronic Submissions: Send all materials by e-mail to firstname.lastname@example.org. Identify each attachment with a common name (e.g., company or study number). Send consent form in Word. 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 STUDY MATERIALS 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 INVESTIGATOR MATERIALS 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 INVESTIGATIONAL TEST ARTICLE INFORMATION 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 Exemption For IDE: Report of Prior Investigations.
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