Submitted Documents for Initial Review

	Indemnification Agreement for IRB
	IRB Fee Payment
	Research Study Summary (8 copies)
	Complete Study Protocol (8 copies)
	Complete Blank Case Report form (2 copies)
	Investigator’s Brochure (2 copies)
	Site Description Including Patient Population, Facility Capabilities In Medical Emergencies and Community Attitude Toward Clinical Research (1 each year for each site)
	Copy of Completed Form FDA 1572 (with IND number)
	CVs of Prinicpal and Sub-investigators (1 copy each)
	Professional Licenses of Principal and Sub-investigators (1 copy)
	Proposed Informed Consent Statement (8 copies)
	Proposed Advertisement/Recruitment Material (8 copies)
	Provide a statement indicating office or research facility's policy and methodology for maintaining confidentiality of patient identity and patient data, both on case report forms and patient medical records.
	Provide a completed form FDA 3454 or 3455 which concerns potential conflict of interest. Provide a list of individuals having anything to do with the study and whether or not any of them have any holdings in the study sponsor's company, its parent company or subsidiaries.
	State and Local Laws Affecting Clinical Research
	Patient Bill of Rights (if applicable)
	Proposed HIPAA authorization form or request for exemption, with regulatory justification.