ABSTRACT
Signed FDA Form 1572 I IRB approval of Protocol and ICF CV for Principal Investigator IRE3 approval of advertisements 0 CVs for Subinvestigators List of IRE3 members or assurance #
Indemnification
Financial Disclosure for Study Coordinator
Laboratory certification
Signed Protocol Signature Page I Laboratory normal values Draft Informed Consent 0 l Other:
3 1. Record retention
Signature of person who conducted the visit Date
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