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256 kBGCP Checklist51 KBStudy Start-Up Checklist177 kBDSMB Charter Template220 KBAll Startup Files
42 KBStudy Implementation Checklist58 kBDSMB Report Template94 KBSelf-QA-Regulatory Documents Checklist95 KBSelf-QA-Participant Records Checklist121 KBAll Implementation Files
155 kBRegulatory Binder Contents Checklist208 kBStudy Contact Information149 kBSignature List and Delegation of Responsibilities Log139 kBStudy Personnel Licensure Verification136 kBStudy Team Training Log120 kBMeeting Minutes136 kBSubject Screening Enrollment Withdrawal Completion Log137 kBSubject ID Log136 kBIND Safety Report Log133 kBPhone Call Log136 kBIRB Submission and Approval Tracking Log143 kBITHSResearchResources-ConsentFormVersionLog141 kBStudy Product Dispensation and Accountability Log139 kBMaster Adverse Event Log141 kBMaster Serious Adverse Event Log132 kBProtocol Deviation Log147 kBStudy Monitoring and Site Visit Log1 MBAll Regulatory Binder Forms