PKUfQ6Regulatory File Template GCP/1. Initial Approval DATE/PK|.HHRegulatory File Template GCP/1. Initial Approval DATE/Approved Consents/PKIc4HHRegulatory File Template GCP/1. Initial Approval DATE/Approved Protocol/PKNLKRegulatory File Template GCP/1. Initial Approval DATE/Approved Recruitment/PK|.HJRegulatory File Template GCP/1. Initial Approval DATE/IRB Approval Letter/PK|.HHRegulatory File Template GCP/1. Initial Approval DATE/Working Documents/PKUfQ3Regulatory File Template GCP/2. Modification# DATE/PK|.HERegulatory File Template GCP/2. Modification# DATE/Approved Consents/PKIc4HERegulatory File Template GCP/2. Modification# DATE/Approved Protocol/PKNLHRegulatory File Template GCP/2. Modification# DATE/Approved Recruitment/PK|.HGRegulatory File Template GCP/2. Modification# DATE/IRB Approval Letter/PK|.HERegulatory File Template GCP/2. Modification# DATE/Working Documents/PKUfQ8Regulatory File Template GCP/3. Continuing Review# DATE/PK|.HJRegulatory File Template GCP/3. Continuing Review# DATE/Approved Consents/PKNLMRegulatory File Template GCP/3. Continuing Review# DATE/Approved Recruitment/PKUfQLRegulatory File Template GCP/3. Continuing Review# DATE/IRB Approval Letter/PK|.HJRegulatory File Template GCP/3. Continuing Review# DATE/Working Documents/PKCmPHRegulatory File Template GCP/Ancillary Committee Approval-as applicable/PKUfQ6Regulatory File Template GCP/Continuing Review#X DATE/PK|.HHRegulatory File Template GCP/Continuing Review#X DATE/Approved Consents/PKNLKRegulatory File Template GCP/Continuing Review#X DATE/Approved Recruitment/PK|.HJRegulatory File Template GCP/Continuing Review#X DATE/IRB Approval Letter/PK|.HHRegulatory File Template GCP/Continuing Review#X DATE/Working Documents/PKKfQ>Regulatory File Template GCP/Data Security Form-as applicable/PK~pQ'Regulatory File Template GCP/GCP Items/PKY;I,Regulatory File Template GCP/GCP Items/1572/PKY;I+Regulatory File Template GCP/GCP Items/CVs/PK1Z;I>Regulatory File Template GCP/GCP Items/Data&Safety Monitoring/PK|UfQ7Regulatory File Template GCP/GCP Items/FinanDisclosure/PKUfQ>Regulatory File Template GCP/GCP Items/Investigational Device/PKLQM?Regulatory File Template GCP/GCP Items/Investigational Product/PKZ;INRegulatory File Template GCP/GCP Items/Investigational Product/Dispensing Log/PKY;IURegulatory File Template GCP/GCP Items/Investigational Product/Investigator Brochure/PK&Z;IQRegulatory File Template GCP/GCP Items/Investigational Product/IP Accountability/PKZ;IERegulatory File Template GCP/GCP Items/Investigational Product/Label/PK"Z;IORegulatory File Template GCP/GCP Items/Investigational Product/Temperature Log/PKLQM2Regulatory File Template GCP/GCP Items/Laboratory/PKY;IERegulatory File Template GCP/GCP Items/Laboratory/Lab Certs Licenses/PKY;IBRegulatory File Template GCP/GCP Items/Laboratory/Lab Director CV/PKY;I=Regulatory File Template GCP/GCP Items/Laboratory/Lab Ranges/PK~pQ0Regulatory File Template GCP/GCP Items/Licenses/PKLQM,Regulatory File Template GCP/GCP Items/Logs/PKY;ICRegulatory File Template GCP/GCP Items/Logs/Copy of Delegation Log/PKY;IBRegulatory File Template GCP/GCP Items/Logs/Copy of Signature Log/PKGP=I;Regulatory File Template GCP/GCP Items/Logs/Enrollment Log/PKZ;IERegulatory File Template GCP/GCP Items/Logs/Identification Code List/PK Z;I>Regulatory File Template GCP/GCP Items/Logs/Randomization Log/PKLQM-Regulatory File Template GCP/GCP Items/Other/PKY;IERegulatory File Template GCP/GCP Items/Other/Cert of Confidentiality/PKgZ;I;Regulatory File Template GCP/GCP Items/Other/COI Mgt Plans/PK,Z;I9Regulatory File Template GCP/GCP Items/Other/CRA Letters/PKY;IARegulatory File Template GCP/GCP Items/Other/IND-IDE Information/PKpZ;I;Regulatory File Template GCP/GCP Items/Other/Training Info/PK2LfQ>Regulatory File Template GCP/Letters of Support-as applicable/PKUfQ*Regulatory File Template GCP/MOD-CR# DATE/PK|.H<Regulatory File Template GCP/MOD-CR# DATE/Approved Consents/PKUUfQ<Regulatory File Template GCP/MOD-CR# DATE/Approved Protocol/PKNL?Regulatory File Template GCP/MOD-CR# DATE/Approved Recruitment/PK|.H>Regulatory File Template GCP/MOD-CR# DATE/IRB Approval Letter/PK|.H<Regulatory File Template GCP/MOD-CR# DATE/Working Documents/PKUfQ1Regulatory File Template GCP/Modification#X DATE/PK|.HCRegulatory File Template GCP/Modification#X DATE/Approved Consents/PKIc4HCRegulatory File Template GCP/Modification#X DATE/Approved Protocol/PKNLFRegulatory File Template GCP/Modification#X DATE/Approved Recruitment/PK|.HERegulatory File Template GCP/Modification#X DATE/IRB Approval Letter/PK|.HCRegulatory File Template GCP/Modification#X DATE/Working Documents/PKVfQ5Regulatory File Template GCP/New Information Reports/PKP`6HLRegulatory File Template GCP/New Information Reports/Reportable Event# DATE/PKUfQ6Regulatory File Template GCP/1. Initial Approval DATE/PK|.HHTRegulatory File Template GCP/1. Initial Approval DATE/Approved Consents/PKIc4HHRegulatory File Template GCP/1. Initial Approval DATE/Approved Protocol/PKNLK Regulatory File Template GCP/1. Initial Approval DATE/Approved Recruitment/PK|.HJRegulatory File Template GCP/1. Initial Approval DATE/IRB Approval Letter/PK|.HHRegulatory File Template GCP/1. Initial Approval DATE/Working Documents/PKUfQ3WRegulatory File Template GCP/2. Modification# DATE/PK|.HERegulatory File Template GCP/2. Modification# DATE/Approved Consents/PKIc4HE Regulatory File Template GCP/2. Modification# DATE/Approved Protocol/PKNLHnRegulatory File Template GCP/2. Modification# DATE/Approved Recruitment/PK|.HGRegulatory File Template GCP/2. Modification# DATE/IRB Approval Letter/PK|.HE9Regulatory File Template GCP/2. Modification# DATE/Working Documents/PKUfQ8Regulatory File Template GCP/3. Continuing Review# DATE/PK|.HJRegulatory File Template GCP/3. Continuing Review# DATE/Approved Consents/PKNLMZRegulatory File Template GCP/3. Continuing Review# DATE/Approved Recruitment/PKUfQLRegulatory File Template GCP/3. Continuing Review# DATE/IRB Approval Letter/PK|.HJ/Regulatory File Template GCP/3. Continuing Review# DATE/Working Documents/PKCmPHRegulatory File Template GCP/Ancillary Committee Approval-as applicable/PKUfQ6Regulatory File Template GCP/Continuing Review#X DATE/PK|.HHQRegulatory File Template GCP/Continuing Review#X DATE/Approved Consents/PKNLKRegulatory File Template GCP/Continuing Review#X DATE/Approved Recruitment/PK|.HJ Regulatory File Template GCP/Continuing Review#X DATE/IRB Approval Letter/PK|.HHRegulatory File Template GCP/Continuing Review#X DATE/Working Documents/PKKfQ>Regulatory File Template GCP/Data Security Form-as applicable/PK~pQ'J Regulatory File Template GCP/GCP Items/PKY;I, Regulatory File Template GCP/GCP Items/1572/PKY;I+ Regulatory File Template GCP/GCP Items/CVs/PK1Z;I>" Regulatory File Template GCP/GCP Items/Data&Safety Monitoring/PK|UfQ7~ Regulatory File Template GCP/GCP Items/FinanDisclosure/PKUfQ> Regulatory File Template GCP/GCP Items/Investigational Device/PKLQM?/ Regulatory File Template GCP/GCP Items/Investigational Product/PKZ;IN Regulatory File Template GCP/GCP Items/Investigational Product/Dispensing Log/PKY;IU Regulatory File Template GCP/GCP Items/Investigational Product/Investigator Brochure/PK&Z;IQk Regulatory File Template GCP/GCP Items/Investigational Product/IP Accountability/PKZ;IE Regulatory File Template GCP/GCP Items/Investigational Product/Label/PK"Z;IO= Regulatory File Template GCP/GCP Items/Investigational Product/Temperature Log/PKLQM2 Regulatory File Template GCP/GCP Items/Laboratory/PKY;IE Regulatory File Template GCP/GCP Items/Laboratory/Lab Certs Licenses/PKY;IB]Regulatory File Template GCP/GCP Items/Laboratory/Lab Director CV/PKY;I=Regulatory File Template GCP/GCP Items/Laboratory/Lab Ranges/PK~pQ0Regulatory File Template GCP/GCP Items/Licenses/PKLQM,fRegulatory File Template GCP/GCP Items/Logs/PKY;ICRegulatory File Template GCP/GCP Items/Logs/Copy of Delegation Log/PKY;IBRegulatory File Template GCP/GCP Items/Logs/Copy of Signature Log/PKGP=I;qRegulatory File Template GCP/GCP Items/Logs/Enrollment Log/PKZ;IERegulatory File Template GCP/GCP Items/Logs/Identification Code List/PK Z;I>-Regulatory File Template GCP/GCP Items/Logs/Randomization Log/PKLQM-Regulatory File Template GCP/GCP Items/Other/PKY;IERegulatory File Template GCP/GCP Items/Other/Cert of Confidentiality/PKgZ;I;7Regulatory File Template GCP/GCP Items/Other/COI Mgt Plans/PK,Z;I9Regulatory File Template GCP/GCP Items/Other/CRA Letters/PKY;IARegulatory File Template GCP/GCP Items/Other/IND-IDE Information/PKpZ;I;FRegulatory File Template GCP/GCP Items/Other/Training Info/PK2LfQ>Regulatory File Template GCP/Letters of Support-as applicable/PKUfQ*Regulatory File Template GCP/MOD-CR# DATE/PK|.H<CRegulatory File Template GCP/MOD-CR# DATE/Approved Consents/PKUUfQ<Regulatory File Template GCP/MOD-CR# DATE/Approved Protocol/PKNL?Regulatory File Template GCP/MOD-CR# DATE/Approved Recruitment/PK|.H>TRegulatory File Template GCP/MOD-CR# DATE/IRB Approval Letter/PK|.H<Regulatory File Template GCP/MOD-CR# DATE/Working Documents/PKUfQ1 Regulatory File Template GCP/Modification#X DATE/PK|.HCYRegulatory File Template GCP/Modification#X DATE/Approved Consents/PKIc4HCRegulatory File Template GCP/Modification#X DATE/Approved Protocol/PKNLFRegulatory File Template GCP/Modification#X DATE/Approved Recruitment/PK|.HERegulatory File Template GCP/Modification#X DATE/IRB Approval Letter/PK|.HCRegulatory File Template GCP/Modification#X DATE/Working Documents/PKVfQ5CRegulatory File Template GCP/New Information Reports/PKP`6HLRegulatory File Template GCP/New Information Reports/Reportable Event# DATE/PKDD@