Patient Support Materials Patient Support MaterialsYesClinical OperationsStudy Start Up Regulatory Approval Maintenance
Investigator Brochure Updates Investigator Brochure UpdatesNoClinical OperationsStudy Conduct Regulatory Approval Maintenance
Protocol Amendments Protocol AmendmentsNoClinical OperationsStudy Conduct Regulatory Approval Maintenance
Local Ethics Committee Approvals Local Ethics Committee ApprovalsNoClinical OperationsStudy Conduct Regulatory Compliance
Regulatory Authority Inspections Regulatory Authority InspectionsNoRegulatoryStudy Conduct Regulatory Compliance
Delegation of Authority Log Delegation of Authority LogNoClinical OperationsStudy Conduct Regulatory Compliance
Adverse Event Reporting Forms Adverse Event Reporting FormsNoSafetyStudy Conduct Safety Monitoring Regulatory Compliance
Site Closeout Visit Reports Site Closeout Visit ReportsNoClinical OperationsStudy Conduct Site Closeout
Site Closeout Documentation Site Closeout DocumentationNoClinical OperationsStudy Conduct Site Closeout
Study Progress Reports Study Progress ReportsNoClinical OperationsStudy Management Regulatory Compliance
Study Committee Charters Study Committee ChartersNoClinical OperationsStudy Management Regulatory Compliance
Clinical Study Report (CSR) Clinical Study Report (CSR)NoClinical OperationsStudy Results Regulatory SubmissionDisclosure
Investigational Product Label Investigational Product LabelYesClinical OperationsStudy Start Up Clinical Trial Regulatory Approval Investigational Product & Supplies
Patient Recruitment Material Patient Recruitment MaterialYesClinical OperationsStudy Start Up Clinical Trial Regulatory Approval Maintenance
Regulatory Submission Letter Regulatory Submission LetterYesClinical OperationsStudy Start Up Maintenance
Preclinical Study Reports Preclinical Study ReportsYesClinical OperationsStudy Start Up Regulatory Approval
Letter of Authorization Letter of AuthorizationYesClinical OperationsStudy Start Up Regulatory Approval
Informed Consent Forms (ICFs) Informed Consent Forms (ICFs)YesClinical OperationsStudy Start Up Regulatory Approval Maintenance