Startup
[prettyfilelink size=”256 kB” src=”/wp-content/uploads/ITHSResearchResources-GCPChecklist1.doc” type=”doc”]GCP Checklist[/prettyfilelink][prettyfilelink size=”51 KB” src=”https://www.iths.org/wp-content/uploads/StudyStartUpChecklist.docx” type=”doc”]Study Start-Up Checklist[/prettyfilelink][prettyfilelink size=”177 kB” src=”/wp-content/uploads/ITHSDSMBChartertemplate.doc” type=”doc”]DSMB Charter Template[/prettyfilelink][prettyfilelink size=”220 KB” src=”https://www.iths.org/wp-content/uploads/All-Startup-Files-1.zip” type=”zip”]All Startup Files[/prettyfilelink]
Implementation
[prettyfilelink size=”42 KB” src=”https://www.iths.org/wp-content/uploads/StudyImplementationChecklist.docx” type=”doc”]Study Implementation Checklist[/prettyfilelink][prettyfilelink size=”58 kB” src=”/wp-content/uploads/DMCReportTemplate.doc” type=”doc”]DSMB Report Template[/prettyfilelink][prettyfilelink size=”94 KB” src=”https://www.iths.org/wp-content/uploads/SelfQA_RegulatoryDocumentsChecklist.doc” type=”doc”]Self-QA-Regulatory Documents Checklist[/prettyfilelink][prettyfilelink size=”95 KB” src=”https://www.iths.org/wp-content/uploads/SelfQA_ParticipantRecordsChecklist.doc” type=”doc”]Self-QA-Participant Records Checklist[/prettyfilelink][prettyfilelink size=”121 KB” src=”https://www.iths.org/wp-content/uploads/All-Implementation-Files.zip” type=”zip”]All Implementation Files[/prettyfilelink]
Closeout
[prettyfilelink size=”39 KB” src=”https://www.iths.org/wp-content/uploads/StudyCloseoutChecklist.docx” type=”doc”]Study Closeout Checklist[/prettyfilelink]
Regulatory Binder Forms
[prettyfilelink size=”155 kB” src=”/wp-content/uploads/ITHSResearchResources-RegBinderContents.doc” type=”doc”]Regulatory Binder Contents Checklist[/prettyfilelink][prettyfilelink size=”208 kB” src=”/wp-content/uploads/ITHSResearchResources-StudyContactInformation.docm” type=”doc”]Study Contact Information[/prettyfilelink][prettyfilelink size=”149 kB” src=”/wp-content/uploads/ITHSResearchResources-SignatureListDelegationResponsibility.doc” type=”doc”]Signature List and Delegation of Responsibilities Log[/prettyfilelink][prettyfilelink size=”139 kB” src=”/wp-content/uploads/ITHSResearchResources-StudyPersonnelLicensureVerification.doc” type=”doc”]Study Personnel Licensure Verification[/prettyfilelink][prettyfilelink size=”136 kB” src=”/wp-content/uploads/ITHSResearchResources-StudyTeamTrainingLog.doc” type=”doc”]Study Team Training Log[/prettyfilelink][prettyfilelink size=”120 kB” src=”/wp-content/uploads/ITHSResearchResources-MeetingMinutes.doc” type=”doc”]Meeting Minutes[/prettyfilelink][prettyfilelink size=”136 kB” src=”/wp-content/uploads/ITHSResearchResources-SubjectScreeningEnrollmentWithdrawalCompletionLog.doc” type=”doc”]Subject Screening Enrollment Withdrawal Completion Log[/prettyfilelink][prettyfilelink size=”137 kB” src=”/wp-content/uploads/ITHSResearchResources-SubjectIDLog.doc” type=”doc”]Subject ID Log[/prettyfilelink][prettyfilelink size=”136 kB” src=”/wp-content/uploads/ITHSResearchResources-INDSafetyReportLog.doc” type=”doc”]IND Safety Report Log[/prettyfilelink][prettyfilelink size=”133 kB” src=”/wp-content/uploads/ITHSResearchResources-PhoneCallLog.doc” type=”doc”]Phone Call Log[/prettyfilelink][prettyfilelink size=”136 kB” src=”/wp-content/uploads/ITHSResearchResources-IRBSubmissionandApprovalTrackingLog.doc” type=”doc”]IRB Submission and Approval Tracking Log[/prettyfilelink][prettyfilelink size=”143 kB” src=”/wp-content/uploads/ITHSResearchResources-ConsentFormVersionLog.doc” type=”doc”]ITHSResearchResources-ConsentFormVersionLog[/prettyfilelink][prettyfilelink size=”141 kB” src=”/wp-content/uploads/ITHSResearchResources-StudyProductDispensationandAccountabilityLog.doc” type=”doc”]Study Product Dispensation and Accountability Log[/prettyfilelink][prettyfilelink size=”139 kB” src=”/wp-content/uploads/ITHSResearchResources-MasterAdverseEventLog.doc” type=”doc”]Master Adverse Event Log[/prettyfilelink][prettyfilelink size=”141 kB” src=”/wp-content/uploads/ITHSResearchResources-MasterSeriousAdverseEventLog.doc” type=”doc”]Master Serious Adverse Event Log[/prettyfilelink][prettyfilelink size=”132 kB” src=”/wp-content/uploads/ITHSResearchResources-ProtocolDeviationLog.doc” type=”doc”]Protocol Deviation Log[/prettyfilelink][prettyfilelink size=”147 kB” src=”/wp-content/uploads/ITHSResearchResources-StudyMonitoringandSiteVisitLog.doc” type=”doc”]Study Monitoring and Site Visit Log[/prettyfilelink][prettyfilelink size=”1 MB” src=”/wp-content/uploads/All-Regulatory-Binder-Forms.zip” type=”zip”]All Regulatory Binder Forms[/prettyfilelink]
