HELPFUL TOOLS

	Data & Safety Monitoring Plan checklist
	FDA Sponsor & Investigator Responsibility checklist
	Informed Consent Compliance checklist
	Self-Assessment checklist
	Subject Eligibility checklist
	Visit Timeline checklist

Study Management Tools

Study Start-up:

	Annotated CRFs: (new) Inclusion Criteria Exclusion Criteria Demographics Medical History Physical Exam Con-meds Labs Adverse Events Off Study Form
	CLIA Certification / Lab Normal Reference Ranges (MGH & BWH) (new)
	Monitoring Plan Template (new)
	Pre-Screening Log
	Subject Information Sheet

Study Maintenance:

	Adverse Event Tracking
	Coordination Center Regulatory Documentation Tracking
	Device Accountability
	Documentation of Informed Consent (new)
	Drug Accountability
	Monitoring
	Note-to-File (new)
	Protocol Amendment/Version Tracking Log Direction for Completing Amendment Log
	Protocol Deviation/Exception Tracking
	Protocol Violation Tracking
	Staff Signature / Delegation of Responsibility
	Staff Signature / Delegation of Responsibility (v2)
	Subject Contact Log (new)
	Subject Enrollment
	Subject Enrollment (v2)

Temperature Log

QI Guidance Documents (new)

	Audit Preparation - FDA Inspection FDA Audit Prep checklist
	CRF Completion
	Coordination Center
	Drug/Device Accountability
	IRB Submission & Continuing Review
	IND Submission
	Screening and Enrollment
	SOP Writing Sample Informed Consent SOP Sample Product Accountability SOP SOP Cover Page
	Study Close-Out
	Subjects Lost to Follow-up
	21 CFR Part 11 Compliance

*To download files to a PC: click your right mouse button and select "Save Target As."

Human Research Quality Improvement Program 2008