HELPFUL TOOLS

 

Study Checklists

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)

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

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

CRF Completion

Coordination Center

Drug/Device Accountability

IRB Submission & Continuing Review
IND Submission

Screening and Enrollment

SOP Writing

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