HELPFUL TOOLS
Study Checklists
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| Subject Eligibility checklist | |
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Study Management Tools
Study Start-up:
Annotated CRFs: |
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CLIA Certification / Lab Normal Reference Ranges (MGH & BWH) (new) |
| Monitoring Plan Template | |
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Study Maintenance:
| Coordination Center Regulatory Documentation Tracking | |
| Documentation of Informed Consent | |
| Note-to-File | |
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Minor Deviations/Violations Tracking Log (New) - To faciliate reporting at Continuing Review |
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Staff Signature / Delegation of Responsibility (v2) |
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Subject Enrollment (v2) |
| Temperature Log |
QI Guidance Documents
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| CRF Completion | |
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| IND Submission | |
| Subjects Lost to Follow-up | |
*To
download files to a PC: click your right mouse button and select "Save Target As."
Human Research Quality Improvement Program 2008