QI TOOLS

I. Study Checklists

Study Start-up checklist for Minimal Risk Research
Subject Eligibility checklist
Visit Timeline checklist
Data & Safety Monitoring Plan checklist
Informed Consent Compliance checklist
Self-Assessment checklist  (Updated)
    o Self-Assessment Checklist Completion Instructions (NEW)
FDA Sponsor & Investigator Responsibility checklist (Updated)


II. Study Logs

Adverse Event Tracking (Updated)
Coordination Center Regulatory Documentation Tracking
Device Accountability
Drug Accountability
Monitoring
Pre-Screening Log
Protocol Amendment/Version Tracking Log
Minor Deviations Tracking Log (Updated)
           to facilitate reporting at Continuing Review
Staff Signature / Delegation of Responsibility (Updated)
bullet Study Staff Training Log (NEW)
Subject Contact Log
Subject Enrollment
Temperature Log
Tissue Log


III. Annotated CRFs

   o Inclusion Criteria
   o Exclusion Criteria
   o Demographics
   o Medical History
   o Physical Exam
   o Con-meds
   o Labs
   o Adverse Events
   o Off Study Form


IV. Miscellaneous Tools

Monitoring Plan Template
Note-to-File
Subject Information Sheet
Documentation of Informed Consent
 Meeting Minute Template (NEW)


V. QI Guidance Documents

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

 


Please note that these tools are one component of the quality improvement process and are used to ensure compliance with federal regulations and Partners HealthCare Policies. They should be used as a starting point to meet your specific needs for developing tools at your own institution.


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

 

 

 

 

 

                                                                                Human Research Quality Improvement Program 2010