Forms, Policies, and Manuals

The following are manuals, policies, and forms for the QACT, DSMP, DSMB, DSMC, auditing, registration, and multi-center trials.

QACT Manual

Multi-Center Trials

Data and Safety Monitoring
Data and Safety Monitoring Plan (DSMP) - Summary
Data and Safety Monitoring Plan (DSMP)

Data and Safety Monitoring Board (DSMB) for Phase III Protocols
DSMB for Phase III Protocols Form
DSMB for Phase III Protocols (0 accrual) Form

Data and Safety Monitoring Committee (DSMC) for Phase I & II High Risk Protocols
DSMC for Phase I & II High Risk Protocols Form

Auditing
Clinical Trials Audit Manual
Clinical Trial Standards Applied During Audit Proceedings

Protocol Registration
Eligibility Checklist Development and Implementation
Protocol Registration Form (for protocols without eligibility checklists)
QACT Pediatric Non-research Registration Form
In-house Phase I Clinical Trials Dose Escalation Form
DF/HCC Phase II Clinical Trials Early Stopping Rule Form
Treatment Ended/Off Study Form

DF/HCC Subject Registration Policy

Other
Protocol Data Request Form
CTC Version 2 QACT Toxicity Codes
CTC Version 3 QACT Toxicity Codes

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  • Office for Human Research Studies (OHRS)
  • Quality Assurance Office for Clinical Trials (QACT)
    • Forms, Policies, and Manuals
    • Multi-Center Trials
    • Contacts
    • Clinical Research List-serv
    • FAQ
  • Clinical Investigations Leadership Committee (CLC)
  • Clinical Trials Education Office (CTEO)
  • Clinical Research Unit (CRU)
  • Protocol Review and Monitoring System (PRMS)
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