The following are manuals, policies, and forms for the QACT, DSMP, DSMB, DSMC, auditing, registration, and 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