Forms, Policies, and Manuals

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

Multi-Center Trials

Data and Safety Monitoring
Data and Safety Monitoring Plan (DSMP) - Summary
Data and Safety Monitoring Plan (DSMP) - Updated 1/10/13

Data and Safety Monitoring Board (DSMB) for Phase III Protocols -Updated 1/8/13
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 -Updated 2/22/12

DSMC for Phase I & II High Risk Protocols Form - Updated 2/22/12

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)
In-house Phase I Clinical Trials Dose Escalation Form
DF/HCC Phase II Clinical Trials Early Stopping Rule Form
Treatment Ended/Off Study Form (updated 7/27/10)
Subject Transfer Form
DF/HCC Subject Registration Policy

Other
Protocol Data Request Form - Updated 4/27/12

CTC Version 2 QACT Toxicity Codes

CTC Version 3 QACT Toxicity Codes

 CTC Version 4 QACT Toxicity Codes

 Guidance on DF/HCC Website Clinical Trial List