Here is a listing of documents and forms that will be useful for your protocol development and submission.
MBRCC Clinical Trials Operations Manual "The Blue Book"
DSMP - Data Safety and Monitoring Plan
Protocol Design and Development Checklist
Protocol Template
Informed Consent Template - More than minimal risk
Informed Consent Template - Only minimal risk
PRMC Submission Form - Treatment
PRMC Submission Form - Non-Treatment
PRMC Members Roster
DSTC Members Roster
Clinical Trials Disease Team Roster