Protocol Development
- Protocol Template
- Informed Consent Template
- Ancillary Protocol Template
- Study Initiation Meeting (SIM) Template
Protocol Submission
Program Guidelines
- Publication Guidelines
- Program Guidelines
- Minimum Data Set (MDS) Guidelines
- Guidelines for Change in Principal Investigator
- Guidelines for Change in Principal Investigator
Regulatory Documents
- Delegation of Tasks Log and Registration and Credential Repository (RCR) Guidance
- NCI Registration and Credential Repository (RCR)
- RCR Registration Tool
- Delegation of Tasks Log (DTL)
- Delegation of Tasks Log (DTL) Study Tasks List
- Master Documentation File (MDF) Guidance
- Study Site Binder (SSB) Guidance
Monitoring and Auditing Documents
- Audit Plan for Lead Academic Organizations (LAOs)
- Audit Plan for Affiliate Organizations (AOs)
- Study-Specific Monitoring Plan Guidance Document
- Study Initiation Meeting (SIM) Template
- Monitoring Visit Report Template
- Monitoring Visit Action Item Site Response Template
AQuIP Accrual Reporting
Please see the Accrual Report Training Webinars (English, Spanish, and Portuguese) on the right-hand side of this page.
- The AQuIP Accrual Report Templates, in:
- The AQuIP Accrual Report Query Lists, in:
- The Recruitment Journal Study Events template (English only)
- Lead Academic Organization & Affiliate Organization Responsibilities (English only)