PROTOCOL DEVELOPMENT & REGULATORY RESOURCES

The following links provide a comprehensive index of materials related to clinical trial regulatory compliance, adverse event reporting, and concept/protocol development.

Regulatory Materials: Manuals & Policies

§         NCI Cooperative Group Guidelines, August 1996 
[External Link] (new guidelines under development)

§         NCI Investigator's Handbook [External Link]

§         ACRIN Principal Investigator Manual [PDF] (update coming soon)

§         NCI Monitoring Guidelines, 2006 [External Link]

§         ACRIN Audit Manual [PDF] (under revision)

§         ACRIN Statement of Investigator [PDF]

§         FDA 1572 Form [PDF]

§         Conflict of Interest Policy Statement & Disclosure Form [PDFs]

§         ACRIN HIPAA Policy [Site Link]

 

Adverse Event­–Related Material

§         ACRIN Adverse Event Reporting Manual [PDF] (NEWLY REVISED!)

§         ACRIN General Adverse Event Information Sheet [PDF] (NEW!)

§         ACRIN Expedited Adverse Event Instructions [PDF] (NEW!) 

§         ACRIN Adverse Event (AE) Log [PDF] (optional source document)

§         AdEERS Form [PDF]

§         AdEERS Computer Base Training [External Link]

§         CTCAE v 3.0 [PDF]

 

Research Concept and Protocol Development Templates

§         ACRIN Concept Submission & Protocol Development [Site Link]

§         Preliminary Concept Development Template [DOC]

§         Protocol Concept Submission Template (for CTEP submission) 
[External Link]

§         Protocol Development Template [DOC] (under revision)

§         Informed Consent Template & Checklist [DOC] (under revision)

 

Additional Links to Regulatory Resources

§         Cancer Therapy Evaluation Program (CTEP) [External Link]

§         Electronic Code of Federal Regulations [External Link]

§         FDA Information Sheet [External Link]

§         Office of Human Research Protections Web Site [External Link] (FWA Number/IRB Organization Number)

§        Protecting Human Research Participants [External Link] (many institutions will have their own course addressing human research protections; this online course is offered by the National Institutes of Health)