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)