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, & Other Regulatory Binder Necessities

• NCI Cooperative Group Guidelines, October 2006 [External Link]
• NCI Investigator's Handbook and Guidelines for Multicenter Collaborations
  [External Links]
• ACRIN Principal Investigator Manual [PDF]
• ICH Guidance for Industry: E6 Good Clinical Practice [External Link]
• NCI Monitoring Guidelines, 2006 [External Link]
• ACRIN Audit Manual [PDF]
• ACRIN Statement of Investigator [PDF]
• Form FDA 1572 [PDF]
• NCI FAQs - Statement of Investigator (Form FDA 1572) [External Link]
  (includes instructions on appropriate completion of sections of the
  Form FDA 1572)
• Conflict of Interest Policy Statement & Disclosure Form [PDFs]
• ACRIN HIPAA Policy [Site Link]
• Study Staff Signature and Responsibility Log [DOC]

Adverse Event-Related Materials

• ACRIN Adverse Event Reporting Manual [PDF]
• ACRIN Adverse Event (AE) Log [PDF] (optional source document)
• Submit an AdEERS Report [External Link]
  •  CTCAE v 3.0 [PDF]
  •  CTCAE v 4.0 [PDF]
  •  CTCAE v 4.0 (Code Look Up) [XLS]
• Electronic AdEERS Training [DOCs and Zip File]
  •   Instructions for the Electronic AdEERS Webinar
  •   Electronic AdEERS Webinar
  •   Document Your Training With ACRIN
• Practice Submitting an AdEERS Report [External Link]

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]
• Informed Consent Template & Checklist [DOCs]

Additional Links to Regulatory Resources

• Cancer Therapy Evaluation Program (CTEP) [External Link]
• Electronic Code of Federal Regulations [External Link]
• FDA Information Sheets [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)