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] (NEW July 2010)

§         ICH Guidance for Industry: E6 Good Clinical Practice [External Link]

§         NCI Monitoring Guidelines, 2006 [External Link]

§         ACRIN Audit Manual [PDF] (NEW June 2010)

§         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 Material

§         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] (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 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)