This document is intended for the use of the DCP Consortia staff conducting cancer chemoprevention studies under contract with the NCI/DCP. ______

CHECKLIST FOR SUBSEQUENT SUBMISSION OF REGULATORY DOCUMENTS

Institution Submitting Documents: /
Consortium Lead Organization
(CLO) /
Participating Organization
(PO)
Protocol Number and Title:
Date Submitted to CLO:
PO Institution Name:
Submitted By:
Date Received by CLO:
Received By:
A)Investigator Documentation / Yes / No / Comments
Investigator Documentation included in this submission?
Changes to Form FDA 1572?
  • List all changes to Form FDA 1572:
(List all in comments section)
Per changes to Form FDA 1572, documentation for the following also included:
  • Investigator(s) CV?
  • Human Subjects Protection Training?
  • Financial Disclosure Form?
  • Professional License (where applicable)?
/ N/A
B)Lab Certifications and Reference Information / Yes / No / Comments
Lab Certifications and Reference Information included in this submission?
Current Lab Certifications:
Updated CLIA and CAPLab Certifications for lab(s) listed on the Form FDA 1572?
C)Lab Normal Values / Yes / No / Comments
Updated list of institutional Lab Normal Values present for lab(s) listed on 1572?
D)IRB/IEC Documentation- Approval/Protocol Versions / Yes / No / Comments
IRB/IEC Documentation included in this submission?
IRB/IEC Approval of Protocol Amendment(s)?
  • List date of Protocol Amendment(s) (and version number, if applicable) and date of IRB/IEC approval:
(List all in comments section)
E)IRB/IEC Documentation - Informed Consent/Other Items / Yes / No / Comments
IRB/IEC Approval of Revised Informed Consent(s)?
  • List date (and version number, if applicable) of revised Informed Consent(s), and dates of IRB/IEC approval:
(List all in comments section)
F)IRB/IEC Approval of Other Item(s) / Yes / No / Comments
IRB/IEC approval of other item(s)?
  • List item (e.g., Recruitment or Educational material, Safety Report), date of item, and date of IRB/IEC approval:
(List all in comments section)
G)Other / Yes / No / Comments

DCP Version Date: August 20, 20101