• Confirm the Study Statistician's receipt of the final SAS dataset from the DCP Monitoring Contractor and the timeframe for completion of data analysis. Keep in mind the DCP-specified deadline for final study manuscript submission.
• Submit the Study Status Update Form to DCP-Protocol Information Office to communicate the "completed" study status.



• Tasks For Blinded Studies Only:

  (after statistical analysis is complete)
  
  Obtain approval for unblinding from the DCP Medical Monitor or their designee.
• Notify the DCP Monitoring Contractor to initiate the unblinded data transfer process.
• Communicate study agent assignments to PO sites using CLO standard institutional procedures to notify study participants. If the CLO was an enrolling site, follow institutional procedures for notifying participants.

• The final manuscript is due to the DCP Medical Monitor, DCP COR, and the DCP-Protocol Information Office within 60 calendar days of study completion, or as specified in the CLO's contract.

• Study Status Update Form (doc - 33kb)
  A required form that lists study statuses from "Active" through "Completed."
• Unblinded Data Procedure: Procedure for RDC Integration of Unblinded Data for DCP Chemoprevention Consortia Studies
  Available to approved users via the CDT website. To access, log in to the password-protected CDT website and click on the "User Tools and Documentation" link.
• Checklist for Study Close-Out (doc - 67kb)
  A planning tool for recording the projected and actual dates for close-out task completion.

Questions? Contact the DCP Help Desk at dcphelpdesk@westat.com or (888) 662-8354.