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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 5: Statistical Analysis, Study Completion, and Unblinding (ALL Tasks)

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Tasks


  • 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, following CLO standard institutional procedures, study agent assignments to PO sites so study participants may be notified. If the CLO was an enrolling site, follow institutional procedures for notifying participants.

Timing Reminders


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.


Forms and Resources


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.



Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)

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