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DCP Consortia for Early Phase Trials

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

Close-out Tasks appearing under each milestone are generally initiated in the same timeframe. Click on the Timing Reminders and Forms & Resources tabs for more information.

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  • 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.



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

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