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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out
Milestone 1: Study Accrual Nearing Completion

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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  • Estimate when each enrolling site will complete accrual and each site’s last participant will go off study.
  • Ensure the CLO Monitors are scheduling each PO close-out visit to occur close to when the PO’s last participant completes the study.
  • Schedule a call with the DCP Monitoring Contractor to discuss preparations for database lock.
  • Discuss an expected date for submission of the draft manuscript with the Protocol PI and DCP Medical Monitor.

    The draft manuscript is due to the DCP-PIO and DCP Medical Monitor within 120 calendar days when:

    a.   All participants have met the primary study endpoint, and
    b.   At least 80% of participants are off-study.

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

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