Guide to DCP Study Close-Out
Milestone 1: Study Accrual Nearing Completion (ALL Tasks)
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Tasks
- 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.
Timing Reminders
The draft manuscript is due to the DCP-PIO and DCP Medical Monitor within 120 calendar days when:
- All participants have met the primary study endpoint, and
- At least 80% of participants are off-study.
Forms and Resources
DCP OC-RDC CLO Data Lock Checklist/Request (doc - 65kb)
A checklist for planning database lock. Once completed, it is submitted to request lock
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 1-888-662-8354.
Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)
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