Guide to DCP Study Close-Out
Milestone 2: Last Participant Completes Study
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.
- Submit the Study Status Update Form to DCP-PIO when the last participant at the last site goes off study.
- Determine the projected request date for database lock and final dataset delivery and notify the DCP Monitoring Contractor via the DCP Help Desk.Consult with the PO Site Coordinators and CLO data management staff to ensure that:
1. Paper CRFs and data entry are completed for all study visits.
2. QA reviews are completed per the approved Master DMP.
- Ensure the CLO Monitor(s) complete(s) a close-out visit and, if necessary, a final annual/interim monitoring visit at each PO site per the DCP SOPs.
- Data in the DCP OC-RDC database should be accurate, complete, clean, audited, and locked for analysis within three months of the last participant’s exit from the study.
Questions? Contact the DCP Help Desk at firstname.lastname@example.org or (888) 662-8354.
Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)
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