Guide to DCP Study Close-Out
Milestone 2: Last Participant Completes Study (ALL Tasks)
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- 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:
a. Paper CRFs and data entry are completed for all study visits.
b. 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.
Forms and Resources
Study Status Update Form (doc - 33kb)
A required form that lists study statuses from "Active" through "Completed".
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 firstname.lastname@example.org or (888) 662-8354.
Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)
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