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.
- 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 firstname.lastname@example.org or (888) 662-8354.
Key to common acronyms: DCP Consortia Acronym List, (doc 61kb)
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