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DCP Consortia for Early Phase Trials

Guide to DCP Study Close-Out: Milestones and Tasks

This guide assists Consortium Lead Organization (CLO) planning for DCP study close-out. Study close-out tasks are organized under milestones, which help mark progress toward completion of the close-out process. Once tasks associated with a milestone are underway, planning for the next milestone may begin.

Click on a milestone to view the associated close-out tasks.

Milestone 1: Study Accrual Nearing Completion

Milestone 2: Last Participant Completes Study

Milestone 3: Research Lab Analyses

Milestone 4: Database Lock

Milestone 5: Statistical Analysis, Study Completion, and Unblinding

Milestone 6: Final Manuscript Submission