Clinical Data Readiness NavigatorOperational readiness for clinical data, analysis, and submission milestones.
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Illustrative scenario · synthetic data

A database lock in two weeks, and the tracker says 87 percent.

Follow one synthetic study through the CDRN Framework: the problem, the milestone, the readiness inputs, the dependencies that matter, the risks, and the plan with owners and completion evidence. Then change the facts and watch the readiness status respond.

Illustrative Scenario. ZEPHYR-101 is a fictional study. Every number on this page is invented to show how the method works. Nothing here is a real clinical trial outcome, benchmark or prediction.

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  1. 1

    Problem

    ZEPHYR-101 is a fictional Phase 2 study. Database lock is planned in 14 calendar days. Programming is largely complete, but three ADaM decisions are still open with Biostatistics, the final central laboratory transfer from an external vendor is late, and independent QC capacity is tight. The weekly tracker reports 87 percent of outputs complete.

  2. 2

    Selected milestone

    Milestone
    Database lock, followed by topline outputs
    Target date
    Day 0, which is 14 calendar days (9 working days) from today
    Planning role
    Statistical programming lead
    Deliverable
    12 ADaM datasets and 62 topline tables, listings and figures, ready to run on locked data
  3. 3

    Readiness inputs

    CDRN asks for the same seven inputs every time: role, milestone, target date, deliverable, dependencies, risk and evidence. Completion counts are recorded, but they do not decide the readiness status.

    Percent complete87%54 of 62 TLF programs and 11 of 12 ADaM datasets written and validated on current data
    Readiness statusNot readyDecided by open dependencies against their latest acceptable dates
  4. 4

    Identified dependencies

    Each dependency has an owner and a latest acceptable date: the last day it can be resolved and still leave time for the work that follows it (rule CDRN-R1). An item resolved two or more days before that date is clear, less than two days is watch, and after it is blocking (CDRN-R2).

    DependencyOwnerLatest acceptable dateCurrent positionStatus
  5. 5

    Change the facts

    Tick what the team manages to secure. The statuses above and the plan below update using the documented rules.

  6. 6

    Risks

    • 7

      Recommended actions, responsible roles and completion evidence

      Every open item gets one action, one accountable role, a due day and the evidence that will show it is done (rules CDRN-R5 and CDRN-R6).

      DueActionResponsible roleCompletion evidence

    What the example shows

    At 87 percent complete, the study looks close. The readiness view tells a different story: two dependencies are past or near their latest acceptable dates and QC demand exceeds the capacity available. None of that is visible in a completion percentage, because the remaining 13 percent is not average work. It is the work that depends on decisions and data the programming team does not control.

    The value of the method is the conversation it forces early: who owns each open item, by when it must be resolved, and what evidence will close it. Human judgment still decides what to do. For example, the team could agree to deliver topline without the late laboratory data and add it after lock. CDRN makes that a documented decision with a deadline instead of a surprise in lock week.

    Read Handbook chapter 6 for the full lock-readiness method and chapter 8 for writing dependencies and escalations someone can act on.