Updated Participant Status Lifecycle - August 2026

Last updated: August 5, 2026

In August 2026, Chloe delivered an update to its Participant Status Flow, offering the following benefits:

  • Clearer visibility - See exactly where every participant sits in the lifecycle, at a glance.

  • Cleaner datasets - Standardized withdrawal reasons make exits consistent and easy to audit.

  • Explicit enrollment - Enrollment is tracked in its own right, with or without randomization.

  • No Disruption - Your data migrates automatically. Nothing changes in how your study runs.

Every participant moves through one continuing path (green). Some exit early (red); a couple of states sit before the study begins (amber). The revised Participant Status Lifecycle is structured as follows:

chart.jpg

Below are definitions for each of the states appearing in the lifecycle diagram.

Pending / Entry

  • Not Started - Added by an org user; skips qualification.

  • Incomplete Qualification - Started the qualification form, not yet finished.

Continuing

  • Qualified - Met the qualification criteria. (Qualified Date)

  • Consented - Intake complete. (Start + Projected End Date)

  • Enrolled - Active in the study. (Enrollment Date)

  • Completed - Reached projected end, forms done. (Actual End Date)

  • Closed-Out - Record finalized by the team. (Close-Out Date)

Exited

  • Not Qualified - Did not meet criteria. (Disqualified Date)

  • Screen Failed - Failed screening; message auto-sent if enabled. (Screen Fail Date)

  • Withdrawn - Left the study; reason required. (Withdrawn Date)

  • Deleted - Admin-only removal, outside the flow via data change request.

There are three significant enhancements to the workflow that come with this update.

  1. A true "Enrolled" status.

  2. Standardized withdrawal reasons

  3. Completed vs. Closed out

Status: Enrolled

Participants who are actively in the study now have their own status, with or without randomization.

  • Its own status.  “Enrolled” now clearly marks participants who are actively in the study, no more guessing from “Consented.”

  • Randomized studies.  Participants are automatically randomized when they are enrolled in a study with randomization enabled.

    • “Randomized” now displays as “Enrolled.”  Same meaning, more flexibility. If a participant is Enrolled, they are in the study, and you can still see their randomization group.

  • Non-randomized studies.  You can now enroll participants directly, even when randomization is turned off.

Standardized Withdrawal Reasons

Withdrawing requires picking a reason from a common list, so exits are consistent and audit-ready.

  • Withdrawing a participant now requires selecting a reason from a standard list. Reasons are captured directly on the participant: cleaner data, consistent exits, and audit-ready reporting for sponsors.

  • Bulk withdrawals from the participant list apply the same reason to everyone selected.

Reasons for withdrawal:

  1. Adverse Event

  2. Death

  3. Investigator's Decision

  4. Lack of Efficacy / Treatment Failure

  5. Lost to Follow-Up

  6. Non-Compliance

  7. Participant Decision

  8. Pregnancy

  9. Prohibited Medication Use

  10. Protocol Deviation

  11. Sponsor Decision / Study Terminated

  12. Withdrawal of Consent

  13. Other (with write-in)

Completed vs. Closed-Out

Finishing the protocol and finalizing the record are now two distinct, trackable steps. Two distinct end states let us separate “finished the protocol” from “record reconciled and locked.”

  • Completed - Set automatically when a participant reaches the study’s projected end date AND all their accessible forms are completed or expired. Actual end date is stamped.

  • Closed-Out - The study team’s final confirmation that the participant’s record is fully reconciled and done. Close-Out Date is set by the team.

Added Guardrails for Data Quality

This updated provides a number of guardrails that enhance data quality.

  • Enrolled locks out Screen Fail - Once a participant is enrolled, “Screen Failed” is no longer an option, so you can’t fail someone who is already in.

  • Study status stays separate - Changing a study’s status never changes a participant’s status. The two are independent.

  • Close-Out follows Completed - “Closed-Out” only becomes available after a participant is Completed, so records finalize in the right order.

  • No blank exits - Withdrawing always requires a reason, so every exit is explained and reportable.