Clinera Patient Pools

Recruit Pool vs. Participant Pool

Screen failure is where most recruitment effort goes to die. Clinera Patient Pools segments active participants from candidates rejected or marked ineligible in screening, archives exactly which criteria they failed, and lets coordinators route them to the next trial they actually fit.

  • Pool Segmentation
  • Ineligibility Log
  • Cross-Study Re-Routing
  • Part 11 Audit Trail

The Screen-Failure Problem

Every Screen Failure Was Paid For Twice

A site spends the same referral, consent conversation and screening visit on a candidate who fails one criterion as on one who enrolls. Then that candidate disappears, and the next study starts recruitment from zero.

Lost Effort

Screen Fails Vanish

Failed candidates are closed with a reason code and never looked at again, even when another study needs that exact profile.

Data Quality

Reasons Live in Free Text

A note such as HbA1c too high cannot be searched, filtered or matched against another protocol inclusion criterion.

Manual Work

Sites Rebuild Lists by Hand

When a new trial opens, coordinators go back through paper screening logs and old spreadsheets to remember who might fit.

Two Pools, One Platform

Segment Active Participants From Re-Routable Candidates

Study planners keep the enrolled population clean while every screen-failed candidate is preserved with structured, searchable reasons.

Participant Pool

Enrolled and Active

Participants who passed screening and are progressing through visits. Scoped to the study and governed by the standard EDC workflow.

Recruit Pool

Rejected or Ineligible

Candidates referred or screened who failed criteria, held with the parameters they failed and the studies they could potentially be re-routed to.

Features

What Is Inside Clinera Patient Pools

Feature 1

Ineligibility Log

Flagged parameters are archived as structured data so coordinators can search the log when an upcoming trial eligibility profile matches what a candidate previously failed on.

  • Coded, not narrated - A failure is stored as a parameter such as an HbA1c threshold, not a comment.

  • Searchable by criterion - Filter the pool by failed parameter or match against an upcoming study eligibility profile.

  • Suggested re-routes - The record carries studies a candidate could potentially be routed to as new trials open.

Pool Schema

Ineligible Participants Queue - Recruit Pool Database Mapping

This is what a Recruit Pool record holds: de-identified by design, structured so failed criteria and re-route candidates can be queried like any other field.

Recruit Pool RecordJSON

{

"patient_code": "PUN-INL-0482"

"initials": "K.S."

"failed_inclusion": ["HB1AC_LEVEL_GT_6_5"]

"potential_re_route_studies": ["DIABETES-PHASE-3"]

}

patient_code

De-identified key

Site prefix, pool marker and sequence. The record is never keyed on name, DOB or MRN.

initials

Human-readable handle

A coordinator-friendly handle for cross-checking against site screening logs without exposing identity.

failed_inclusion

The reason as a parameter

A coded criterion such as an HbA1c threshold that can be filtered, matched and reported.

potential_re_route_studies

Where they might fit next

Study identifiers the candidate could be considered for as new protocols are configured.

How It Works

From Screen Failure to Second Chance

Step 1

Candidate Screened

Referral or walk-in reaches the site screening queue.

Screening

Step 2

Outcome Recorded

Pass moves to Participant Pool. Fail records specific criteria as coded parameters.

Pass / Fail

Step 3

Recruit Pool Entry

Failed candidate archived with code, initials, failed parameters and suggested studies.

Recruit Pool

Step 4

Coordinator Search

New trial opens; coordinator filters the pool by eligibility profile.

Matched

Step 5

Re-Route

Candidate moves into the new study screening queue, with action audited.

Re-Routed

Use Cases

Where Patient Pools Pays Off

Multi-Study Sites

Sites running several protocols in the same area can route a screen-fail into the next matching study.

Sponsor Portfolios

Sponsors with parallel Phase II and III programs recover screening spend across their own studies.

Master Protocols

Basket, umbrella and platform studies can route candidates across arms when criteria fit.

Academic and Registry Networks

Hospital research departments maintain a standing candidate pool for new investigator studies.

Why Clinera Patient Pools

Screening Data That Keeps Working

Structured

Reasons as Parameters

Failed criteria are coded fields, so a pool can be filtered by a new study inclusion profile in seconds.

One DB

Same Platform as Screening

The screening outcome that fails a candidate is the record that populates the pool.

Governed

De-Identified and Audited

Records are keyed by patient code, access is role-scoped and every re-route is written to the audit trail.

Specifications

At a Glance

Pools
Participant Pool for enrolled, active participants. Recruit Pool for rejected or ineligible candidates.
Record Fields
Patient code. Initials. Failed inclusion or exclusion parameters. Potential re-route studies.
Search
Filter by failed criterion, study, site and date range. Match against upcoming study eligibility profiles.
Re-Routing
Move a candidate into another study screening queue while preserving referral lineage.
Integrations
Clinera Recruit, Study Builder and EDC screening workflow.
Access and Compliance
Role-based access scoped by organization, study and site. 21 CFR Part 11 audit trail. HIPAA. GDPR.

FAQ

Frequently Asked Questions.

What is the difference between the Recruit Pool and the Participant Pool?+

The Participant Pool holds patients actively enrolled in a study. The Recruit Pool holds candidates who were referred or screened but rejected or marked ineligible.

What does the Ineligibility Log actually store?+

It archives a de-identified patient code, initials, failed inclusion or exclusion criteria as coded parameters, and studies the candidate could potentially be re-routed to.

Is patient identity protected in the Recruit Pool?+

Recruit Pool records are keyed by patient code and initials rather than full identifiers. Access is role-based and every lookup or re-route is audited.

How does re-routing to another study work?+

Coordinators search by failed parameter or new trial eligibility profile, then move matching candidates into that study screening queue.

Does Patient Pools work with Clinera Recruit physician referrals?+

Yes. Referrals that fail screening land in the Recruit Pool, and the referring physician link is preserved for future routed enrollment credit.

Next Step

Stop Starting Recruitment From Zero

Bring two protocols. We will show a screen-fail from one becoming a screening candidate in the other.