Biometrics Issue Desk
Track a finding through sponsor and CRO comments, a revised delivery and the reviewer’s decision.
Inside the Example
- Record a Finding
- Assign & Discuss
- Review a Revision
Clinical / Workflow Demonstrations
Clinical Solutions
in Practice.
Explore working examples, visual walkthroughs and sourced public study summaries. Follow the inputs, checks and reviewer decisions, then consider the workflow your team needs.
For Clinical buyers evaluating the review method
The Collection / 09 Examples
Choose the Workflow
You Want to Inspect.
Start with a task your team recognises. Each example shows the review process and what the team receives.
Review & Programming
Follow the finding, inspect the change and see what the reviewer receives.
Catalyst QC Walkthrough
Follow a population error from a candidate table to failed checks, a rework decision and a blocked release.
Inside the Example
- Candidate Table
- Comparison Checks
- Reviewer Decision
TLF QC Example
Inspect the inputs, a flagged comparison and the records a QC reviewer needs to document a decision.
Inside the Example
- Source & Rules
- Flagged Difference
- Review Record
SDTM Mapping Example
Trace source metadata through mapping rules, an unresolved proposal and a standards reviewer’s decision.
Inside the Example
- Source Metadata
- Mapping Proposal
- Standards Review
INNOVIZZ Insights Walkthrough
Follow a sample protocol amendment into a source-linked review item, a data-manager decision and an assigned handoff.
Inside the Example
- Compare Versions
- Inspect the Impact
- Record the Decision
Platforms & Review
Explore how study context, platform workflows and human decisions connect.
Clinical Visual Studio
Explore sourced aggregate trial summaries and separate sample subject profiles, with visit context visible.
Views to Explore
- Public Study Summary
- Sample Profiles
- Domain Views
Spotfire Linked Review
Filter a sample cohort, select a laboratory observation and follow the linked subject history.
Inside the Example
- Filter a Cohort
- Mark an Observation
- Follow the Subject
SAS Workflow
Inspect a proposed code change and follow execution, scheduling and reporting in an illustrated SAS workflow.
Inside the Example
- Code Proposal
- Execution & Checks
- Scheduled Output
Governed Agent Workflow
Follow a missing visit date through checks, a proposed question and a policy gate before human review.
Inside the Example
- Missing Date
- Proposed Question
- Human Review
Have a Similar Workflow?Use an example to frame the scope, review requirements and deliverables for your team.
Plan Your Next StepINNOVIZZ / Motion study · 24 seconds
A Sample Clinical Review Example.
Watch the clinical review sequence, then inspect the working examples and their limitations.
Original INNOVIZZ motion design · Silent film with on-screen labels · Sample demonstration
Read the film transcript
Screening to follow-up: bring visits, liver laboratory measurements and adverse events onto one review timeline. Inspect the source, document the question and leave the clinical decision with the reviewer.
Clinical / Visual walkthrough
From a Table to a Reviewable Record.
Follow a synthetic QC comparison through four checkpoints. The animation explains the working pattern; it does not run a QC engine.
INNOVIZZ / ClinicalWorkflow Walkthrough
Chapter 1 of 4 · paused
01 / 04
Begin with a Reproducible Cut.
Name the datasets, shell, program and rules before comparing an output.
01 / SOURCE
The Input Record
- Study
- SYN-001
- Datasets
- ADAE · ADSL
- Data cut
- DEMO-CUT-01
02 / DEFINITION
The Comparison Contract
- Shell
- TEAE summary
- Rule set
- DEMO-RULES-01
- Acceptance
- Named QC reviewer
02 / 04
Make the Discrepancy Visible.
Independent derivation and explicit tolerances give the reviewer a precise difference to investigate.
Cell-level comparison
| Measure | Expected | Candidate | Review |
|---|---|---|---|
| Any TEAE, n | 112 | 114 | Flagged |
| Illustrative row B | 57 | 57 | Matched |
| Illustrative value C | 14.2 | 14.3 | Flagged |
A difference opens a review. It does not establish the cause.
03 / 04
A Finding Needs a Disposition.
The QC lead establishes whether the issue is in production, independent QC, the specification or an accepted difference.
FINDING / 001
Two Subjects Differ
- Expected
- 112
- Candidate
- 114
- Difference
- +2 subjects
HUMAN CHECKPOINT
Awaiting a Reviewer
- Cause
- Not established
- Disposition
- Pending
- Production release
- Not authorized
04 / 04
Keep the Decision with the Work.
Inputs, versions, comparisons and the named disposition belong in the engagement record. This storyboard creates no real packet.
Illustrative evidence structure
01Source manifestInputs and version references
02Comparison recordValues, rules and exceptions
03Review recordDecision, reason and reviewer
04Release gateAcceptance required before use
Source → comparison → reviewer decisionSelect a chapter or play at your pace.
Clinical / Visual walkthrough
The Study, Brought Into View.
Follow a sample subject from a laboratory observation to a review question and a saved snapshot.
INNOVIZZ / ClinicalWorkflow Walkthrough
Chapter 1 of 4 · paused
01 / 04
Bring the Domains Onto One Timeline.
Demographics, exposure, events and labs should be read in the context of one subject.
Synthetic subject / SYN-001
One Subject. One Timeline.
Swipe or scroll to see Screening through Visit 6
Visit Sequence / Schematic Spacing
● Illustrative lab trend━ Exposure│ Event
No clinical interpretation or treatment recommendation.
02 / 04
Put Context Behind the Flag.
A reviewer needs source references, refresh timing and an agreed rule, not just a bright status color.
ILLUSTRATIVE LAB FLAG
Review the Source
- Subject
- SYN-001
- Visit
- Visit 4
- State
- Review required
REVIEW CONTEXT
Know What the View Represents
- Data cut
- DEMO-CUT-01
- Rule owner
- Named study reviewer
- Interpretation
- Human judgment
03 / 04
See Which Site Needs Attention.
Protocol-specific views bring indicators together; they do not make a clinical decision.
Synthetic oversight / four sites
A Flag, with Its Context.
Invented indicator values. Thresholds must be defined and validated for the study.
04 / 04
Freeze the View for the Review.
Versioned snapshots and role-separated access matter when preparing committee materials.
A controlled review package
01Data cutRecord the source and refresh
02Open / closed viewsSeparate permissions at the data layer
03SpecificationTest the agreed display and rules
04AcceptanceNamed reviewers accept the view
Subject → source context → review snapshotSelect a chapter or play at your pace.
01 / The Comparison
Inspect a Difference
and Its Review Record.
An illustrative table comparison, from a flagged cell to a reviewer’s record. Explore the example below.
Synthetic comparisonIllustration only · no validation engine connected
| Measure | Reported | Re-derived | Check |
|---|---|---|---|
| Illustrative value A | 28.0 | 28.0 | Match |
| Illustrative value B | 14.2 | 14.3 | Mismatch |
| Illustrative value C | 7.5 | 7.5 | Match |
Open the illustrative reviewer record
Finding
Value B differs by 0.1. This example does not infer why.
Review state
Pending reviewer assessment. A flagged cell is not a signed-off result.
Record
Synthetic comparison retained with the reported value, re-derived value and review state.
The reviewer determines the cause and records the disposition.
See the TLF QC serviceThe Working Brief
What to Look for in a Pilot Record.
Use these examples to identify the records your team would need from a pilot on your own workflow.
01 What to Ask for in a Commissioned Pilot
Inputs and Versions
Identify the datasets, specifications, programs and candidate outputs used. Retain the agreed version and data-cut references so the run can be reconstructed.
Checks and Findings
Show the checks executed, their results and any incomplete steps. Link a discrepancy to the compared values, rule, supporting evidence and reviewer disposition.
Acceptance Decision
Record the acceptance criteria, reviewer, unresolved limitations and approved exceptions. Test reproducibility and failure behavior on your own inputs before accepting the scoped workflow.
Clinical / Your Next Decision
Turn an Example into a Pilot Question.
Choose the workflow you want to examine. Use the conversation to define suitable inputs, success criteria and the evidence your team would need before accepting it.
Built for Your Team to Operate.
Receive the agreed source or configuration, specifications, test records and operating handover. The statement of work identifies client-owned deliverables, existing INNOVIZZ methods, third-party licenses and support terms.