Clinical / Platform intelligence + Operational intelligence

Deterministic first. Reviewed always.

INNOVIZZ Clinical homeClinical Practice Home
ContactBook a Call
Explore
Practice
Clinical Overview →

Solutions in Practice / INNOVIZZ Insights

One Amendment.
A Clearer Review.

A protocol amendment arrives. Your team must trace what changed, check related specifications and explain what needs attention. Follow a Data Management review from a revised passage to a documented next action.

For Data Management and biometrics teams coordinating amendment review.

Explore the Walkthrough Explore INNOVIZZ Insights

Clinical Document Intelligence / Six Scenes

See the Change.
Follow the Evidence.

In study INS-DEMO-026, a protocol amendment widens the Visit 6 window from ±3 to ±5 days. Inspect each review step at your pace, or play the walkthrough.

INNOVIZZ InsightsSample Study / INS-DEMO-026

Explore the Review Steps. Follow the source, inspect the proposed impact and record a review decision.

01 / The Question

The Protocol Changed.
Where Do We Start?

A data manager needs to understand an amendment before coordinating downstream review. The question is specific: what changed at Visit 6, and could the edit-check specification need attention?

What This Helps WithTurn a broad document search into a focused review question.
Data Management ReviewOriginal INNOVIZZ interface illustration

The Review Question

“What changed at Visit 6, and which edit check may need review?”
INS-DEMO-026Protocol amendment
Start HereVisit 6 → Window → Edit-check specification

One named question. Selected source versions. A reviewer remains responsible for the interpretation.

02 / The Selected Versions

Know Which Documents
You Are Comparing.

The reviewer selects protocol 2.0 and amendment 3.0, the selected versions for this review, plus edit-check specification 1.4. The source register keeps that context attached to the review.

Why It MattersA clear version pair prevents an answer from drifting into the wrong document context.

Selected Sources / INS-DEMO-026

Baseline

Protocol

2.0

PROT-026
§6.2 · p. 42

Approved in scenario
Amendment

Protocol

3.0

PROT-026
§6.2 · p. 44

Approved in scenario
Edit-check specification 1.4ECS-026 · §4.3 · p. 18 · Current selected reference

The approved version pair is deliberately selected. “Newest file” alone does not establish the governing source.

03 / The Source-Linked Change

The Window Widens.
The Source Stays Visible.

Section 6.2 identifies the Visit 6 window in both versions. The nominal visit day remains Day 84; the permitted window changes from ±3 to ±5 days. The passages make the numerical difference inspectable.

What the Reviewer GainsSee the exact change without reconstructing it from a summary.
PROT-026 / Schedule of Assessments

§6.2 · Table 2 · Visit 6

Protocol 2.0 · p. 42

Visit 6: Day 84 ±3 days

Baseline passage
Protocol 3.0 · p. 44

Visit 6: Day 84 ±5 days

Amendment passage

Identified difference: Visit window widened by two days on each side. Nominal Day 84 is unchanged.

Inspect the Sample Protocol Passages

INS-DEMO-026 / PROT-026 / §6.2 / Table 2

Version 2.0, p. 42: “Visit 6: Day 84 ±3 days.”

Version 3.0, p. 44: “Visit 6: Day 84 ±5 days.”

These prepared excerpts illustrate one selected difference. They do not establish that all protocol changes or downstream impacts have been found.

04 / The Potential Impact

A Related Check
May Need Attention.

The selected specification still refers to a ±3-day threshold. That suggests a review item for EC-V06-014. Study context, date definitions and amendment implementation must be checked before deciding whether to change it.

The Useful BoundaryA source-supported proposal starts a review. It does not validate an edit-check change.
Protocol 3.0 · §6.2 · p. 44Visit 6: Day 84 ±5 days

ECS-026 / Version 1.4 / §4.3 / p. 18

EC-V06-014

Flag Visit 6 if the actual visit date is outside Day 84 ±3 days.

Potential Impact / ProposalReview the ±3-day threshold against the amended ±5-day window.

The wording suggests a relationship. It does not prove the rule must change or that this is the only affected item.

Inspect the Sample Check Source

ECS-026 / Version 1.4 / §4.3 / p. 18

EC-V06-014: “Flag Visit 6 if the actual visit date is outside Day 84 ±3 days.”

Reference: protocol 2.0, §6.2, Table 2, p. 42. Compare with protocol 3.0, §6.2, Table 2, p. 44.

No check logic has been executed or changed. Other study definitions and implementation conditions are outside these prepared excerpts.

05 / The Reviewer Decision

The Evidence Informs.
The Reviewer Decides.

The data manager assesses the proposed impact with the study team. Accept it for follow-up, request more context, or reject the suggestion. Your choice updates the final packet in this illustration.

What Stays with the TeamAccountability for interpretation, follow-up and any approved change.

Sample Review Item / INS-REV-006

Visit 6 Window Review

Identified change
Day 84 ±3 → ±5 days
Source pair
PROT-026 · 2.0 / 3.0 · §6.2
Proposed impact
Assess EC-V06-014 · ECS-026 1.4
Decision owner
Data manager with the study team

No review disposition selected. Nothing is sent or approved in a real system.

06 / The Review Handoff

Less Searching.
A Clearer Next Step.

A source-linked packet keeps the evidence, proposed impact and reviewer disposition together. The next person can start with the relevant passages and next action, instead of reconstructing the amendment story.

The Intended BenefitLess searching and rebuilding context. More attention on the decision that needs expertise.
Discuss a Document Review Pilot Explore INNOVIZZ Insights

Sample Review Packet / INS-REV-006

The Context Travels
with the Finding.

  1. 01
    Selected Sources

    PROT-026 2.0 / 3.0 · ECS-026 1.4

  2. 02
    Change + Proposed Impact

    Visit 6: ±3 → ±5 days · Assess EC-V06-014

  3. 03
    Reviewer Disposition

    Awaiting reviewer decision

  4. 04
    Next Action

    Data manager to review the proposed impact.

Nothing is exported, sent or approved in a real system. A pilot would agree the packet, review process and acceptance criteria with your team.

All choices stay in this page and clear on Reset or reload. This walkthrough does not assess completeness of impact detection or clinical validation.

Read the Walkthrough
  1. Question. A data manager asks what changed at Visit 6 and which edit check may need review for INS-DEMO-026.
  2. Versions. The selected register contains protocol PROT-026 versions 2.0 and 3.0, both approved in the scenario, plus edit-check specification ECS-026 version 1.4.
  3. Change. Protocol §6.2, Table 2 changes Visit 6 from Day 84 ±3 days in version 2.0, p. 42, to Day 84 ±5 days in version 3.0, p. 44. The nominal day remains unchanged.
  4. Potential impact. ECS-026 version 1.4, §4.3, p. 18 defines EC-V06-014 with a Day 84 ±3-day threshold. Reviewing it against the amendment is a proposal, not a validated change.
  5. Review. The data manager can accept the proposal for follow-up, request revision or reject it. No choice approves a real study change.
  6. Handoff. The illustrated packet keeps selected versions, source passages, the proposed impact, reviewer disposition and corresponding next action together. Without a choice, it remains awaiting reviewer decision. Nothing is sent or exported.

The Useful Outcome

Keep the Context
with the Finding.

The intended benefit is less time rebuilding the amendment story at each handoff. The next reviewer can inspect the selected sources, understand the proposed impact and decide what happens next.

Illustrative Record Structure

What the Review Packet Contains

Selected Versions
The protocol pair and related specification, with document identifiers and source locations.
Supporting Passages
Before-and-after wording that lets the reviewer inspect the identified change.
Potential Impact
The related item that may need attention, with its source and rationale for review.
Decision and Next Action
The reviewer's disposition, responsible owner and agreed follow-up.

This describes the sample packet shown in the walkthrough. It is not a generated report or an export of your session.

Where the Working Day Could Improve

Finding the Relevant Wording

Repeated searches across versions become a review of the selected passages and their document context.

Explaining Why an Item Matters

A disconnected comment becomes a proposed review item with the change and supporting rationale alongside it.

Passing the Work On

The next owner receives the review context and decision, reducing the need to reconstruct them from messages.

A pilot should test these benefits against your current process, including the effort needed to check the results.

From Review to Follow-up

Give the Next Owner
Something to Act On.

When a reviewer accepts an item for follow-up, its source references and decision can form the starting point for an issue in your existing process. Your team still authorizes any specification or study-system change.

Explore Biometrics Issue Management
  1. 01 / Insights Review

    Inspect the Finding

    Selected sources, identified change and potential impact.

  2. 02 / Reviewer Decision

    Agree the Follow-up

    Record the disposition, owner and next action.

  3. 03 / Receiving Workflow

    Track the Resolution

    Handle assignment, comments and revisions through your agreed issue process.

Separately scoped handoff. The receiving system, fields and permissions would be agreed with your team. This illustration does not create or transfer an issue.

Your First Engagement

Start with One
Amendment Review.

Bring a recurring review problem and the person who owns it. We will define a pilot your team can assess before considering a wider implementation.

Discuss a Document Review Pilot Review the Offering and Deliverables

For the first conversation: describe the document types, current review steps and main handoff difficulty. No study documents are needed at this stage.

  1. 01

    Choose a Defined Review

    You identify an amendment pair, one related specification and a named reviewer. Together we confirm document readiness and the permitted processing environment.

  2. 02

    Agree What to Evaluate

    We scope the workflow and test it against reference examples agreed with your study expert. Assess source support, material misses, unsupported suggestions and total review effort.

  3. 03

    Make an Informed Next Decision

    Your team receives the agreed review-packet format, evaluation findings and operating guidance, then decides whether to refine, expand or stop.

Scope, reviewer involvement, timing and fees are agreed in writing before work begins.

Back to Clinical Solutions in Practice