Protocol Deviation Analyst
Finds whether the sites are failing or the protocol is
7 of 12 deviations need follow-up; Site 104 Cairo stands out.
12 deviations across 5 sites. 7 are flagged for 12 severity points; the slowest was reported 12 days after discovery.
Review DV-02 first. 1 site(s) have at least twice the average number of deviations.
Whether a deviation affected patient safety or data integrity needs a clinical review: this only counts and times what is logged.
Why rows were flagged
- Site with unusually many deviations38%
- Reported late31%
- Major or critical31%
Value flagged by Site
- Site 104 Cairo5
- Site 201 Riyadh1
- Site 305 Dubai1
Deviations to review, most serious first
| Item | Site | Value | Days to report | Why |
|---|---|---|---|---|
| DV-02 | Site 104 Cairo | 3 | 12 | Reported late, Major or critical, Site with unusually many deviations |
| DV-01 | Site 104 Cairo | 2 | 9 | Reported late, Major or critical, Site with unusually many deviations |
| DV-04 | Site 104 Cairo | 2 | 7 | Reported late, Major or critical, Site with unusually many deviations |
| DV-07 | Site 201 Riyadh | 2 | 4 | Major or critical |
| DV-09 | Site 305 Dubai | 1 | 6 | Reported late |
| DV-03 | Site 104 Cairo | 1 | 4 | Site with unusually many deviations |
| DV-05 | Site 104 Cairo | 1 | 3 | Site with unusually many deviations |
What to do this week
- Review DV-02 with the site and the sponsor medical monitor first.
- Visit or retrain Site 104 Cairo: it has the most flagged deviations.
- Agree a reporting deadline of 5 days and track every deviation reported later.
Do
- Report every deviation within the protocol deadline, however small.
Don't
- Don't close a deviation without a root cause and a corrective action.
How to improve
- Add the corrective action date so the next report can show which deviations are still open.
- Add the number of subjects per site so the next report can compare rates, not only counts.
Demo
Overview
A clinical study generates deviations continuously: a visit outside its window, a procedure out of order, a sample handled incorrectly, an eligibility criterion applied loosely. Each is recorded, classified by whoever recorded it, and filed. Monitoring reviews them one at a time, and the standard report is a count by site.
A count by site answers almost nothing. Sites differ in enrolment, population and reporting honesty — and the site with the most deviations is frequently the one reporting properly, while the site with none is the one that worries an inspector.
The information is in the shape. Deviations concentrating on one protocol section point at a protocol that is hard to follow rather than careless sites, and if that is true, amending it fixes every site at once. Deviations clustering shortly after a site activates are a training problem with a known fix. Deviations rising after an amendment mean it was not absorbed. And the same deviation recurring after a corrective action closed means the action did not work — a finding about the response rather than the conduct.
This is deliberately narrow. It is an operational quality analysis: it makes no clinical or safety judgement, never assesses a participant, and never classifies anything as reportable. Those are regulated decisions with named accountability.
Benefits
The protocol fixed instead of the sites blamed
When the pattern says it is the protocol.
Training aimed where it works
At activation, where the cluster actually is.
Corrective actions that hold
Because recurrence after closure is finally visible.
What it does
Reads the protocol, not just the sites
Deviations concentrated on one section mean the protocol is hard to follow. Amending it fixes every site at once.
Normalises for enrolment and exposure
A raw count by site rewards the site that under-reports and penalises the one being honest.
Finds the post-activation cluster
Deviations concentrated in a site's first weeks are a training problem with a known fix.
Tests whether amendments landed
Deviations rising after an amendment mean it was issued and not absorbed.
Checks corrective actions actually worked
The same deviation recurring after an action closed is a finding about the response.
Makes no clinical or regulatory judgement
It never assesses safety, never assesses a participant, and never classifies anything as reportable. Those decisions carry named accountability.
What this changes
What this changes about your week
- It takes over
- Reading deviation patterns across a study rather than one at a time.
- Done today by
- A count by site, which rewards under-reporting.
- How often
- Reviewed individually; patterns never.
- Typical manual effort
- Normalising by exposure, then grouping by protocol section, activation date and amendment.
Why Pharma & Life Sciences in particular. Deviations concentrated on one protocol section mean the protocol is hard to follow — amending it fixes every site at once, where retraining nineteen sites would not.
Runs unattended
Started by you or by an event, and it finishes on its own. Nothing waits for someone to be at a desk.
The same standard every time
The two-hundredth item is held to the bar the first one was. Consistency is the part people cannot sustain.
It cannot act on its own
Protocol Deviation Analyst has no path to sending, spending or committing. That limit is why its output is safe to act on.
How it runs
This agent runs server-side through the PROMIVO runtime. Each run is logged step by step and every tool call is permission-checked before it executes.
- 1InputValidated against the agent input schema
- 2Modelclaude-opus-5 with automatic fallback
- 3Toolssearch_knowledge, extract_structured_data
- 4PermissionsRuns READ actions automatically; anything higher waits for approval
- 5OutputStructured result matching the output schema
- 6LoggingTokens, duration and every step recorded
Requirements
Integrations
No integrations required.
Before you start
- The deviation log with dates, sites, protocol sections and classifications
- The protocol and its amendments, in a knowledge base
- Site activation dates and enrolment by site
- Corrective actions with closure dates
- Requires the All-Access plan or higher
Use cases
Periodic quality review
The shape of deviations, not the count.
Before a monitoring visit
Which patterns to look at on site.
After an amendment
Whether it was absorbed or only issued.
Study close preparation
Recurring patterns an inspector would follow.
Pricing
All-Access
Billed monthly through your PROMIVO subscription. Cancel at any time.
Runs consume your plan allowance for agent executions and tokens. See plan limits
FAQ
Does it classify deviations as major or reportable?
No. Classification and reportability are regulated decisions with named accountability, and an agent making them would be doing something it cannot be responsible for. It reports patterns across the classifications you already assigned.
Does it assess participant safety?
Never. It makes no clinical or safety judgement of any kind. Where a pattern touches safety it stops and escalates without characterising it.
Does it see participant data?
It works from the deviation log, which is operational. It reproduces no participant identifier and reports nothing about any individual participant.
Reviews
Reviews open once customers have run this agent.
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