Bookcase

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My assigned cases, by stage

Unassigned cases waiting (any stage)

My case list

Case #ProductStageReport TypePriorityCreated

Filters

Case #ProductStageReport TypeAssignedCreated

Everything extracted from a source document is kept here as a case record. A record becomes a case, is added to a case as a follow-up, or stays here as rejected or duplicate.

Record #ProductStatusReport TypeCaseCreated

Where the automated workflow asks for a person: it says what it did, what it proposes and why it stopped. Approve to let that step go ahead; reject to stop the run.

Mail sent, or forwarded by a mail rule from your Outlook PV mailbox, to your intake address is read by the email agents. A report becomes a case record and the sender gets an automatic acknowledgement with the reference; anything else is set aside or passed to a person. Every message and what became of it is listed below.

ReceivedFromSubjectWhat it was judged to beOutcomeAcknowledgement

Choose, step by step, who does the work. Off: people do it. Review: the agent prepares it and a person confirms. Auto: the agent does it when it is confident enough, and the case is not one of the excluded kinds (pregnancy, paediatric, literature, death, serious unexpected). Anything not set is Review.

The agents

Every field and function belongs to one agent. Each case gets its own orchestrator and its own copy of every agent; an agent's workguide is what it has learned from people's decisions. Click an agent for its charter.

AgentVersionKindActive in stagesFieldsWorkguide
StepModeConfidence needed

Where product labels are kept

Used to decide whether an event is listed. Health Canada and DailyMed are searched by default; add a link or an internal folder for a product here.

ProductWhereLink / folderCountry

Multiple patients found in this document

This source describes more than one patient case. Select which one to build the case for.

New Case — Extract from Source Document

Where the event occurred. A product counts as yours only if its MAH permissions in the company product list cover this country.
Results will appear here.

▸ Paste extraction JSON manually instead

Import Case

Bulk import (e.g. E2B(R3) XML, CSV batch) is not built yet — this is a placeholder for that workflow. For now, use New Case to create cases one at a time from extraction output.

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Case

General
Patient
Product
Event
Analysis
Activities
Attachments
Regulatory Reports

Case Identification

Not a distinct E2B code. Saving fills this into any event below with no country set yet — it won't overwrite an event that already has a different one.
The initial version is always Initial. Only the follow-up rows below have a type.
Starts as this case's own number. Change it only when the case came from another sender: it then keeps that sender's identifier.
The one MedDRA version for every MedDRA Version element of this case (E.i.2.1a, D.7.1.r.1a, G.k.7.r.2a and the others).

Report Versions — Initial and Follow-ups

Version 1 is the initial report: its IRD and MRD are the fields above, and its Case Type is always Initial. Add a row for every follow-up, correction or amendment. Type and reason are E2B (C.1.11.1, C.1.11.2); each row's MRD is C.1.5 of that version. "Significant" is not an E2B field: it is used when the report for that version is generated. The E2B XML, CIOMS form and decoded view take a version's dates from its own row.

VersionType (C.1.11.1)IRDMRDReason (C.1.11.2)Significant

Literature Reference (C.4)

Study Identification (C.5)

Reporters (Primary Source — C.2)

Sender / Receiver (C.3)

Other Case Identifiers in Previous Transmissions (C.1.9.1.r)

Linked Reports (C.1.10.r)

The identification number of another report that is linked to this one (for example the report of a mother and of her child).

Patient Demographics

FDA Extended Patient Info (full identity, for direct consumer reports)

Medical History & Current Conditions (D.7)

Death Information (D.9)

Past Drug Therapy (D.8)

Drugs taken before this case's onset — distinct from Product tab drugs, which cover drugs taken during the case.

Parent Information (fetus/breastfeeding cases)

Parent Medical History (D.10.7)

Parent Past Drug Therapy (D.10.8)

Lab Data (F.r)

Drugs

Vaccines (G2.k)

Adverse Events

Click "Coding, Labelling & Causality" on an event to open its own dedicated view.

Narrative

Company Comment

Reporter's Comment

Abbreviated Narrative (PSUR Comment)

Overall Case Assessment

Routing / Workflow History

Action Items

Contact Log

Source Documents / References

File storage isn't wired in yet — this tracks references (filename + classification) only.

Regulatory Reports

Covers the core sections (identification, reporter, sender/receiver, patient, drugs, reactions, causality, narrative) — not yet every field in the schema. The CIOMS form is structurally faithful (box numbers, labels, section order) but not a pixel-exact copy of the printed template. Validate against the official ICH specs/CIOMS template before a real regulatory submission.