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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.
A follow-up exists, so the initial version's IRD and MRD above are locked. Case Type and the Nullification / Amendment reason follow the latest row below.
Version
Type (C.1.11.1)
IRD
MRD
Reason (C.1.11.2)
Significant
Not an E2B field. Used when the report is generated.
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
The initial version takes its dates from the initial version; a follow-up from its own row in the Report Versions grid.
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.
Proposed Change(s)
Review each proposal below. Nothing is saved until you click Apply on that item. To ask for something different, type below.
Revisions
One entry per explicit save. Click a revision to open a read-only view of the case as it was at that point.
Unsaved Changes Found
This is a local recovery copy from this browser only — it was never sent to the server. Restoring it will NOT save it either; you'll still need to click Save afterward.
Unsaved Changes
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Case Created
Click the case number to open it now, or close this to start a new intake.
No company product in this document
What's new
The changes made to Bookcase, newest first. The same list for every company.
Learned conventions
Rules for how the AI reads, codes and answers, learned from this company's users' chats. They apply to this company only and are written into this company's own skill files. A new rule needs one user; when users disagree, the answer with more distinct users wins (a tie keeps the current one); changing a rule in the base skills needs more than one user.
Conventions
Requests to change the application
New fields, dropdown options, layout changes and bug reports are not rules for the AI. They are filed here for the developers to implement.
Change log
Possible Similar Cases Found
Comparing product, event, patient details, and narrative against existing cases in your company. Use "Show Differences" on a match to see exactly what's new before deciding.
Pending Follow-up Information
New intake information was queued against this case. Review the differences below, then accept to apply them or dismiss to discard the proposal (the case itself is untouched either way until you choose).
Add Event
Enter the event term as reported (E.i.1.1a). It is coded to MedDRA automatically using AI-suggested search terms and the MedDRA dictionary.
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No exact MedDRA match — pick one
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