CIOMS form: the CIOMS I fields, when it is used, and how E2B(R3) carries it

The CIOMS form, almost always meaning the CIOMS I form, is a one-page report titled "SUSPECT ADVERSE REACTION REPORT" that carries a single adverse reaction case from a company to a regulator. It is published by the Council for International Organizations of Medical Sciences, which set up its first Working Group on pharmacovigilance in 1986. Its numbered items fall into four blocks: reaction information, suspect drug information, concomitant drugs and history, and manufacturer information. US regulation still names it: under 21 CFR 312.32(c)(1)(v), a sponsor may submit a foreign suspected adverse reaction on a CIOMS I form instead of a Form FDA 3500A.

The form matters now mostly because its data elements became the shape of everything that replaced it. When a case moves electronically as an individual case safety report under ICH E2B(R3), it is carrying the same facts the paper blocks ask for.

What the CIOMS I form asks for, field by field

The four blocks and their printed items, as the form prints them.

I. Reaction information

Item	Printed label
1	Patient initials (first, last)
1a	Country
2	Date of birth (day, month, year)
2a	Age (years)
3	Sex
4 to 6	Reaction onset (day, month, year)
8 to 12	Check all appropriate to adverse reaction
7 and 13	Describe reaction(s) (including relevant tests and lab data)

The boxes under items 8 to 12 are the seriousness criteria: patient died; involved or prolonged inpatient hospitalisation; involved persistent or significant disability or incapacity; life threatening; congenital anomaly; other medically important condition. Those six outcomes are what make a case serious, which is a separate question from how severe it was. How serious differs from severe works through the distinction.

II. Suspect drug information

Item	Printed label
14	Suspect drug(s) (include generic name)
15	Daily dose(s)
16	Route(s) of administration
17	Indication(s) for use
18	Therapy dates (from and to)
19	Therapy duration
20	Did reaction abate after stopping drug? (yes, no, NA)
21	Did reaction reappear after reintroduction? (yes, no, NA)

Items 20 and 21 are dechallenge and rechallenge, and they carry more weight than their two lines suggest. Both appear as scored criteria in the formal causality scales such as WHO-UMC, Naranjo and Kramer, so whether the site recorded what happened when the drug stopped often decides how the case is assessed.

III. Concomitant drugs and history

Item	Printed label
22	Concomitant drug(s) and dates of administration (exclude those used to treat reaction)
23	Other relevant history (e.g. diagnoses, allergies, pregnancy with last menstrual period, etc.)

Item 22's exclusion is easy to get wrong. A drug given to treat the reaction is not a concomitant suspect, and listing it reads as though the patient was already taking it when the event began.

IV. Manufacturer information

Item	Printed label
24a	Name and address of manufacturer
24b	MFR control no.
24c	Date received by manufacturer
24d	Report source (study, literature, health professional, regulatory authority, other)
25a	Report type (initial, follow-up)
26 and 26a	Name and address of reporter (include ZIP code)

The block also carries the date of this report and the original report number. Item 24c is the one a reporting clock is counted from, because it records when the company first received the case.

When a sponsor files a CIOMS form for an expedited report

The format of a US IND safety report is set by 21 CFR 312.32(c)(1)(v): "The sponsor must submit each IND safety report in a narrative format or on FDA Form 3500A or in an electronic format that FDA can process, review, and archive." The same paragraph allows a CIOMS I form in place of a Form FDA 3500A for foreign suspected adverse reactions, and requires every notification to FDA to be prominently identified as an "IND Safety Report".

Whichever form carries it, the case has to be recognisable as a case first. ICH E2A sets the minimum: an identifiable patient, a suspect product, an identifiable reporter, and an event identifiable as serious and unexpected with a reasonable suspected causal relationship. Below that threshold there is nothing to report yet, and the sponsor follows up to reach it.

FDA's electronic submission requirement has since narrowed where paper applies. Since April 1, 2026, reports under 312.32(c)(1)(i) go electronically to the FDA Adverse Event Monitoring System using the E2B(R3) standard, and noncommercial INDs such as investigator-sponsored and expanded access INDs are exempt. The deadlines and the day-zero rules that govern all of it are set out in IND safety reports under 21 CFR 312.32.

How E2B(R3) carries the same report electronically

E2B(R3) is the ICH standard for the electronic transmission of individual case safety reports. Its implementation guide defines the data elements and the message specification, and ICH constrained the ISO/HL7 individual case safety report standard to produce it, so the electronic case is a structured message rather than a scan of a page.

CIOMS supports the move directly: it publishes a fillable CIOMS to E2B form that maps the paper items onto the electronic elements. The mapping is the useful way to think about the relationship. A reporting team filling item 13 and a team populating the reaction section of an E2B message are answering the same question with different tooling.

One element deserves naming because it reaches back into the site record. FDA's regional implementation guide for E2B(R3) asks for the MedDRA Lowest Level Term, recorded as its numeric code, where possible. A free-text reaction description satisfies item 13 on paper; the electronic report wants the coded term beside it.

What the paper form asks	What the electronic report needs
Item 13, describe reaction(s) in free text	The same description, plus the reaction coded as a MedDRA term
Items 4 to 6, reaction onset date	A structured onset date, so duration can be computed
Items 20 and 21, dechallenge and rechallenge	The same two answers, as coded values
Item 24c, date received by manufacturer	The receipt date that starts the reporting clock

Sources: CIOMS I form and FDA's regional implementation guide for E2B(R3).

What a complete case report asks of the clinical record

For a sponsor safety team, this is label work. Attribution and coding settled accurately during the trial are what put the right warnings, dosing intervals and monitoring schedule on the label at approval, and finding the same signal afterwards costs a label change and a safety communication instead. Every field above that carries real information comes out of the clinical record at a site: the onset date, the description with its relevant tests, what happened when the drug stopped, the concomitant medicines, the relevant history.

Two of those are where cases stall. The reaction description has to be precise enough to code, because "rash, worsening" cannot be mapped to a term or compared against the brochure, which is the comparison reference safety information governs. And attribution has to be scored per drug with its reasoning available, which is unstable work: a recurring adverse event's attribution changes between visits for the same patient in 31 to 36% of cases (Hillman et al., JCO 2010). In a combination regimen the question is asked once for every drug, as multi-drug attribution in combination regimens sets out. Coding consistency across sites is what then makes the aggregate readable, which is the subject of MedDRA coding and signal detection.

How Burna AI records what a case report is built from

Burna AI works on the site side of this path, where the term, the attribution and the evidence are produced.

• Every adverse event in a note is graded against the CTCAE version the protocol names, v5.0 or v6.0, with the MedDRA Lowest Level Term assigned, so the coded term the electronic report wants arrives with the graded event. Look a term up at ctcae.ai.
• Each event is scored for attribution against every drug in the regimen using the WHO-UMC and Kramer algorithms, with the reasoning shown, which is the material behind items 20 and 21.
• Every grade traces to the line in the medical record that produced it, and a grade whose citation set is incomplete is flagged before it is signed.
• A grade becomes a record when a qualified investigator signs it with a 21 CFR Part 11 electronic signature, and the signature carries what was accepted, what was overridden and the citation set as signed.
• The platform produces FDA MedWatch, IRB and serious adverse event reports from the graded record, as the dated capability record lists.

Building the CIOMS form or the E2B(R3) message, and deciding what gets reported, belong to the sponsor's safety team. What changes is the state the case arrives in: a coded term, an attribution with its reasoning, and a citation for both. AI suggests, clinicians decide. Human-in-the-loop, always.

Common questions about the CIOMS form

Is the CIOMS form still used?

Yes, in defined places. US regulation still permits a CIOMS I form for foreign suspected adverse reactions in place of a Form FDA 3500A, and the form remains in use for exchanges between companies and partners. Most routine expedited reporting to agencies now travels electronically as an E2B(R3) individual case safety report.

What is the difference between a CIOMS form and Form FDA 3500A?

They serve the same purpose with different origins. Form FDA 3500A is FDA's own MedWatch form for mandatory reporting; the CIOMS I form is the international format published by CIOMS. 21 CFR 312.32(c)(1)(v) treats the CIOMS I form as an acceptable substitute for a foreign suspected adverse reaction.

How many fields does the CIOMS I form have?

Its items run from 1 to 26 across four blocks, with lettered subdivisions such as 1a, 2a and 24a to 24d, and two items sharing one free-text area for the reaction description. The seriousness criteria sit together as a single block of check boxes numbered 8 to 12.

Is a CIOMS form the same thing as an ICSR?

An individual case safety report is the content, and the CIOMS I form is one container for it. The same case can be an E2B(R3) message instead, which is why CIOMS publishes a CIOMS to E2B mapping.

Who fills in the CIOMS form?

The company holding the case completes it, from information the reporter supplied. At a research site the investigator reports the serious event to the sponsor with a causality assessment, and the sponsor's safety team builds the report that goes to the agency.

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The AI platform for accelerated clinical research, from first-in-human trials through postmarket surveillance. Burna AI performs automated adverse event grading and attribution in real time, providing clear rationale and audit-ready evidence, including generation of IRB, sponsor and FDA reports. Burna AI delivers CTCAE v5 and v6 grades and MedDRA LLT codes on every encounter; enabling standardization, cross-site consistency and accuracy of clinical research data. AI suggests, clinicians decide. Human-in-the-loop, always.

If your cases arrive needing a query before they can be coded, we can show you what a graded, cited and signed event looks like on arrival: book a 15-minute conversation.