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The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by the World Health Organization (WHO) and UNESCO in 1949, based in Geneva, Switzerland. In pharmacovigilance it is best known for the CIOMS I form, the single-page suspected adverse drug reaction report that became a reference template for expedited case reporting. The ICH E2A guideline on clinical safety data management names CIOMS-I among the precedents behind its list of minimum information for expedited reports.
Clinical research teams build safety surveillance around Good Clinical Practice (GCP) standards, plan adverse event collection in the clinical trial protocol design, and keep registration duties in view through clinical trial registration and reporting compliance.
What is CIOMS and who runs it?
As described on the official CIOMS site on November 7, 2026, CIOMS represents a substantial part of the biomedical scientific community through member organizations that include biomedical disciplines and national academies of sciences. It is in official relations with WHO and is an associate partner of UNESCO. Its work covers research and policy topics including ethics, medical product development and safety, and it carries out that work through expert working groups.
CIOMS does not enact legislation. Its working group reports are consensus documents that regulators and industry draw on. The CIOMS site lists current and former working groups under areas of work such as bioethics, pharmacovigilance and product development.
What is a CIOMS I form?
The CIOMS I form is the product of CIOMS Working Group I, whose 1990 publication is titled “International Reporting of Adverse Drug Reactions”. It standardised how a suspected adverse drug reaction for a single patient is reported. Today such a report is known as an individual case safety report (ICSR).
The content of an expedited report is described in ICH E2A, whose list of minimum information is grouped under these headings:
- Patient details: initials or another identifier, gender, age or date of birth, weight and height.
- Suspected medicinal product(s): brand name, international non-proprietary name, batch number, indication, dosage form and strength.
- Other treatment(s): concomitant medicinal products and non-medicinal therapies.
- Details of the suspected adverse drug reaction(s): a full description, the criterion for regarding the report as serious, onset and stop dates, dechallenge and rechallenge information, setting and outcome.
- Reporter details: name, address, telephone number and profession.
- Administrative and sponsor or company details: source of the report and the date the sponsor first received it.
For trial events that meet the definition of a Suspected Unexpected Serious Adverse Reaction (SUSAR), expedited reporting follows the ICH E2A clinical safety data management definitions and standards.
Who uses CIOMS-style reporting?
ICH E2A frames expedited reporting as a duty of the sponsor of a clinical investigation or the holder of a marketing authorization, and the reporting clock is counted from the sponsor’s first knowledge of a qualifying case. Investigators report serious events to the sponsor and, where local rules require it, to their ethics committee or institutional review board.
How does expedited reporting work?
ICH E2A describes the logic in four stages, which CIOMS-style reports serve:
- Intake: a case is received and recorded.
- Check of minimum criteria: an initial report can be submitted when four elements are present: an identifiable patient, a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and, in clinical investigation cases, has a reasonable suspected causal relationship.
- Assessment: seriousness, expectedness against the applicable product information (for an unapproved product, the Investigator’s Brochure) and causality are judged.
- Submission and follow-up: the report is sent within the prescribed time, and follow-up information is sought actively and submitted as it becomes available.
What are the reporting timelines?
The following periods come from ICH E2A, as published on the ICH website and checked on November 7, 2026. National and regional rules may add or vary requirements, so teams confirm the rules of each authority they report to.
- Fatal or life-threatening unexpected reactions: notify regulators as soon as possible and no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days.
- All other serious, unexpected reactions: file as soon as possible and no later than 15 calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.
Periodic, aggregate safety reporting during development is handled separately, in the Development Safety Update Report (DSUR).
Common mistakes
- Starting the clock at the wrong date: E2A counts from first knowledge by the sponsor, not from the date of an internal medical review.
- Incomplete case descriptions: leaving out onset dates, dechallenge or rechallenge information, or outcome, which E2A lists as expected content.
- Judging expectedness against the wrong document: E2A ties expectedness to the applicable product information, such as the Investigator’s Brochure for an unapproved product.
- Treating an initial report as the end of the case: E2A states that follow-up information should be actively sought and submitted as it becomes available.
How do the CIOMS working groups relate?
| Group or document | Convened by | Topic |
|---|---|---|
| CIOMS Working Group I | CIOMS | International reporting of adverse drug reactions (CIOMS I form, 1990) |
| CIOMS Working Group VIII | CIOMS | Signal detection |
| CIOMS Working Group IX | CIOMS | Risk minimisation |
| CIOMS Working Group XVI | CIOMS | Development Safety Update Report |
| ICH E2A | ICH | Clinical safety data management: definitions and standards for expedited reporting |
FAQ
What does CIOMS stand for?
It stands for the Council for International Organizations of Medical Sciences, established jointly by WHO and UNESCO in 1949.
What is a CIOMS I form used for?
It is a standardised report of a suspected adverse drug reaction in an individual patient, the output of CIOMS Working Group I, used to pass case information to regulators and other parties.
What is the difference between CIOMS and ICH?
CIOMS is an international, non-governmental, non-profit organization that convenes expert working groups. ICH is the International Council for Harmonisation, which publishes technical guidelines for pharmaceuticals, such as E2A.
What are the minimum criteria for a valid expedited report?
ICH E2A lists an identifiable patient, a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and, in clinical investigation cases, has a reasonable suspected causal relationship.
How fast must a fatal or life-threatening unexpected reaction be reported?
Under ICH E2A, no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by a complete report within 8 additional calendar days. Other serious, unexpected reactions are due within 15 calendar days.
Sources
All sources checked on November 7, 2026.
- Council for International Organizations of Medical Sciences (CIOMS). Home page, About CIOMS and working group listings. https://cioms.ch/
- CIOMS. Former Working Groups. https://cioms.ch/former-working-groups/
- CIOMS Working Group I. “International Reporting of Adverse Drug Reactions” (1990). https://cioms.ch/publications/product/international-reporting-of-adverse-drug-reactions/
- International Council for Harmonisation (ICH). “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A).” https://database.ich.org/sites/default/files/E2A_Guideline.pdf
