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CIOMS I Form - CIOMS

The CIOMS I Form provides a standardized format for reporting adverse drug reactions. It was developed in the 1980s by the Council for International Organizations of Medical Sciences (CIOMS) to facilitate international reporting of adverse drug reactions from pharmaceutical companies to regulatory authorities. The CIOMS I Form helped establish reporting standards and informed later guidelines from the International Council for Harmonisation, including formats for electronic transmission of safety reports. It remains a useful reporting format, though most electronic exchange now uses standards from the International Council for Harmonisation.

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876 views2 pages

CIOMS I Form - CIOMS

The CIOMS I Form provides a standardized format for reporting adverse drug reactions. It was developed in the 1980s by the Council for International Organizations of Medical Sciences (CIOMS) to facilitate international reporting of adverse drug reactions from pharmaceutical companies to regulatory authorities. The CIOMS I Form helped establish reporting standards and informed later guidelines from the International Council for Harmonisation, including formats for electronic transmission of safety reports. It remains a useful reporting format, though most electronic exchange now uses standards from the International Council for Harmonisation.

Uploaded by

sarbajit chakrabarti
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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1/5/2020 CIOMS I Form - CIOMS

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AREAS OF WORK PUBLICATIONS WORKING GROUPS STUDENTS

ABOUT CIOMS CONTACT (HTTPS://CIOMS.CH/CONTACT/)


CIOMS I FORM
USEFUL LINKS Home (https://cioms.ch) CIOMS I Form

World Health Organization (http://www.who.int/en/)

World Medical Association (https://www.wma.net)


The CIOMS I Form with links to the ICH E2B (R2 and R3) guidelines can be downloaded here
The United Nations Educational, Scienti c and Cultural Organization (http://en.unesco.org)
(https://cioms.ch/wp-content/uploads/2019/11/Fillable-Form_CIOMS-to-E2B.pdf).
International Society for Pharmacoepidemiology (ISPE) (https://www.pharmacoepi.org/)
In 1977, a CIOMS Conference on “Trends and Prospects in Drug Research and Development” recommended
that, by o ering anSociety
International independent forum, CIOMS
of Pharmacovigilance should facilitate discussion of policy matters between the
(http://isoponline.org)
research-based pharmaceutical companies and national regulatory authorities, and, when indicated
convene groups of experts to make recommendations on speci c issues.

In 1986, CIOMS set up its rst Working Group on pharmacovigilance, a Working Group on International
Reporting of Adverse Drug Reactions to exploreCIOMS
means of coordinating and standardizing international
adverse drug reporting by pharmaceutical manufacturers to regulatory authorities. Its agenda was limited
to post-marketing reporting of adverse drug reactions occurring in one country and which the
THE COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES
pharmaceutical industry should report to regulatory authorities in other countries where the drug is also
marketed. The Working Group devised a method 2019
for the reporting by manufacturers of suspected adverse
drug reactions which included standardized de nitions, procedures and format. The report contains the
CIOMS reporting Form 1, which for the rst time set the minimum standard for reporting. The CIOMS Form
1 was later the basis for establishing many of the national reporting forms.
CONTACT
The initial report of the Working Group was published in 1987, and the nal report of the CIOMS Working
Address: 1 Route des Morillons, Geneva
Group I “International Reporting of Adverse Drug Reactions” was published in 1990. In 1992 the CIOMS
Phone: Group II report 
Working +41“International
(0) 22 791 64 97Reporting of Periodic Drug-Safety Update Summaries” was
E-mail: [email protected] (mailto:[email protected])
https://cioms.ch/cioms-i-form/ 1/2
1/5/2020 CIOMS I Form - CIOMS

published. Since then more than ten Working Groups, including the recent two Working Groups dealing
with vaccine safety have completed their work creating an extremely valuable set of pharmacovigilance
guidance documents.

The impact of CIOMS Working Groups on Global development pharmacovigilance has been substantial.
Several ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use) guidelines, such as E2A, E2C, E2D and E2F, were based on the work of respective CIOMS
Working Groups (see also the CIOMS Newsletter of June 2016).
ICH was established in 1992, and in 1996 it started developing the ICH E2B guideline to harmonize
international electronic transmission of Individual Case Safety Reports (ICSRs), i.e. to standardize the data
elements for the transmission of all types of ICSRs, regardless of source and destination. This includes case
safety reports for both pre-approval and post-approval reporting periods and covers both adverse drug
reaction (ADR) and adverse event (AE) reports. Today, most electronic exchange of ICSRs uses the ICH E2B
standard. Since the CIOMS I form is a reporting form, not primarily intended for electronic exchange
between databases, linking the CIOMS I form to E2B can be helpful.

USEFUL LINKS
World Health Organization (http://www.who.int/en/)

World Medical Association (https://www.wma.net)

The United Nations Educational, Scienti c and Cultural Organization (http://en.unesco.org)

International Society for Pharmacoepidemiology (ISPE) (https://www.pharmacoepi.org/)

International Society of Pharmacovigilance (http://isoponline.org)

CIOMS

THE COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES

2019

CONTACT

Address: 1 Route des Morillons, Geneva

Phone: +41 (0) 22 791 64 97

E-mail: [email protected] (mailto:[email protected])


https://cioms.ch/cioms-i-form/ 2/2

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