The following ICH Expert Working Groups (EWG) and/or Implementation Working Groups (IWG) all work on the harmonisation of electronic standards:
- M2 EWG on the Electronic Standards for the Transfer of Regulatory Information (ESTRI)
- E2B(R3) EWG/IWG on the Electronic Transmission of Individual Case Safety Reports (ICSR)
- M8 EWG/IWG on the Electronic Common Technical Document (eCTD)
- M11 EWG on the Clinical electronic Structured Harmonised Protocol (CeSHarP)
Find links to related documentation below.
Information on the M2 EWG is available on the ICH website here.
ICH M2 Recommendations
Due to the information technology (IT) nature of the topic, some of the activities of the M2 EWG result in Recommendations. These Recommendations do not undergo the formal ICH step process in order to allow flexible change as both science and technologies evolve. They are agreed in the EWG, signed by all parties of the EWG, and are approved and signed off by the ICH Management Committee within the M2 Recommendation Notebook. The Recommendations page was last updated in August 2018.
Information on the E2B(R3) EWG/IWG is available on the ICH website here.
ICH E2B(R2) Message Specification and Q&A
The first Specification developed by the M2 EWG was the Individual Case Safety Report (ICSR), created as the electronic message for the ICH E2B(R2) Step 4 document version 4.4, Data Elements for Transmission of Individual Case Safety Reports. The Message Specification for the ICH E2B(R2) ICSR page was last updated on 25 October 2005. A revised specification was provided for public awareness on 26 June 2009. It was open for comment until 22 July 2009. A further revision to the specification was provided for feasibility testing on 26 July 2010. The ICH E2B(R2) page was last updated May 2018.
ICH E2B(R3) Implementation Guide and Q&A
An Implementation Guide for Electronic Transmission of Individual Case Safety Reports, ICH E2B(R3) Data Elements and Message Specification reached Step 4 of the ICH process for guideline harmonisation in November 2012, with further editorial corrections made by the E2B(R3) Expert Working Group for publication. ICH E2B(R3) is the first topic that involves collaborating with other Standard Development Organisations. The E2B(R3) Implementation Guide web page was last updated in August 2020.
Information on the M8 EWG/IWG is available on the ICH website here.
eCTD v3.2.2
The Electronic Common Technical Document (eCTD) created the electronic message for the Common Technical Document developed by the M4 EWG. eCTD v3.2.2 was created by the M2 EWG and is maintained by the M8 EWG/IWG. The eCTD page was last updated May 2024.
eCTD v4.0
The M8 EWG/IWG developed the eCTD v4.0 to improve robustness, flexibility and long-term stability of the message. The eCTD v4.0 page was last updated July 2025.
Study Tagging File
The Study Tagging File (STF) Specification is supplemental to eCTD v3.2.2 and is used organise study information. The STF was created by the M2 EWG and is maintained by the M8 EWG/IWG. The STF page was last updated May 2024.
Specification for Submission Formats for eCTD
The M8 EWG/IWG developed the "Specification for Submission Formats for eCTD" to implement the use of a harmonised file format for eCTD. The Submission Formats page was last updated June 2021.
Information on the M11 EWG is available on the ICH website here
ICH M11 Terminology
The Clinical electronic Structured Harmonised Protocol (CeSHarP) includes a set of terms and definitions that is published in collaboration with Clinical Data Interchange Standards Consortium (CDISC) and National Cancer Institute (NCI). These terms and definitions can be obtained from CDISC, NCI and ICH in different formats. The ICH publication of terms and definitions follows the ICH M2-recommended format Genericode and includes the ICH Object Identifiers for each code list that can be used for electronic data exchange.