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Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

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Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment) 31
Jan
2024

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

V2024

Regulatory documents used as a basis for the eClinical Forum Site Assessment Forms (eSRA and ISF Assessment)

Release 2024 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). In particular, this version incorporates updates from the EMA Guideline on computerised systems and electronic data in clinical trials (Sep 2023). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA or ISF Assessment questions should be updated.

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Author: Suzanne Bishop (Americas Administrator)
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