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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)

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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eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

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eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

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2
eCF Spring Workshop in Ridgefield, Connecticut USA

eCF Spring Workshop in Ridgefield, Connecticut USA

Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.

Read more
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