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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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«October 2024»
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EU Hybrid Workshop Announced

EU Hybrid Workshop Announced

Registration is open! Our EU Hybrid Workshop will be kindly hosted by Boehringer Ingelheim at their offices in Ingelheim am Rhein, Germany on October 15-17 2024.

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EU Hybrid Workshop Announced

EU Hybrid Workshop Announced

Registration is open! Our EU Hybrid Workshop will be kindly hosted by Boehringer Ingelheim at their offices in Ingelheim am Rhein, Germany on October 15-17 2024.

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17
EU Hybrid Workshop Announced

EU Hybrid Workshop Announced

Registration is open! Our EU Hybrid Workshop will be kindly hosted by Boehringer Ingelheim at their offices in Ingelheim am Rhein, Germany on October 15-17 2024.

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eCF Americas Autumn Workshop 2024 Announced

eCF Americas Autumn Workshop 2024 Announced

Registration is open!  Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.

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23
eCF Americas Autumn Workshop 2024 Announced

eCF Americas Autumn Workshop 2024 Announced

Registration is open!  Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.

Read more
24
eCF Americas Autumn Workshop 2024 Announced

eCF Americas Autumn Workshop 2024 Announced

Registration is open!  Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.

Read more
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