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V2025 vs V2024 and Regulatory Basis

V2025 vs V2024 and Regulatory Basis

Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements

eCF eSRA Release 2025 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA forms questions should be updated.

This document provides an easy look at the differences between the 2 eSRA Forms (Form/S for eSource and Form/F for eFile systems) as well as a comparison to the previous versions of each as well as a mapping to the underlying regulatory statements that support each eSRA question.

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«May 2025»
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eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
30
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
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1213
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
14
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
15
eCF Spring 2025 Workshops Announced

eCF Spring 2025 Workshops Announced

We are pleased to announce our 2025 Spring Workshops.

These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.

 April 8-10: Bangalore, India (kindly hosted by i2e)

April 29-May 1: King-of-Prussia, PA, USA   (kindly hosted by CSL Behring)

 May 13-15: Walton Oaks, Surrey, UK   (kindly hosted by Pfizer)

Read more
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