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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

The eClinical Forum is pleased to announce that their eSource-Readiness Assessment (eSRA) Handbook v2021 has been translated to Japanese. While the eSRA questionnaire is still required to be completed in English, the Japanese translation of the eSRA Handbook includes an official Japanese translation of the eSRA questions.  The Handbook in Japanese can be downloaded below.

In addition, we are offering a webinar, in the Japanese language, on the use of eSRA. This was presented in September 2020. 

The link to the webinar recording in Japanese:  https://transcripts.gotomeeting.com/#/s/bed8f2c17e0541399da3d76318c799cc178ef9efd07b9c64b8f3799ca7531637

eSRA questionnaire is updated annually in the first quarter, based on updates to regulatory authority documents.

As always, if you have any questions pertaining to eSRA, please submit to eSRA@eclinicalforum.org

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eClinical Forum は、このたび eSource-Readiness Assessment (eSRA) Handbook v2021 の日本語版を作成致しました。eSRA questionnaire は英語でご回答いただく必要がありますが、eSRA HandbookにはeSRA questionnaireの各設問の正式な日本語訳を載せています。日本語版Handbookは画面下部の <Documents to download>からダウンロードできます。

eSRAの使い方について2020年9月に日本語でWebinarを実施しており、その録画は https://transcripts.gotomeeting.com/#/s/bed8f2c17e0541399da3d76318c799cc178ef9efd07b9c64b8f3799ca7531637 からご覧いただけます。

eSRAは、規制当局の規制・ガイダンスの変更に対応するために毎年第一四半期に改訂されます。

eSRAに関するご質問は、eSRA@eclinicalforum.orgにお寄せください。

Documents to download

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«April 2021»
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eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

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Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

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eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

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REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
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REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
6
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
7
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
8
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
9
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021

We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more

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