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Difference between eSRA V2022 and eSRA V2021

Difference between eSRA V2022 and eSRA V2021

What is the difference between the eSRA Version 2022 and eSRA Version 2021?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2022 version. These updates are based on:

  • Updates and additions to the underlying regulatory authority documents as identified by the eClinical Forum Regulatory Advisory Group. A mapping between eSRA questions and eCF Requirements are in the document “Implementing eSRA: Sponsor Perspective”. Complete details of the eCF Requirements, including mapping to regulatory documents can be downloaded from www.eclinicalforum.org/downloads.
  • A desire to make the questions more concise and clear – based on feedback from users

What sites should complete an eSRA V2021?

  • All new sites
  • If a site with an existing completed eSRA updates their system to a new version
  • Sponsors should review differences between eSRA V2022 and eSRA V2021 to determine if they deem it significant enough to ask for existing sites to update (note: other than if a system is updated to a new version, the eSRA team does not think an updated eSRA is needed for V2022).

We are committed to continuing to improve eSRA. Please provide feedback via email to eSRA@eclinicalforum.org.

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«May 2022»
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27/04/2022
eCF BoF Webinar: Principal Investigator's Signature: Best Practices

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

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09/05/2022
Japanese translation of eSRA V2022

Japanese translation of eSRA V2022

Version 2022.1JP1 (10-May-2022)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

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17/05/2022 - 19/05/2022
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
18
17/05/2022 - 19/05/2022
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
19
17/05/2022 - 19/05/2022
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022

We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.

  • For those that can come to Brussels, you will benefit from us getting back to the networking and camaraderie of a face-to-face eCF meeting. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  
  • For those that prefer to participate virtually, there is a large choice of live streamed and recorded sessions that will be available for you to choose from and to engage with.
Read more
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