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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.


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Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software

Wednesday, June 17, 2020

Event date: 6/17/2020 Export event

Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software

Birds-of-a-Feather Webinar:  Agile Development for Clinical Research Software

Date:  Wednesday, June 17, 2020  Duration: One hour

Facilitator:  Alan Yeomans, Quality Manager, Viedoc Technologies AB

Open To: Staff from eClinical Forum member companies gratis. Member can get registration information by sending a note to webmaster3@eclinicalforum.org.  (If you are not an eCF member, please review the Membership tab on this website or contact info@eclinicalforum.org )

For This TopicAgile computing methods and tools are used in almost all software development today. Alan will address some of the key issues involved when using agile methods and tools for the development of clinical research software: 

• What is agile software development? 

• What are the advantages of agile development? 

• What should agile developers have when working with GxP software – in order to fulfil regulatory requirements? 

• How does a sponsor audit such a system? 

The theory behind how agile software development can be used for clinical research software will be followed with an example of a working development methodology incorporating agile methods and tools – how does a real software development organisation implement these methods and tools while maintaining regulatory compliance?

Time: This webinar will be offered twice so that all eCF members around the world will (hopefully) be able to join during a convenient time.

Webinar A:  Europe and Asia Pacific Facing -- UTC 0700

Webinar B: Americas and Europe Facing -- UTC 1600

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Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

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9/23/2020 UTC
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BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

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