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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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BoF Round-Table Discussion Webinar: ePRO Data Changes

April 16 at UTC 13:00

Event date: 4/16/2019 Export event

BoF Round-Table Discussion Webinar: ePRO Data Changes

Birds-of-a-Feather Round-Table Discussion:  ePRO Data Changes: How do we ensure Data Integrity and GCP Compliance?

Date:  Tuesday April 16 2019  Duration: One hour - starting at UTC 13:00

Facilitator: Tom Haag, Cardinal Solutions Consulting

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic:  

The use of ePRO in clinical studies presents an interesting challenge when data recorded by patients and site staff needs to change from initial entry. To the uninitiated, it would be logical to assume that once data is entered, it is never changed. Or at the very least, the data is cumulatively recorded in 21 CRF Part 11-compliant audit trails. This interactive discussion will focus on the data integrity and custody controls required by regulators, for changes that occur more often that we might think.

Webinar Discussion Questions (please come prepared to discuss)

  1. How and where do you define the handling of changed data in ePRO for your trial?
  2. Do you deny changes to ePRO data (by the patient and/or site), and if so how and where is this described for your trial?
  3. What controls are in place to delineate fraud from data entry errors, and how to you manage recall bias?

Registration: Please send a note to webmaster3@eclinicalforum.org 

 

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9/9/2020 UTC
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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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