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Birds-of-a-Feather Discussion: Audit trail reviews to ensure data integrity

March 15 2017, Registration required

Event date: 3/14/2017 Export event

Birds-of-a-Feather Discussion: Audit trail reviews to ensure data integrity

Birds-of-a-Feather Discussion: Audit trail reviews to ensure data integrity

Date: Wednesday March 15 2017       Duration: One hour

Time: UTC 1400; 15:00 CET, 10:00 AM EST, 10:00 PM Singapore. We apologize for the inconvenient time in some regions.

Facilitator: Cinzia Piccini, Eli Lilly & Co, Spain

Open To: Staff from eClinical Forum member companies

Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic and are participative discussions, not presentations.  All participants are encouraged to share information and ask questions. Any member can participate that has an interest in the topic area. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic: The following questions will be discussed. If you have additional discussion questions for this topic, please type them in during your registration.

Description: According to Part 11, audit trails need to be available and convertible in a generally intelligible form, allowing regular reviews and copying by the agency. With the recent release of data integrity guidelines across GxP, audit trail reports are becoming a common request during GCP regulatory inspections. For GMP, Annex 11 dictates regular audit trail reviews; in GCP this is a non-written expectation as its content might help identify data anomalies and/or data integrity signals.

This is not a presentation but rather an open discussion:  How much review of audit trail records is necessary? What are good practices, tool and education needs to perform a well-defined review? What is the focus of a review by the sponsor and by the agency?  All questions and comments are welcome.

What You Need to Do: Register using the linkhttps://www.surveymonkey.com/r/Audit_Trail_Reviews

What Happens Next: We will send out access instructions several days before the event to those who have registered.


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2/11/2020 UTC

eSRA: Can Your Site Electronic Health Record Systems (EHR) be Used to Source Clinical Research Data?

This presentation on the eClinical Forum's eSRA (eSource Readiness Assessment) will be given by Martijn Griep, eClinical Forum Representative & Associate Director, Janssen, The Netherlands. It will be on Feb 11, 2020 at 15:00

More information on this conference can be found at: https://eucrof-conference.eu/programme/  

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Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool

Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

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  • Benefits of all sites and all sponsors and all CROs using a common assessment tool
  • The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
  • The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
  • How a Sponsor/CRO can incorporate eSRA into their processes
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Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool

Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

  • What the Sponsor’s responsibility is regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities
  • Benefits of all sites and all sponsors and all CROs using a common assessment tool
  • The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
  • The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
  • How a Sponsor/CRO can incorporate eSRA into their processes
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