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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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«April 2019»
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

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3/27/2019 UTC
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Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

FacilitatorDavid Stein, D. Bartley Consulting

Opening StatementsJeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant

Duration: one hour (offered at UTC 1300 and UTC 1900)   Note: Sydney AU will be at 6am local time on 28-March.

(click on title for more information)

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4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
9
4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
10
4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
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4/15/2019 UTC
79

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

Read more
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4/16/2019 UTC
78

BoF Round-Table Discussion Webinar: ePRO Data Changes

Facilitator: Tom Haag, Cardinal Solutions Consulting

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.

click on title for more information

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4/23/2019 UTC
79

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

Read more
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