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WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


News from the eCF

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Regulatory Expert Group

The team provides expert evaluation of regulatory guidances from Europe, North America and Asia Pacific so that the impact on Clinical Research and eCF operations such as system criteria can be assessed. Consolidation of review comments via this group ensures that the eCF can respond efficiently to regulatory agency timetables for return of comments.

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

V2018PR March 2019 -- Webinar dates: April 15, 23

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.

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar
  • 218
  • Article rating: No rating

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

V2018PR March 2019 -- Webinar dates: April 15, 23

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.

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

Click title for more information

ECF REPRESENTATIVES MEET WITH EMA GCP IWG
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016
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FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

Re-Posted from eCF LinkedIn Group

The FDA and OHRP published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent. Expand the article to read more

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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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15
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
16
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

Read more
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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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