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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.

 

NEWS FROM THE ECF

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

Offered 2 times on either Feb 25 or Feb 26 2020

Event date: 2/25/2020 - 2/26/2020 Export event

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

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

Date/Time: This Webinar is offered at 2 times in order to accommodate participants from around the world.  Please note that depending on your location, the webinar date is either Tues Feb 25 or Wed Feb 26.
Duration: One hour

Webinar A (Americas/Europe Facing): Tuesday Feb 25 at UTC 1500 (California 7am, Denver 8am, Chicago 9am, NYC 10am, Brazil noon, UK 3pm, Western Europe 4pm, Eastern Europe 5pm, Mumbai 8:30pm)

Webinar B (Americas/APAC Facing): Feb 26 at UTC 0200 ( California: Tues Feb 25 at 6pm, Denver: Tues Feb 25 at 7pm, Chicago: Tues Feb 25 at 8pm; NYC: Tues Feb 25 at 9pm; India: Wed Feb 26 at 0730, China/Singapore: Wed Feb 26 at 1000, Japan: Wed Feb 26 at 1100, Sydney: Wed Feb 26 at 1300)

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

To register for this free webinar, please follow this link:  https://www.surveymonkey.com/r/eCF_Sponsor_eSRA  --- PLEASE NOTE: WE WILL USE YOUR EMAIL ADDRESS FOR SUPPLYING INFORMATION FOR THIS WEBINAR AND NOT FOR ANY ADVERTISING

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BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.

We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.

Facilitated by Carmen Jiménez, Eli Lilly

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ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

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Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

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This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.  This is a joint work by the eClinical Forum and EUCROF.

 

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Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”

Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.

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