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

Wed, 10-March-2021 at UTC 09:00 and UTC 16:00

Event date: 10/03/2021 Export event

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

Birds-of-a-Feather Round Table Discussion:  Practical Considerations when implementing eConsent

Date:  Wednesday 10-March-2021   Duration: 1.5 hour  (usually eCF BoFs are one hour long – this time, there is so much information to present and discuss, we will meet for 1.5 hours)

Presenters:   Fiona Maini, Medidata and Mika Lindroos, Signant Health

Open To: Staff from eClinical Forum member companies gratis

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:   This webinar introduces the eCF and EUCROF Implementation 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.

Some of the topics addressed in the presentation include:

  • Implemention guide review
    • Introduction and recap on eConsent
    • Decoding the ‘electronic’ in eConsent
    • COVID-19 - the eConsent catalyst
    • Stakeholder perspectives, patient, site, sponsor
    • Implementation Considerations such as:
    • Process: what will you do differently with eConsent?
    • Practical implementation considerations
    • Financial considerations
    • Regulatory landscape updates

Time – this webinar is offered at 2 times (UTC 09:00 and UTC 16:00), both on Wed, 10-Mar-2021. It will run for 1.5 hours. We hope you will find one of them convenient for your participation.

Registration -- eCF members, please contact suzanne.bishop@eclinicalforum.org. If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

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Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

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.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA 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 systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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