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eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

30-January-2023 at UTC 1500

Event date: 30/01/2023 Export event

eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

Birds-of-a-Feather Webinar:  Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

 

Date:  Monday, 30-Jan-2023      Duration: One hour

Facilitator:           Ronit Elshtein, MBA  (Global Site and Study Operations, Process and Standards Lead, Pfizer)

 

 

 

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:   The intention of this webinar is to introduce you to the newest eCF Site Assessment -- the draft eInvestigator Site File Questionnaire (eISFQ). Each question in the eISFQ is based on regulatory authority document statements. It is intended for sites to self-assess their eISF such that sponsors can determine if it is suitable to use for their regulated clinical trials. The eCF eISFQ Team intends to start a pilot with the the eISFQ in late 1Q '23. We would like to present this information to our members to get your feedback and to inspire interest in participating in the pilot.

Please note: The draft eISFQ is available for review/comment now until 20-Jan-2023.  If you are interested in participating in this review/comment, please send a note to eisfq@eclinicalforum.org . Thank you.

TimeWe apologize for the inconvenient time for our members in the Asia Pacific time zones. We will be recording the session, so if you are unable to attend, please register to receive the recording.  Please feel free to forward this invitation to your colleagues around the globe.

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )     

ECF MEMBERS CAN FOLLOW THIS LINK TO REGISTER:   eCF BoF Registration (eclinicalforum.org)

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eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

The intention of this webinar is to introduce you to the newest eCF Site Assessment -- the draft eInvestigator Site File Questionnaire (eISFQ). Each question in the eISFQ is based on regulatory authority document statements. It is intended for sites to self-assess their eISF such that sponsors can determine if it is suitable to use for their regulated clinical trials. The eCF eISFQ Team intends to start a pilot with the the eISFQ in late 1Q '23. We would like to present this information to our members to get your feedback and to inspire interest in participating in the pilot.

Read more
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eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic.  The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine

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