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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 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:  Site experience in the day-and-age of hybrid e-trials

eCF Birds-of-a-Feather Webinar:  Site experience in the day-and-age of hybrid e-trials

Back by popular demand!  Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed!  Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.

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