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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.
Birds-of-a-Feather Webinar & Discussion: Investigator Oversight on eCOA data - what is a good evidence?
Date: January 29, 2020 Duration: One hour
Facilitator: Cinzia Piccini, Eli Lilly
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org ) Members can contact webmaster3@eclinicalforum.org for registration information.
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: As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period. The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.
Time: This webinar will be offered twice so that all eCF members around the world will (hopefully) be able to join during a convenient time.
Webinar A: Europe and Asia Pacific Facing -- UTC 0800
Webinar B: Americas and Europe Facing -- UTC 1600
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New eCF ISF System Assessment!
eClinical Forum now has 2 FREE assessment forms for sites to self-assess their systems for use in regulated clinical trials. We are excited to release the first version of the “ISF System Assessment”. This assessment form is very similar to our eSource-Readiness Assessment (eSRA) and is, like eSRA, based on regulatory documents from regulators around the globe.
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eCF Spring Workshop in Ridgefield, Connecticut USA
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.