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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.
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
Our grand vision is to set the standard for processes and to make a difference within the clinical trials industry. Being members of the eClinical Forum is a key component in this strategy.
Mats KlaarViedoc Technologies
Through the network of eCF, direct exchange with regulators is possible and allows us to discuss and provide inputs into new guidance.
John SmithBoehringer Ingelheim
The CTU/section for Data Management at Oslo university hospital was approved for certification according to the ECRIN standards in July 2019. One of the tools used for the requirements for data capture tools was the eCF “Requirements for Electronic Data for Regulated Clinical Trials".
Cecilie MoeOslo University Hospital
".. the best use of my time to remain current with what is going on in the industry."
"... a group of professionals that not only recognize and discuss challenges, but actually drive strategic direction"
"... the best, most productive and informative group I have worked with in a long time.."
