"This is the best use of my time to remain current with what is going on in the industry."
WHO WE ARE
The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
The eClinical Forum has conducted a global survey of investigational site experiences and expectations with EDC. The survey covers: * Computer use and site facilities. * Current experience with EDC. * Satisfaction with EDC features. * Future expectations. 840 completed questionnaires were returned by both EDC-experienced (52%) and EDC-naïve (48%) investigators. The results show: * In the EDC-experienced population, over 40% of current trials use EDC. * Although there are significant differences between continents, investigators are very computer literate with even 20-30% of EDC-naïve investigators using Email and Internet several times a day. * Investigators find data entry a burden that should ideally be shifted to other site staff. * Despite investigators wanting to improve the speed of data entry, only 13% of data is first entered into the eCRF. The main opportunity to improve speed of entry lies in avoiding duplication of entry into both EDC and patient records. * Gaps exist between investigator need and level of satisfaction with speed of communication, tools for study management, direct data transfer and resources for data entry. * Most EDC-experienced investigators consider that EDC should be used for all trials, and over 50% of investigators say that the availability of EDC will positively affect their decision to participate in trials. The results show certain interesting issues and trends that the eClinical Forum will continue to explore.
NOT A MEMBER?
Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023
The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.
eCF APAC Autumn Workshop 2024 Announced
Registration is open! Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.