The eClinical Forum is happy to announce the Members-Only release of the “eCF Requirements”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.
We will hold 2 webinars to introduce the “eCF Requirements” such that we can accommodate member’s time zones around the globe as well as upcoming national holidays.
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements.
The eCF Requirements are being released to eCF Members Only. Those who register for the webinar will be sent a copy of the eCF Requirements. Additionally, they will be available to those with a un/pw to the Members section of www.eclinicalforum.org
Birds-of-a-Feather Webinar: Requirements for Electronic Data for Regulated Clinical Trials (eCF Requirements)
Facilitator: Alan Yeomans, PCG Alan is a member of the eCF REG team.
Webinar A: Americas/Europe Facing --- Tuesday, March 27 at UTC 1500
Webinar B: Europe/Asia Pacific Facing – Tuesday, April 17 at UTC 0800
Duration: One hour
For registration, members please contact Suzanne.Bishop@eClinicalforum.org . If you are not a member and would like information on our membership, please see the membership tab on this website and/or contact firstname.lastname@example.org and we will be happy to set up a phone meeting to discuss all-things-eClinical Forum with you!