eCF BoF Webinar: Requirements for Electronic Data for Regulated Clinical Trials (eCF Requirements)
The eClinical Forum is happy to announce the Public 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.
Date/Time: This webinar is offered at 2 times in order to accommodate participants from around the world.
Webinar A: Asia Pacific Facing – Monday, April 15 at UTC 0500 (UK 06:00, Western Europe 07:00, Eastern Europe 08:00, India 11:30, China, Singapore & Perth 13:00, Japan 14:00, Sydney 15:00)
Presenter: Greg Gogates, eCF REG Team, CRF Bracket
Webinar B: Americas/Europe Facing --- Tuesday, April 23 at UTC 1400 (California 7am, Denver 8am, Chicago 9am, NYC 10am, Brazil 11am, UK 15:00, Western Europe 16:00, Eastern Europe 17:00, India 19:30)
Presenter: Jules Mitchel, eCF REG Team, Target Health
Duration: One hour
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 systems that manage data which will become part of a regulated clinical trial are consistent with regulatory requirements.