The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"

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, NMPA, MHRA 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 source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

The current technology landscape is becoming more unsustainable for research sites, who are inundated with cubbies of paper binders and a growing number of systems to manage. At the same time, sponsors want to work more efficiently with sites without adding to their already heavy workload.  In this one-hour webinar, eClinical Forum member, Veeva, will show how sites and sponsors are saving time, reducing redundant work, and working together by using Veeva’s connected technology for improving the site-sponsor relationship.