Check out the resources below to find out how the eSource Initiative aims to help clinical trial sponsors address clinical research challenges and drive efficient data gathering practices to benefit patients, sites and sponsors.
Well-thought-out practices and procedures for the collection and retention of non-CRF data are crucial to maintaining data accuracy and integrity. To guide the development of such practices and procedures, this paper outlines certain high-level best practices related to handling and managing non-CRF data. These are high-level suggestions, as the purpose is to share learnings to enable more efficient/effective use/adoption of eSource. The suggestions can be tailored to each company’s individual circumstances. These considerations can also help companies to address or reduce challenges that they have encountered and/or to initiate discussions to help improve processes.
The paper was published in DIA’s peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS) and discusses that guidance and standards have been in place for some time, however data collection methods and technology have not been utilized to their fullest capability, and transcription between paper and electronic systems continues to be the norm. The Initiative’s intent is to facilitate the industry’s movement toward optimal usage of electronic data sources.
This Landscape assessment provides insight into sponsor company eSource activities and the environment affecting eSource adoption based on input from TransCelerate Member Companies, standards organizations, and regulatory authorities.