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.
In Guidance for Industry Electronic Source Data in Clinical Investigations, eSource is defined as “data initially recorded in an electronic format is considered eSource. This can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” The Site Capability Questionnaire is intended to help capture the site’s use of technology during the site qualification process that is conducted prior to the start of a study. The intent of this form is to facilitate the reduction of any administrative burden on Investigative Sites by collecting information in a consistent way across multiple sponsor companies–reducing the duplicative completion of similar forms across multiple studies.
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.