DISCOVER
eISF
THE ELECTRONIC INVESTIGATOR SITE FILE
The eISF, or electronic Investigator Site File, is the digital version of the paper-based investigator site file (ISF). It enables the collection in digital form of essential documents that demonstrate a clinical trial was conducted in accordance with Good Clinical Practice (GCP) guidelines, as well as regulatory and sponsor requirements. These documents include the protocol, informed consent forms, study reports, lab results, and other documentation related to the trial.
Leads to this page
The eISF is stored in a secure, web-based system that is accessible to authorized personnel only
The use of eISFs has several advantages over paper-based ISFs :
• efficiency in document management
• increases accuracy and completeness of data
• enhances security of sensitive information
• facilitates remote monitoring of study sites
• real-time data access and sharing between sites, sponsors, and regulatory agencies
Theuse of eISFs represents a significant step forward in the conduct of clinical research, enabling faster and more efficient trial management while ensuring compliance with regulatory and ethical standards.
LATEST NEWSOUR NEWS >
June 27, 2024
25 September 2024 from 4:00PM to 5:30PM (CEST) Webinar Overview It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the […]
June 27, 2024
Applied Clinical Trials Online ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial intelligence (AI)? Lacroix: There is a lot of opportunity across the life cycle to assist with this and it’s interesting because historically it was always: we want to throw people at some of […]
June 27, 2024
Fiercebiotech Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years prior to launch. This strategy should focus on addressing the nuanced market access challenges for such treatments, including but not limited to, distribution network design, tailored commercial site engagement, […]