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.
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.
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