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 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.
May 22, 2023
Wednesday may 24 TELEMEDICINE TECHNOLOGIES will be present at SantExpo on the OVHcloud stand as a partner of the “Open Trusted Cloud” program. Our president Yoani Matsakis will be representing Telemedicine Technologies, and wil intervene next to Mathieu Godart, CTO and co-founder of SÊMEIA and Emmanuel MEYRIEUX, Client Security manager at OVHcloud. Throughout the day you […]
May 22, 2023
Fierce Biotech The FDA seems to be satisfied that Pfizer’s RSV vaccine is safe and effective for administration in pregnant women to protect infants from severe disease. The agency’s confidence was revealed in briefing documents filed ahead of an advisory committee meeting set for Thursday. The Vaccines and Related Biological Products Advisory Committee will consider […]
May 22, 2023
Trial Site News The World Health Organisation (WHO) decided Thursday May 4, 2023, to end the COVID-19 public health emergency of international concern (PHEIC). TrialSite cautions that this is a provisional (temporary) status while WHO considers its forward-looking options (2023-2025). Importantly, in “The COVID-19 Emergency is Over, Sort of,” TrialSite reports that in America some […]