Electronic ISF – Remote eISF solution for superior clinical trials

An ISF contains essential documentation that shows that the clinical trials sites and investigators are adhering to the regulatory standards outlined by the ICH GPCP. According to the ICH GCP 4th edition, essential documentation includes “docu­ments which individually and collectively permit evalua­tion of the conduction of the study and the quality of the evidence produced.” All important documents must be submitted to the ISF within five working days of receiving them. These include any correspondence, reports, invoices, and contracts. They must be made readily available for inspection by the sponsor, its auditors, and regulators.

Examples of documents kept in an eISF

The investigator site file should include all relevant study documents, training documents, funding information, safety documentation, monitoring documents and more. Documents expected to be available for audit in the eISF are:

• Trial Protocol;
• Participant Information Sheet and Consent Forms;
• Investigator Brochure;
• Regulatory documents, applications and approvals;
• Delegation Logs;
• Safety Reports;
• Correspondence between delegated site staff and Sponsor;
• Pharmacy File;

Following the end of clinical trials and the closing of a clinical study, essential documents must be conserved following regulatory requirements. The industry standard is to keep eISF documents for 30 years to be accessed by monitors or regulators if needed.

The electronic Investigator Site File (ISF) is a subset of documents stored in the electronic Trial Master File (eTMF). The difference between the eTMF and the eISF is that the investigator site file is compiled individually by each trial site. The research sponsor can then gather ISF files from each trial site and compile them in the eTMF.

ETMF systems and the TMF reference model have been adopted industry wide, but there is no specific ISF model for sites: they still do not have precise, standardized filing structures. Removing paper ISF files and managing a site’s essential ISF documents electronically ensures a standard structure across all study sites.

In clinical trials, an Electronic Investigator Site File (eISF) is a secure digital platform for document collection and exchange activities. It ensures the seamless exchange of regulated research documents, which can be accessed from a central location, significantly reducing the administrative burden.

eISF, or Electronic Investigator Site File, is an electronic form of the traditional paper ISF. It allows for a more efficient, secure model for managing essential study documents, audit findings, and visit guidance records, facilitating compliant conduct of trials.

An electronic Trial Master File (eTMF) is an example of an electronic system that stores clinical trial documentation. It offers a secure, central repository for documents over time and enables seamless document exchange activities among stakeholders.

eISF presents multiple benefits, such as enhanced security, efficient document collection, reduced risk of mistakes, and streamlined communication between technology systems. It supports site-specific participant recruitment and provides a scientific quality standard for trial documentation.

While a paper TMF involves physical storage of documents and poses risks related to damage or loss, an eTMF is an electronic version that provides secure, accessible storage and exchange of regulated research documents over time. It also supports an independent network of clinical research teams.

A Clinical Trial Management System (CTMS) is a software system used to manage clinical trials, while eTMF is an electronic system that securely stores trial documents. Both work together to ensure efficient document collection and compliance with applicable regulations.

eTMF offers several advantages over paper TMF, including improved security, easy access to documents, seamless document exchange, reduced administrative burden, and compliance with primary regulations. eTMF also provides a comprehensive audit trail and facilitates efficient study startup processes.

An eTMF includes essential trial documents such as informed consent forms, audit records, training documentation, recruitment materials, and safety letters. These documents are required for the compliant conduct of clinical trials and are stored securely for easy access.

Traditional TMF can be associated with high administrative costs, risk of document loss or damage, lack of efficient document exchange activities, and difficulties in maintaining compliant conduct of trials. It may also pose challenges in maintaining an accurate audit trail.

eTMF is needed to facilitate secure and efficient document collection, ensure seamless exchange of trial documentation, and support compliance with regulatory requirements. It also allows for efficient study startup processes and easy access to documents for audits.

In clinical research, eTMF is an electronic system that securely stores and manages essential trial documents, including informed consent forms, audit records, and regulatory documents, supporting the compliant conduct of trials.

An Investigator Site File (ISF) contains documents specific to each trial site, while a Trial Master File (TMF) is a comprehensive record of all documents related to a clinical trial. An eISF or eTMF is the electronic form of these files, ensuring more efficient and secure document management