Introduction
This eBook, Long-term Retention of the Investigator Site File, has been developed to provide clarity and practical guidance on the regulatory requirements that govern ISF retention, the roles and responsibilities involved, and the best practices that sites can adopt to remain compliant. It draws on industry standards and regulations, while also addressing the real-world challenges faced by research sites as the volume and complexity of trial documentation continue to grow.
At Arkivum, we specialise in long-term digital archiving and preservation, helping organisations securely manage critical data for decades. With this eBook, our goal is to support sites, including those within the NHS in understanding not just what is required, but how to implement sustainable and compliant practices for ISF retention.
By the end, readers will have a clear overview of the expectations, risks, and solutions available, enabling them to safeguard trial documentation, maintain regulatory compliance, and ultimately support the delivery of high-quality clinical research.
What is an Investigator Site File?
In clinical research, maintaining accurate and organised documentation is important to ensure compliance, patient safety, and the integrity of study data. One of the most important components of this documentation is the Investigator Site File (ISF).
The Investigator Site File is a collection of essential documents that are held at the clinical trial site by the Principal Investigator (PI) or designated study staff. Its purpose is to demonstrate that the site is conducting the study in accordance with regulatory requirements, the study protocol, and Good Clinical Practice (GCP) guidelines. Essentially, the ISF provides a complete record of the trial at the site level.
The Investigator Site File is a collection of essential documents that are held at the clinical trial site by the Principal Investigator (PI) or designated study staff.
Key Purposes of the ISF.
Regulatory Compliance
The ISF contains all documentation required by regulatory authorities and ethics committees, allowing them to verify that the trial is conducted legally and ethically.
Audit and Inspection Readiness
During audits or inspections by sponsors, regulatory agencies, or independent monitors, the ISF serves as evidence that the site is properly managing the trial.
Study Protocol and Amendments
It ensures the Principal Investigator and study staff have all necessary documents readily available to manage the study efficiently.
Typical Contents of an ISF.
While the exact contents may vary depending on the sponsor and study requirements, the ISF generally includes:
- Essential Regulatory Documents: Ethics committee approvals, regulatory authority correspondence, and investigator agreements.
- Study Protocol and Amendments: The approved protocol and any changes made during the study.
- Informed Consent Forms: Copies of all versions signed by participants.
- Investigator and Staff Qualifications: CVs, training certificates, and delegation logs.
- Study Correspondence: Communications with the sponsor, monitors, and ethics committees.
- Safety Reports: Documentation of adverse events and serious adverse events (SAEs).
- Trial Supplies and Equipment Records: Logs for investigational products, storage conditions, and accountability.
