Investigator Site Files Summit – Investigator Site Files Summit

Inspections of clinical trial site documentation by regulatory authorities can happen at any time. Inspectors review the ISF (investigator site file) or regulatory binder as part of their inspection. Failing to maintain the clinical trial documentation can result in major or even critical findings, which have negative impacts on the site, the study and the sponsor. Since the ISF contains all of the documentation associated with the clinical trial — such as protocol and signature pages, investigator information, IRB-related documentation, laboratory certificates, and subject documents — it is critical that the plan for management of the site’s clinical trial documentation occurs from the very start of the trial and encompasses the full life cycle of the ISF.

ExL Events’ Investigator Site File Summit will address challenges in designing and ensuring a quality ISF along with creating a process sites, sponsors or CROs can employ to establish compliance and inspection readiness. Over the course of two days, industry leaders will take part in case studies, a panel and engaging sessions developed to ensure conference attendees walk away with a better understanding of how proper document management of the ISF can increase a clinical trial’s quality while monitoring the progress of a trial. In addition to our main program, our pre-conference workshop teaches attendees how to build an ISF management plan that can be used by the sponsor as a template for all sites in a study or by the investigative site for all studies they are conducting. Join us to enrich the quality of your ISF and protect your organization from the risks incomplete, outdated or inaccurate files can cause.

Top Five Reasons to Attend

  • Ensure your ISF is complete and your SOPs are ready in case of an inspection
  • Discuss the switch over to eISF and efficient methods of making the change
  • Analyze strategies to help organize files in a streamlined and comprehensive manner
  • Learn about making strong partnerships with all parties involved to increase the quality of a clinical trial
  • Address best practices for seamless reconciliation with the TMF

Who Should Attend

The Investigator Site Files Summit is designed for professionals from pharmaceutical, biotechnology and medical devices companies with responsibilities in the following areas:

  • Data Management
  • Clinical Operations/Research/Documentation
  • Site Partnerships
  • Investigator Site Files
  • Clinical Compliance
  • Trial Master Files
  • Clinical Data
  • Clinical Quality
  • Trial Documentation
  • Auditing
  • GCP
  • Records Management

This conference is also ideal for professionals from clinical trial sites who are:

  • Study Managers
  • Investigators
  • Study Coordinators
  • Clinical Research Associates