Investigator Site File (ISF Assessment)

There has been a request from our members to develop a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations. This would be similar to what we already offer (for free) to sites around the globe to evaluate their EHR systems or other systems that originate data that may become part of a clinical trial (this questionnaire is called “eSRA” for “e-Source Readiness Assessment” and can be found on our website at eSRA (eclinicalforum.org)).  The team is under the guidance of the eCF REG team, which produces the “eCF Requirements” that the eSRA and ISF assessments are based on.  A Pilot of the eISF Assessment Questionnaire and Handbook was run in 2023. We anticipate a public/free release of this product in early 2024.  For more information or to become involved in this team, members should send an email to ISFA@eclinicalforum.org.