Research Outline

Clinical Trial Sites - Regulatory Binders


To prepare an overview of how clinical trial sites handle their regulatory binders in the US, with a breakdown of the percentage that uses electronic binders vs. paper binders. Additionally, to provide information on any correlative data concerning the usage of paper or electronic binders, such as whether a specific geographic location is more likely to utilize paper binders.

Early Findings

  • About 75% of clinical trial sites that have not yet adopted electronic regulatory binders but are planning to do so in 2019.
  • Based on a survey, in 2014, approximately “3 out of every 10 clinical trial sites made the transition to electronic regulatory binder management.” The survey indicated that about 30% [(3/10)%] of the clinical trial sites have adopted electronic regulatory binder management and this share is further growing.
  • In order to increase “staff productivity, speed study start-up, and improve inspection readiness”, many research organizations have started investing in “regulatory document management.”
  • However, only going “paperless” would not solve the purpose of “the core document management issues” such as workflow, change, and signature management.
  • According to a case study on regulatory binder management, when a person who is “responsible for one regulatory binder, and all staff are based at the same location, document management is not complex.”
  • However, in cases where the person who is managing the binder is located at a different place than the investigators and “the files need to be shared across locations, the problem starts to make itself evident.”
  • The use of electronic binders is the solution to the above-mentioned problem.
  • In the electronic shared server environment, “documents are scanned and uploaded to shared server space for easy electronic access, and then manually tracked via spreadsheets.”