Wonder

Research Outline

Prepared for Amanda K. | Delivered September 24, 2019

Clinical Trial Sites - Regulatory Binders

Goals

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.”