We Mapped What Sites Actually Do to Prepare Source Docs – The Results Are Eye-Opening

In late 2025, Tufts CSDD and CRIO conducted a survey among a global community of investigative sites to better understand how sites translate clinical trial protocols and related information into practical tools such as template source documents, study plans, calendars, worksheets and shadow charts for the purposes of ensuring compliant, efficient, and high-quality data collection. In total, 209 sites from a variety of settings responded. This session will review key takeaways from this research and discuss their implications.

This source preparation process is not well understood and the lack of standardized terms describing the process are a source of confusion. At the same time, it is widely acknowledged that the process of source document preparation at investigative sites is inefficient and highly fragmented. This webinar will provide an overview to the comprehensive mapping of systems and workflows that investigative sites use to capture, manage and transmit clinical research data; characterize pain points and challenges that drive delays; and identify opportunities to improve efficiency, speed and quality.

The webinar will begin with a short presentation of the study results. Next, a panel of investigative site representatives will discuss the findings and insights.

Key learning objectives:

Review the typical site workflow for preparing source documents and the critical and rate-limiting documents needed
– Examine the roles and work effort required to prepare source documents and how this varies based on protocol complexity
– Discuss the wide range of paper and electronic systems that sites use to capture relevant study information
– Identify opportunities for sponsors, sites and service providers to enhance the protocol-guided source preparation process and accelerate study activation times