le 7 octobre 2020

How Innovative Technology Supports Remote Source Document Review

The COVID-19 pandemic has created challenges for many standard practices in clinical trials, particularly in-person monitoring. Some sites have been closed to Clinical Research Associates (CRAs) who typically make routine visits to monitor site activity, regulatory compliance and site data collection.

Fortunately, technology developed by Protocol First and in use for several years by Syneos Health®, provides a proven solution that enables CRAs to perform their tasks remotely. The Protocol First Source Upload (P1 Source Upload) tool is well suited to meet the current challenges forced upon clinical trials by the COVID-19 pandemic.

We explain here how it works, and highlight its successful use in an umbrella trial (a master protocol in which all patients share a common tumor type) for patients with acute myeloid leukemia (AML), the Leukemia & Lymphoma Society (LLS) Beat AML® Master Clinical Trial, which began in 2016.


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