Author: Anna Lok, MD, and Julie Lumeng, MD on July 22, 2025 
Clinical trials are the gold standard for evaluating the benefits and risks of interventions in clinical research. A high-quality clinical trial protocol document can facilitate faster and more efficient discovery, simplify the execution of complex study designs, make protocols easier for less experienced clinical research staff to accurately implement, and decrease the likelihood of avoidable protocol amendments and deviations.
There is no accepted method to evaluate the quality of clinical trial protocol documents holistically. The Protocol Quality Rating Tool (PQRT) has been developed to assess comprehensiveness, organization, and consistency of clinical trial protocol documents. It has been tested on a library of sample protocols and demonstrated its adaptability to an extensive range of trials. You can read our paper on the PQRT here.
The PQRT can be used by researchers to evaluate their protocols, by institutions to assess the impact of training programs on protocol quality, and by individuals for self-assessment to affect learning and inform the need for additional training. The PQRT and its usage instructions are freely available. We welcome researchers to use and improve on the tool!
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