Reporting of Trial Monitoring in RCT Protocol Papers

This is data from a systematic review of the reporting of monitoring in protocol papers of randomised controlled trials (RCTs). The systematic review was conducted in April to June 2020 in seven journals that commonly publish clinical trial protocol papers, and in papers published by the BioMed Central publishing group. Data was extracted on each protocol paper published between 1st January and 31st May 2020. This dataset comprises information on the extent of the reporting of monitoring in each protocol paper.

The paper detailing the methodology and findings has been published: Hsieh S-F, Yorke-Edwards V, Murray ML, Diaz-Montana C, Love SB, Sydes MR. Lack of transparent reporting of trial monitoring approaches in randomised controlled trials: A systematic review of contemporary protocol papers. Clinical Trials. 2023;20(2):121-132. doi:10.1177/17407745221143449

The dataset is provided as a .csv file, with columns separated by | [pipe/ vertical bar]. 

Please note regarding the variable 'monitoring_approach': the value 'RBM' corresponds with the "mixed approach" referred to in the published paper.