Research integrity assessment for randomized controlled trials in systematic reviews

A tool to assess the integrity of research reported in randomized controlled trials (RCTs) of investigational medicinal products. The assessment uses signalling questions to identify problematic RCTs and is used when studies are being considered for inclusion into systematic reviews.

RCTs with red flags regarding research integrity should be excluded and RCTs with open questions should be held in awaiting classification until clarified.

The results of the research integrity assessment should be transparently reported and published together with the systematic review.