制作精通简明语言摘要的8个技巧

Language SummariesPlain language summaries (PLS) of clinical trial results are required for alltrials conducted within the European Union (EU). Kimberly Green, Founder 1. Be aware of timelines2. Plan your outputsAll regulatory documents have timelines,but the recent addition of the PLSrequirement means those timelines mustYou may want toincorporate data outputsnot already included in a 3.Have templates ready, but maintain flexibilityA template lends consistency to format and helps ensure all requiredelements are represented. But the template should be flexible to ensure eachPLS is presented in a way that will be intuitive and meaningful for the reader.4.Clarify what constitutes commercially confidentialinformation (CCI) 6.Consider judicioususe of graphics and designIn PLS, words need to be chosencarefully. Language that might beincluded in a clinical study report (CSR)could be perceived as promotional inIf possible, have someone involved in theprocess with expertise in graphics and 7.Be careful when translatingto other languagesA correctly, and succinctly in the translation. 8.Consider having your PLS reviewedby a patient panel when feasibleIf you have the time and budget, a review by an independent panel canprovide invaluable input on whether the PLS is easily understandableto the public, as well as what language is respectful to the intendedaudience and patient population. This type of review is especiallyhelpful for organizations just getting started in PLS authoring. Get expert support from theTrialScope Disclosure Servicesteam or host your summaries usingTrial Summaries. To learn about our full range of solutions, visitCiteline.com.