The literature search and screening report for clinical evaluation of medical devices must be compiled covering following parameters. The the accuracy and comprehensiveness of the literature should be guaranteed.
· Device name:
· Model and specification:
· Time range of search:
· Search database:
· Search methods:
· Search terms:
· Logical matching of the search terms:
· Output of search results:
· Description, causes of search deviation and impact on the results:
· Literature screening procedure:
· Literature screening criteria:
· Excluded literature:
· Reasons of exclusion:
· Output of literature screening results:
· Description, causes of screening deviation and impact on the results:
Note: All searched and screened literature needs to be listed in a consistent format. It is suggested to include such information as “author, title, journal name, year of publication, number of volumes (issues), and page number”
· Personnel signature for literature search and screening:
· Date:
Download the template here