The Medical Devices Introductory Course 2020

Example of a Literature Search Report Contents

• Device name • Period(s) covered by search • Dates / Name(s) of persons undertaking search • Literature sources used to identify data • Search terms and Boolean Logic • Selection criteria for choosing articles • Unedited search algorithm (e.g. screenshots of the searches or exact search strings) • Search outputs and overview of screening process (including reasons for exclusion) • Summary of results (e.g. Flow chart showing suitability for inclusion) • Relevant articles are then appraised and incorporated into the CER

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Example of a literature flow chart (1) Records identified through database searches (n= )

Records after removal of duplicates (n= )

Records excluded based on abstracts (n= )

Identification Appraisal/Screening Inclusion

Records screened/assessed for eligibility (n= )

Records appraised/assessed for eligibility (n= )

Records excluded based on fulltext (n= )

Studies included in clinical evaluation report (n= )

The Organisation for Professionals in Regulatory Affairs