Clinical Trial Summary
- Due to recent new legislation, it is now obligatory to post a summary of the clinical trial results for studies performed in the US or EU on online databases for access by the general public. This summary must be submitted within 1 year of completion of the trial.
- The preparation of a Clinical Trial Summary presents the unique challenge of making sure that it is understandable to a layperson. The lay audience is not used to reading scientific information or scanning tables for messages the way people in the industry are. Plain language is essential. Scientific, medical and statistical jargon should not be used, or at least should be explained in plain language in addition to the technical term.
- Trilogy will help you to produce a clear, undaunting and concise Clinical Trial Summary, conveying crucial and complex information in a reader-friendly manner.
- A Clinical Trial Summary may not include any information that allows identification of any subject in a study, as outlined in the EMA policy 0070. While writing a Clinical Study Report (CSR), Trilogy will help your authoring teams to understand potential implications of the information included in a CSR to avoid unnecessarily large efforts for redaction when creating a Clinical Trial Summary.