OBJECTIVES: The same standards should apply for measuring patient reported outcomes (PRO) as for any clinical measure used for an effectiveness claim. Yet, discrepancies between the number of submissions and the number of PRO claims granted illustrate how difficult it is to demonstrate the "substantial evidence" required by authorities. Reporting PRO data separately from the clinical data makes reviewing PRO claims difficult. However, International Conference Harmonization (ICH) guidelines provide no standard location for PRO measurement information. Better integration of PRO data in clinical reports and standardized documentation of PRO measures would improve the reviewing process and enhance the likelihood of securing claims. We will present the value of implementing a standardized approach to documenting PRO measures in regulatory submission reports. METHODS: Our recommendations are based on ICH guidelines and the ERIQA and PRO Harmonization group recommendations. While current ICH report guidelines provide no headings for documenting background information on PRO measures, appropriate headings can be added to report PRO methods and findings as part of the primary clinical trial report without modifying the ICH numbering system. However, the questionnaire development and validation relevant to the condition and treatment considered are better located in supporting appendices as are reviews of literature documenting the use and interpretation of data collected with it. RESULTS: These appendices should include evidence of the clinical significance of differences to help reviewers familiarize themselves with the instrument. CONCLUSION: Better integration of PRO in clinical study report guidelines and the development of a specific system for standardized documentation of PRO measures will enhance transparency and acceptance of PRO data, and thereby increase the acceptance by decision-makers of effectiveness claims based on PRO.