In collaboration with the UCSF Data Coordinating Center (USDHHS/NIH/NIDCR U54DE019285, subproject 9001), we have created a set of computer data analysis programs (SAS macros) and corresponding documentation which can produce tables in the format of the ClinicalTrials.gov sample tables for minimal Basic Results reporting.

These SAS macros will assist investigators with FDAAA results reporting requirements and include:

• Participant Flow Summary Form
• Baseline Age, Gender, Race, Ethnicity, and Region Forms (combined)
• Outcome Measure Summary Form
• Serious Adverse Event Summary Form
• Software Tools for Basic Results Reporting
• Other (Not Including Serious) Adverse Event Form

SAS datasets are required in order to record relevant information and indicate variable names to produce the tables formatted to facilitate FDAAA reporting requirements. The race and ethnicity reporting use NIH/OMB categories; they can be customized by users as well. The adverse events and serious adverse events require users to categorize the events by term and organ system.