Features
The most significant advantage of using the tool is time and cost savings in addition to automating the basic results disclosure process and hence making it less error-prone.
This tool transforms clinical data to xml files that can be uploaded to ClinicalTrials.gov, replacing manual data entry.
How it Works
Using user-friendly and descriptive forms, metadata information about the SAS dataset is entered and the corresponding SAS datasets uploaded.
The tool will also allow for the use of the same metadata entered for previous studies, eliminating the need to re-enter metadata for studies sharing the same data structure.
Users can enter Subject Level Datasets (Subject level and Adverse Events) or Summary Data (Adverse Events, Exposure, Baseline Characteristics, and Participant Flow). Sample data and data entry values can be seen here (Subject-Level) and here (Summary-Level). Please contact us if you have questions or need a walk-through.
You will be notified by email once xml files are ready for download -- usually within 1 to 2 business days.