The specification is designed to capture the contents of a stability report to be submitted to a national regulatory agency. The primary point of reference is current stability reporting within the United States. The scope of a single transaction/message in this specification has been restricted to studies with a single set of storage conditions. Studies that require multiple storage conditions and or orientations (e.g., accelerated, room temperature, inverted, upright, etc.), will be handled through the submission of multiple linked reports, with each report covering a single storage condition and orientation.