Get Adverse Events Module

The Adverse Events Module is a critical component designed to summarize data about serious and other adverse events collected during a clinical study. This guide provides clear, step-by-step instructions for users to effectively fill out the module online, ensuring proper documentation of these events.

Follow the steps to successfully complete the Adverse Events Module.

1. Press the ‘Get Form’ button to access the Adverse Events Module and open it in the editing interface.
2. Begin by filling out the overall adverse event information. Include the time frame for data collection and an additional description of the adverse event data.
3. Complete the Serious Adverse Event (SAE) Table. Include the arm or group title and description, total number affected by any SAE, and total number at risk for SAE.
4. Fill out the adverse event term section. Indicate the adverse event term and provide an additional description. Select the organ system from the provided list and input the number of affected participants and the number of SAE events.
5. Proceed to the Other Adverse Events Table. Similar to the SAE table, report other adverse events that exceed a frequency threshold of 5 percent.
6. Review your entries for consistency and accuracy, ensuring that abbreviations are expanded and arm/group descriptions provide necessary information.
7. Once all information has been entered, users can save changes, download, print, or share the form to ensure the data is documented correctly.

Complete the Adverse Events Module online to ensure accurate and comprehensive reporting.