Get Serious Adverse Event Follow Up Form

Filling out the Serious Adverse Event Follow Up Form accurately is crucial for ensuring patient safety and regulatory compliance. This guide offers step-by-step instructions for completing the form online, tailored to support users with varying levels of experience.

Follow the steps to complete the form effectively

1. Press the ‘Get Form’ button to access the form and open it in the editor.
2. Provide further details of the Serious Adverse Event (SAE) or suspected unexpected serious adverse reaction (SUSAR). Include information such as the body site, reported signs and symptoms, and diagnosis if known. Indicate the maximum intensity of the event (mild, moderate, severe) and specify the end date, end time, or duration.
3. Describe the outcome of the event. Indicate whether it is resolved, ongoing, or resulted in death. If applicable, provide details regarding the patient’s withdrawal from the study.
4. Document any additional actions taken since the initial report and provide relevant further information, such as medical or family history and test results.
5. Sign the form by printing your name and providing your signature. Indicate the date of submission.
6. For studies involving investigational medicinal products (IMPs), include the details of concomitant medications. List the brand name, indication, route, form, total dose per 24 hours, regimen, start and stop dates, or duration.
7. Complete the study IMP section, specifying brand name, indication, batch, route, form, and total dose per 24 hours. If concerning a blinded study, indicate whether the randomization code was broken and provide details if necessary.
8. Review the entire form to ensure all required fields are accurately filled in. After completing the form, save changes, download, print, or share it as needed.

Complete your Serious Adverse Event Follow Up Form online today to ensure prompt and accurate reporting.