Get Serious Adverse Event Sae Form Bericht Ber - Success-studie

This guide provides clear, step-by-step instructions for completing the Serious Adverse Event (SAE) Form Bericht über schwerwiegendes unerwünschtes Ereignis (SUE) online. Ensuring accurate and thorough documentation is crucial, as the form must be submitted to the University of Duesseldorf within 24 hours of the event.

Follow the steps to successfully complete the SAE form online.

1. Press the ‘Get Form’ button to obtain the form and open it in the appropriate online editor.
2. Begin filling out the top section of the form by entering the study or study number and the subject ID. Ensure that you include the year of birth, sex, height, weight, and week of gestation.
3. In the section labeled 'Observed SAE', indicate whether this is an initial report or a follow-up report. Fill in the start date of the SAE, the stop date if applicable, or choose 'ongoing' if the event is not resolved.
4. Provide the date when the SAE became known and classify the reason for the SAE. Choose from options such as death, life-threatening events, abortion, overdose, persistent disability, and others provided on the form.
5. Detail the progress and therapy related to the SAE. It is helpful to attach any relevant medical reports or hospital discharge records to provide further clarity on the situation.
6. Complete the outcome section by indicating whether the individual has recovered, recovered with sequelae, is unknown, not yet recovered, or if death occurred. If death occurred, provide the cause of death.
7. Document the treatment or form of administration by filling out the daily dose, application details, start and stop dates, along with the indication for treatment.
8. Assess the causality by coding the relationship to the medication on a scale from very likely to none. List any main diagnoses, concomitant diseases, and any relevant anamestic characteristics.
9. Fill out any changes in lab parameters connected with the SAE and include the name and telephone number of the physician responsible for the report.
10. Finally, review all information for accuracy. Save any changes made to the form before downloading, printing, or sharing the completed document as needed.

Complete your Serious Adverse Event SAE form online today to ensure timely and accurate reporting.