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Filling out the Serious Adverse Event Report Form V2.32.pdf is an important step in reporting significant medical events that occur during clinical trials. This guide provides clear, step-by-step instructions to help you accurately complete the form and submit it online.

Follow the steps to accurately complete the form.

1. Click ‘Get Form’ button to obtain the form and open it for editing.
2. Fill in the EudraCT number, participant gender, randomisation number, date of birth, and initials of the participant. Ensure that all information is accurate and complete.
3. Indicate what you are reporting by selecting the appropriate option: Serious Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR), Serious Adverse Reaction (SAR), or Pregnancy.
4. Select the report type — either Initial Report or Follow-up Report. If it is a follow-up report, include the report number as well.
5. Enter the protocol title and version number. This helps to track the specific clinical trial context in which the event occurred.
6. Detail the event or reaction by providing keywords, including symptoms, severity, and treatment received.
7. Identify the chief or principal investigator and the sponsor for the trial.
8. Document the date of onset and time of onset of the adverse event.
9. Select the criteria for defining the event as serious, such as resulting in death, life-threatening circumstances, or hospitalization.
10. Summarize the event including signs, symptoms, diagnosis, treatment, and relevant medical history in the provided space.
11. State if, in the investigator’s opinion, the event was related to the investigational medicinal product.
12. Note any actions taken with the study drug, selecting options from definitely related to not related.
13. Specify if the reaction was unexpected by selecting yes, no, or not applicable.
14. Indicate whether the event abated after stopping the drug and whether it reappeared after reintroduction.
15. Provide information on any concomitant medications and their details, including therapy start and end dates, dosages, and administration routes.
16. If urgent safety measures have been implemented, provide details; otherwise, select no or not applicable.
17. Document the outcome of the SAE, and include dates when the event resolved or if the patient died.
18. Fill in contact information for the person to be contacted for further details, ensuring contact details are current.
19. Obtain required signatures from the person completing the report, along with the principal investigator or chief investigator if applicable.
20. Once the form is complete, save your changes, and you may choose to download, print, or share the form as needed.

Begin your journey in clinical reporting by filling out the Serious Adverse Event Report Form online today.