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This document is used for reporting adverse events related to clinical studies at Indiana University Health Ball Memorial Hospital, including event classification, causality assessment, and actions

How to fill out adverse event reporting form

How to fill out Adverse Event Reporting Form

1. Begin by gathering all relevant information about the adverse event.
2. Fill out the patient's details including name, age, and contact information.
3. Provide details about the healthcare provider or institution reporting the event.
4. Describe the adverse event clearly, including symptoms, severity, and duration.
5. Specify the date and time the adverse event occurred.
6. List any medications or treatments being administered at the time of the event.
7. Include any previous medical history that may be relevant.
8. Sign and date the form to certify the information is accurate.
9. Submit the form as directed, either electronically or by mail.

Who needs Adverse Event Reporting Form?

1. Healthcare providers, including doctors and nurses.
2. Clinical trial sponsors and investigators.
3. Pharmaceutical companies.
4. Regulatory agencies responsible for drug safety.
5. Patients or their representatives reporting adverse events.

People Also Ask about

What is the difference between FDA Form 3500 and 3500A?

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

What is the difference between FDA 3500 and 3500A?

FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory reporting. * The majority of the indirect, mandatory reports were not received by Agency on a paper version of form 3500A [by mail or fax] but via an electronic submission route.

How many days must a FDA mandatory reporting form 3500A be submitted to the FDA?

Initial reporting: Any unanticipated adverse event suspected to be caused/associated with a device must be reported to the FDA and the reviewing IRB within 10 working days of the event.

What is a 3500A form?

Purpose. Use form FTB 3500A to obtain California tax-exempt status, if the organization has a federal determination letter granting exemption under IRC Sections 501(c)(3), 501(c)(4), 501(c)(5), 501(c)(6), 501(c)(7), or 501(c)(19).

What is the ADR reporting form?

World Health Organization (WHO) defined ADR as “A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.”[ 1]

For pdfFiller’s FAQs

What is Adverse Event Reporting Form?

The Adverse Event Reporting Form is a standardized document used to report any unintended or harmful medical occurrences related to the use of a drug, medical device, or other healthcare-related intervention.

Who is required to file Adverse Event Reporting Form?

Healthcare professionals, pharmaceutical companies, and patients who experience adverse events are typically required to file the Adverse Event Reporting Form.

How to fill out Adverse Event Reporting Form?

To fill out the Adverse Event Reporting Form, one must provide details such as the patient's information, description of the adverse event, date of occurrence, and any relevant medical history or treatment administered.

What is the purpose of Adverse Event Reporting Form?

The purpose of the Adverse Event Reporting Form is to collect data on adverse events to ensure patient safety, evaluate the risks associated with therapies, and improve public health outcomes.

What information must be reported on Adverse Event Reporting Form?

The information that must be reported includes patient demographics, details of the adverse event, the suspected product or treatment involved, and any relevant medical history or concurrent medications.