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Get Adverse Event Reporting Form Eng - Bgedeonb Brichterb - Gedeon-richter
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How to fill out the Adverse Event Reporting Form Eng - BGedeonb BRichterb - Gedeon-richter online
Filling out the Adverse Event Reporting Form is an important step in ensuring patient safety and effective pharmacovigilance. This guide provides a comprehensive walkthrough to help users complete the form with confidence and accuracy.
Follow the steps to successfully complete the form.
- Click ‘Get Form’ button to obtain the form and open it in your preferred editor.
- Begin by entering the patient's initials in the designated field, followed by their date of birth (day, month, year) or age.
- Select the patient's gender from the options provided: Male or Female.
- Fill in the onset date of the adverse event, specifying the day, month, and year.
- Indicate the cessation date of the event, again with day, month, and year format.
- Describe the adverse event in detail in the specified section.
- Select the seriousness criteria of the event from the options available, such as death, life-threatening, hospitalization, etc.
- Answer whether the adverse reaction improved after discontinuing the drug, selecting yes, no, or not applicable.
- Indicate whether the adverse reaction reappeared after the drug was readministered with applicable choices.
- Choose an outcome for the side effect from the provided selections, giving details if 'other' is chosen.
- Provide details of the suspect drug(s), including the generic name.
- Specify the route of administration, such as oral, intramuscular, or intravenous.
- Indicate the indications for use of the suspect drug(s).
- Enter the daily dose of the drug(s).
- Document the therapy dates or duration with start and end dates.
- Confirm if the drug(s) were discontinued and provide the date if applicable.
- List any concomitant drugs and their administration dates in the relevant fields.
- Provide any other relevant medical history in the designated section.
- Complete the reporter details by entering the reporter's name, type (e.g., doctor, pharmacist), workplace address, and phone number.
- Enter the reporting date in the specified format.
- After reviewing the information for accuracy, save changes, and proceed to download, print or share the completed form as needed.
Take the necessary step to protect patients by completing the Adverse Event Reporting Form online today.
4.2 Minimum Criteria for Reporting However, for the purpose of regulatory reporting, the minimum data elements for an ADR case are: an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product.
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