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Report version Dates Report source / typeInitialFollowup #Date initially received(dd/mm/by)1:Date new information (FM) received (dd/mm/by):Country of Event:SpontaneousRegulatoryConsumerLiteratureNonInterventional
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How to fill out case safety report form

01
To fill out a case safety report form, follow these steps:
02
Begin by entering the date and time of the incident in the designated sections.
03
Provide a detailed description of the incident, including what happened, where it occurred, and any contributing factors.
04
Indicate any injuries or damages caused by the incident.
05
Include information about any witnesses or individuals involved in the incident.
06
Attach any relevant supporting documents, such as photographs or medical reports.
07
Complete the form by signing and dating it.
08
Submit the filled-out form to the appropriate authority or department responsible for case safety reports.

Who needs case safety report form?

01
Case safety report forms are typically required by organizations or agencies that aim to maintain safety standards and investigate incidents. This can include workplaces, healthcare facilities, educational institutions, transportation companies, and law enforcement agencies.

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A case safety report form is a document used to report adverse events, side effects, or safety concerns related to a medical product or prescription medication.
Healthcare professionals, pharmaceutical companies, and any other individuals or organizations involved in the monitoring of drug safety are typically required to file case safety report forms.
To fill out a case safety report form, gather all relevant details about the adverse event, including patient demographics, product information, event description, and any other necessary medical history before entering this information in the designated fields on the form.
The purpose of the case safety report form is to systematically collect and share information about safety issues related to medical products, which helps regulatory authorities monitor and evaluate their safety profile.
The information that must be reported includes the patient's age, gender, medical history, details of the adverse event, the product name, dosage, and any other treatments administered.
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