Get the free Individual Case Safety Report Form

EVPM ICSR(s)EudraVigilanceIndividual Case Safety Report FormGeneral Information EudraVigilance Local Report NumberEUEC10008490019Sender TypeHealth professionalSender\'s OrganisationMODERNA BIOTECH

How to fill out individual case safety report

How to fill out individual case safety report

1. Gather all relevant information about the case, including patient demographics, medical history, and details of the adverse event.
2. Document the onset date of the adverse event and any relevant medical interventions.
3. Fill out the individual case safety report form accurately and completely.
4. Include any relevant laboratory results or imaging studies related to the adverse event.
5. Submit the completed individual case safety report to the appropriate regulatory authority or pharmacovigilance program.

Who needs individual case safety report?

1. Healthcare professionals
2. Pharmacovigilance specialists
3. Drug manufacturers
4. Regulatory authorities

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What is individual case safety report?

An individual case safety report (ICSR) is a document that contains detailed information about adverse events or side effects experienced by patients following the use of a specific medication or medical product.

Who is required to file individual case safety report?

Manufacturers, healthcare professionals, and sometimes patients are required to file ICSRs to regulatory authorities when they become aware of adverse events related to a drug or medical product.

How to fill out individual case safety report?

To fill out an ICSR, one must provide specific details such as patient information, description of the adverse event, drug details, and any concomitant medications. Each regulatory authority may have specific forms and guidelines.

What is the purpose of individual case safety report?

The purpose of an ICSR is to collect and analyze adverse event data to ensure drug safety, inform regulatory actions, and improve public health by identifying potential safety concerns.

What information must be reported on individual case safety report?

The report must include patient demographics, drug details (name, dosage, route of administration), the nature of the adverse event, and any relevant medical history or concurrent medications.