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Contents Page No 1. Introduction 1 2. What is adverse drug reaction? 2 3. Rationale of ADR monitoring 3 4. Recognition of ADR 3 5. What to report 3 6. When to report 3 7. How to report 4 8. Direction
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What is guidelines for adr monitoring?
Guidelines for adr monitoring are a set of instructions and procedures designed to ensure the systematic and effective monitoring of adverse drug reactions (ADR) in order to enhance patient safety and improve drug regulation.
Who is required to file guidelines for adr monitoring?
The pharmaceutical companies and regulatory authorities are required to file guidelines for adr monitoring.
How to fill out guidelines for adr monitoring?
Guidelines for adr monitoring can be filled out by following the prescribed format provided by the regulatory authorities. It typically involves providing information on methods of ADR identification and reporting, criteria for causality assessment, data collection and analysis, and quality assurance procedures.
What is the purpose of guidelines for adr monitoring?
The purpose of guidelines for adr monitoring is to standardize and streamline the process of monitoring, detection, assessment, and reporting of adverse drug reactions. They aim to ensure that adequate measures are in place to identify and manage risks associated with the use of drugs, and to promote patient safety.
What information must be reported on guidelines for adr monitoring?
The guidelines for adr monitoring require the reporting of information such as details of the suspected drug, the adverse event or reaction observed, patient information, severity and outcome of the event, and any relevant concomitant medications or medical conditions.
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