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Signal Notification / Follow up (FU) information on signalsActive substance _ brand name (therapeutic class) _ adverse reaction (MedDRA term)[??] _ [??] _ [??]General guidanceThis form should be used
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Step 1: Understand the purpose of the validating framework
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What is Validating a Framework for Coding Patient-Reported ... Form?

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Validating a framework is for ensuring that the framework meets established standards and requirements for reliability, accuracy, and compliance in its intended applications.
Individuals or organizations that utilize a specific framework for operations, compliance, or reporting purposes are required to file validating a framework.
To fill out a validating framework, users must provide relevant data about the framework, include compliance checklists, and ensure that all required documentation is accurately completed and submitted.
The purpose of validating a framework is to ensure that it functions as intended, complies with regulations, and meets the needs of stakeholders effectively.
Information that must be reported includes framework specifications, compliance results, validation tests performed, and any deviations or corrective actions taken.
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