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IRM PROCEDURAL UPDATE DATE: 10/21/2024 NUMBER: ts2110241054 SUBJECT: Updated Supplemental Form 94xx Handling Instructions AFFECTED IRM(s)/SUBSECTION(s): 21.7.2.7.6.6 CHANGE(s): IRM 21.7.2.7.6.6(7)
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Who needs revised case control instructions?

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Healthcare professionals involved in case management.
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Any party responsible for data collection and analysis in health-related investigations.
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Revised case control instructions are updated guidelines or procedures that outline how to manage and report case control studies or analyses in a specific context, ensuring compliance with regulatory standards.
Individuals or organizations conducting case control studies, including researchers, scientists, or institutions that are mandated to report findings in compliance with regulatory authorities, are required to file revised case control instructions.
To fill out revised case control instructions, follow the provided template carefully, include all required information accurately, ensure that all data is relevant and complete, and double-check for errors before submission.
The purpose of revised case control instructions is to provide clear, systematic guidance for reporting case control studies, ensuring consistency, accuracy, and adherence to regulatory requirements while facilitating better understanding of the findings.
The information that must be reported includes study design details, case and control group definitions, data collection methods, statistical analysis plans, and any relevant findings or conclusions.
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