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St. Luke's University Health Network SOP 102: Trial Master FilesVersion # 2.0-Page 1 of 12PURPOSE: To outline the organization of clinical trials documents such as Regulatory Binders, IND Safety Reports
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To fill out a regulatory binder - national, follow these steps:
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Gather all the required documents and forms that need to be included in the binder.
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Regulatory binder - national is a document that contains all essential regulatory documents needed for a national level compliance.
Any organization operating at a national level and subject to regulatory requirements is required to file a regulatory binder - national.
To fill out regulatory binder - national, one must gather all necessary regulatory documents, organize them properly, and update the binder regularly.
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