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Regulatory Files Introduction - SCTR - sctrweb2 musc

Regulatory Files Introduction - SCTR - sctrweb2 musc 2025

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The document outlines the structure and importance of Regulatory Files in clinical trials, defining them as essential documents that ensure study reconstruction, data quality evaluation, and regulatory compliance. It emphasizes accurate record-keeping as per federal regulations and provides a flexible format for organizing these files into 16 sections, detailing the types of documents required in each section. The document serves as a guideline for sponsors and investigators to manage trial documentation effectively, ensuring compliance during audits and monitoring.

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What is a regulatory support file?

Regulatory requirements are rules and guidelines businesses must follow to comply with laws and regulations set by governments or regulatory bodies. They vary widely depending on the industry and jurisdiction, covering areas such as financial reporting, data protection, environmental impact, and employment practices.

What is a regulatory file?

These documents are the letters, notices and reports (except IP and tax related filings) and can be submitted to federal, state, alternative government entities or relevant industry bodies. The information contained within the filings covers the financial, operational, technological and legal aspects of your company.

What are regulatory files?

Regulatory documentation is broadly defined as the documents submitted to health authorities in order to support research, development, marketing applications and post-marketing activities.

Which is the regulatory body for clinical research?

Food Drug Administration As per the FDCAct, 21CFR50, and 21CFR312, the FDA is the regulatory authority that regulates clinical investigations of medical products in the United States (US).

What is an example of a regulatory filing?

Regulatory Support Files (RSFs) The information in these files includes detailed information on product performance, stability, quality control and analytical testing methods.

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