Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to describe the procedures for collecting, updating, and maintaining FDA Form 1572 (Statement of Investigator) as part of IND-regulated clinical trials conducted in the United States. It ensures compliance with 21 CFR 312.53 and related regulatory requirements, and facilitates FDA inspections.
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The purpose of this SOP is to establish procedures for registering clinical trials and posting results on ClinicalTrials.gov in compliance with the FDA Amendments Act (FDAAA) Section 801 and Protocol Registration and Results System (PRS). It ensures adherence to regulatory timelines and transparency obligations.
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The purpose of this SOP is to provide standardized procedures for requesting and managing Emergency IND (eIND) submissions to the U.S. Food and Drug Administration (FDA) under 21 CFR 312.310. It ensures that investigational products can be used in urgent, life-threatening situations where no satisfactory alternatives exist, while maintaining compliance with regulatory and ethical standards.
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The purpose of this SOP is to describe specific requirements for safety reporting under 21 CFR 312.32 for IND-regulated clinical trials in the United States. It ensures timely identification, evaluation, and reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) to the FDA in compliance with regulatory timelines.
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The purpose of this SOP is to outline procedures for managing communications and remediation when the U.S. Food and Drug Administration (FDA) imposes a clinical hold or partial hold on an IND-regulated study under 21 CFR 312.42. It ensures timely resolution, protection of subject safety, and compliance with regulatory requirements.
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The purpose of this SOP is to establish a standardized process for preparing for, managing, and responding to FDA Bioresearch Monitoring (BIMO) inspections. These inspections ensure protection of human subjects, data integrity, and compliance with regulatory requirements under FDA oversight.
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The purpose of this SOP is to define procedures for safety reporting and management of device deviations in clinical trials regulated under the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) regulations (21 CFR 812). It ensures that unanticipated adverse device effects (UADEs), device malfunctions, and deviations are reported and managed in compliance with regulatory timelines.
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The purpose of this SOP is to define standardized procedures for coordinating Right-to-Try and Expanded Access (Compassionate Use) programs for investigational products in the United States. It ensures that patients with serious or life-threatening conditions who lack satisfactory alternatives can gain access to investigational therapies in compliance with FDA regulations and ethical standards.
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