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Clinical Trials Transformation Initiative

Related: Safety Reporting

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Posted on May 1, 2014February 11, 2025 by Hannah Faulkner

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Posted on January 30, 2014February 11, 2025 by Hannah Faulkner

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Posted on November 7, 2013February 11, 2025 by Hannah Faulkner

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Participants’ Perspectives on Safety Monitoring in Clinical Trials

Posted on May 3, 2013February 11, 2025 by Hannah Faulkner

Participants’ Perspectives on Safety Monitoring in Clinical Trials

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety

Posted on May 20, 2011February 11, 2025 by Hannah Faulkner

Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety

Posted in Press Releases, Related: Safety Reporting, SAE Reporting, Safety, Study Operations, Uncategorized

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