Mini-Sentinel and Clinical Trials Transformation Initiative: Developing approaches to conducting randomized trials using the mini-sentinel distributed database Posted on February 28, 2014February 5, 2025 by Hannah Faulkner Mini-Sentinel and Clinical Trials Transformation Initiative: Developing approaches to conducting randomized trials using the mini-sentinel distributed database
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
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
Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature Posted on May 10, 2013February 11, 2025 by Hannah Faulkner Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature
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
Using Central IRBs for Multicenter Clinical Trials in the United States Posted on January 30, 2013February 11, 2025 by Hannah Faulkner Using Central IRBs for Multicenter Clinical Trials in the United States
Conducting Multi-Center Trials: New Recommendations and Tool for Research Posted on January 30, 2013February 11, 2025 by Hannah Faulkner Conducting Multi-Center Trials: New Recommendations and Tool for Research
Cycle Time Metrics for Multisite Clinical Trials in the United States Posted on January 4, 2013February 20, 2025 by Hannah Faulkner Cycle Time Metrics for Multisite Clinical Trials in the United States
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
Master Protocols Operations Partner Assessment Posted on June 25, 2007February 6, 2025 by Hannah Faulkner Master Protocols: Operations Partner Assessment
