Archive: FDA Drug Approval Process

Archive: FDA Medical Device Approval Process

Archive: FDA Requirements for Electronic Source Data in Clinical Investigations

Archive: FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

Archive: FDA's Updated Informed Consent Guidance: What's New?

Archive: Final AE Regulatory Guidance

Archive: Final FDA Guidance: How to Complete the Form FDA 1572

Archive: Final ICH GCP E6 R2: Changes Impacting Clinical Investigators, Sites, and IND Holders (Sponsors-Investigators and Institutions)

Archive: Five Key Strategic Steps for Developing Global SOPs

Archive: Fraud in Clinical Research: An Overview

Archive: GCP Renovation (ICH E8 R1 and ICH E6 R3)

Archive: GCP Training for Investigators

Archive: Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

Archive: Good Clinical Practice: Practical Application and Implementation

Archive: HIPAA Team Training: Fundamental Training Specifically for Clinical Research Settings

Archive: ICH E6 (R3) Draft: A Discussion

Archive: ICH E6(R3) and ICH E8(R1) Updates: Impact on Sponsors

Archive: ICH E8 (R1): Changes Impacting Sponsors/CROs

Archive: ICH E8 (R1): Designing Quality into Clinical Studies

Archive: ICH GCP E6 R2 and R3 Updates: Implementing Risk Management Approaches for Compliance

Archive: ICH GCP E6(R3) Updates: Impact on Clinical Data Management

Archive: ICH GCP E6(R3) Updates: Key Changes Impacting Sponsors and CROs

Archive: ICH GCP E6(R3) Updates: Overview of Changes Impacting Sponsors, CROs, and Clinical Investigators/Sites