Kathy Barnett

Subject Recruitment: Proactive Project Plans and Issues Management

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

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

ICH GCP E6 R3 Updates: Impact on Clinical Data Management

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

FDA Drug Approval Process

Investigator Initiated Trials: Roles and Responsibilities

Inspection Readiness: Understanding BIMO Inspection Req for Sponsors, CROs, Monitors, Investigators

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

Monitoring Oncology Clinical Trials

ICH GCP E6(R3) Updates: Sponsor Quality Management – Risk Mgmt Requirements & Approaches for Comp

Understanding ICH E6 R3 (GCP) Updates: Key Changes from R2

Strategies for Managing Difficult Clinical Research Sites

Strategies for Having Difficult Conversations

Introduction to Data Management

Introduction to Clinical Research

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

FDA Requirements for Electronic Source Data in Clinical Investigations

Developing and Negotiating Research Site Clinical Study Budgets and Contracts

Essential Documentation in Clinical Trials at Research Sites

Implementing Quality Agreements

Good Clinical Practice: A Question & Answer Reference Guide 2024/2025

EU Clinical Trial Regulation (EU-CTR) Requirements

ICH E6 R3 Draft: A Discussion

GCP Renovation (ICH E8 R1 and ICH E6 R3)

Medical Writing Fundamentals: How to Write Regulatory Documents

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

GCP Renovation (ICH E8 R1 and ICH E6 R3)

Essential Documentation in Clinical Trials at Research Sites

Clinical Trial Start-Up: Using a Work Breakdown Structure (WBS) for Effective Planning