ICH-FDA Good Clinical Practice – Managing Clinical Trials

Description :

This course provides an overview of the critical elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to Sponsor Responsibilities and Quality Management of the clinical trial.

This webinar has been specifically designed to help attendees manage a GCP compliant clinical trial. It will provide a background and understanding of the role played by the Sponsor, IRB, Investigators, and the Regulatory Authorities. Attendees will be taken through the key stages of the clinical trial processes.

Areas Covered in the Session :

The Principles of ICH GCP

Informed Consent

HIPPA Compliance

Ethics & IRB Responsibilities

Investigator Responsibilities

Sponsor Responsibilites

Quality Management

CRO Selection

Trial Design/Protocol

Trial Management

Investigator Selection

Data Handling/Recordkeeping

Essential Documents

Monitoring

Auditing/ Regulatory Authority Inspections

FDA Warning Letters

Who Will Benefit:

Clinical Quality Assurance Professionals

Clinical Research Associates

Project Managers

Investigators

Study Coordinators

GCP-Focused Regulatory Affairs Professionals