GXP Solutions | Good Clinical Practice (GCP) Training

Good Clinical Practice (GCP) Training

This GCP training course provides essential information about ICH E6 (R2). This training is developed as an interpretation of the ICH E6 Good Clinical Practice consolidated guidelines. It is an introduction to GCP and can serve as a refresher course. It is suitable for everyone involved in clinical research.

Note

Course content can be tailored to your business needs.

All courses are live group or webinar training events only.

Course 1 - Good Clinical Practice (e.g., ICH E6 (R2) Regulations

Good Clinical Practice (e.g., ICH E6 (R2) Regulations

Introduction
Ethics Committees
Investigators
Informed Consent
Sponsors
Monitors
Clinical Trial Protocol
Recording and Reporting
Essential Documents

Course 2 - Good Clinical Practice (GCP) Auditing Course

Good Clinical Practice (GCP) Auditing Course

Module 1: Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
Module 2: Auditing as a Profession and Compliance Tool
Module 3: The Types of Clinical Research Audits and Preparation
Module 4: Quality Systems for Auditing
Module 5: Risk-Based Auditing and Developing Risk-Based Auditing Plans
Module 6: The Auditing Process: Clinical Investigator
Module 7: The Auditing Process: Institutional Review Board/Ethics Committee
Module 8: The Auditing Process: Sponsor/CRO
Module 9: Gathering and Disseminating Information: Verbal and Written Communication
Module 10: Regulatory Classification and Communication: Recent Inspection Findings