Aims and Objectives
This subject aims to expand upon the material taught in HES6406 to cover GMP aspects of clinical trials. This subject introduces auditing requirements for clinical trials.
On completion of this subject students will be able to:
- Understand and interpret international regulations and protocols for GCP activities, State FDA and TGA requirements for GC
- State principles of New Product Development and GxP Regulations
- State requirements for GCP protocols required for clinical programs including data collection and records control.
- Audit Clinical Protocols and Trials
Content
This subject consists of 5 modules or topics:
#1 Introduction to GCP
This module introduces international regulations and protocols for GCP activities, FDA and TGA requirements.
- Have an appreciation for international regulations and protocols for GCP activities.
- Briefly explain Phases I, II, III and IV.
- Have an appreciation for FDA and TGA requirements.
#2 New Product Development and GxP Regulations
This module gives an overview of project management in the context of new product development and GxP regulations.
- Discuss the CTN/CTX and IND Approval schemes.
- Have an overview of project management for product development and clinical programs.
- Demonstrate key checkpoints in product development for clinical trials.
#3 Clinical Programs - Protocols, Recruitment, Initiation, Assessment & Management
This module details protocols etc. required for clinical programs including data collection and records control.
- State the key requirements of GCP
- Document what is required for:
- Data collection
- Records control
- QA reviews and
- Storage/archiving.
#4 Product Manufacture and Distribution
This module introduces auditing requirements for clinical material manufacture:
- List the key GMP requirements for the manufacture of materials for clinical trials.
- Define the terms "blinding" and "randomisation" as they relate to clinical trials.
- List the key GMP requirements for the labelling and packaging of materials for clinical trials.
- Identify potential sources of errors and mix ups in the distribution of material for clinical trials and list strategies to prevent their occurrence.
#5 Auditing Clinical Protocols and Trials
This module introduces auditing requirements for clinical trials.
- Understand the requirements for QA Auditing of Clinical Trials.
- Prepare patient report reviews.
- Have exposure to investigations and data reviews.
