Clinical Trials Quality Assurance Management

Aims: 
To provide an introduction to the international regulations and Codes of Practice that govern drug trials on human volunteers, and to develop a broad understanding of the requirements for managing the clinical study and auditing its processes and generated data.

Outline Syllabus: 

• Pathways to drug approvals
• International regulations and protocols for GCP activities, FDA and TGA requirements.
• Project management in the context of new product development and GxP regulations.
• Preparing protocols etc. required for clinical programs
• Data integrity
• Requirements for data collection and records control.
• Auditing requirements for clinical material manufacture.
• Auditing requirements for clinical trials.

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• Describe the functions and pathways involved in product development
• Discuss the purpose of the different clinical trials (Phases I, II and III) and explain how each is conducted.
• List the national and international regulations and protocols for managing GCP activities.
• Discuss the CTN/CTX and IND Approval schemes.
• Understand project management for product development and clinical programs.
• Demonstrate key checkpoints in product development for clinical trials.
• State the key requirements of GCP
• Document what is required for.
• 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.
• Understand the requirements for QA Auditing of Clinical Trials.
• Identify the consequences of non-compliance, misconduct and fraud

(2) Discipline skills

• Prepare patient report reviews.
• Audit clinical trials for adherence to Good Clinical Practice (GCP) regulations
• Prepare audit reports
• Write, implement and update Standard Operating Procedures (SOPs) for data collection, records control, QA reviews and storage/archiving
• Prepare for and manage FDA inspections