Quality Assurance (QA) is a system of oversight required in the conduct of clinical trials. It encompasses Quality Control (QC) processes to ensure that every aspect of a clinical trial is compliant with both sponsor and applicable regulatory requirements.
CHRU has achieved excellent results in audits because of its rigorous QA processes.
The objective of QA is to achieve the highest standard of quality in relation to both data and participant care. This is achieved by ensuring the rights and safety of participants are protected and that data collected is valid, accurate and complete.
The QA team plays a key role in the planning, implementation and evaluation of QA processes at CHRU. This includes:
- Planning for effective protocol implementation
- Reviewing the informed consent process
- Assuring compliance to protocol
- Confirming safety reporting requirements are met and
- Verifying data.
The QA team is responsible for regulatory processes such as clinical trial applications and the maintenance of essential documents as per regulatory guidelines. It also ensures the research sites adhere to:
- CHRU’s Standard Operating Procedures (SOPs)and Policies
- The Division of Acquired Immunodeficiency Syndrome (DAIDS) and sponsor SOPs and Policies
- The ICH Harmonised Tripartite Guideline for Good Clinical Practice
- South African Good Clinical Practice Guidelines and
- Other applicable local ethics and regulatory requirements.
At CHRU, QA is a shared responsibility across clinical trial teams.