Quality Control and Regulatory Unit

The Quality Control and Regulatory Unit ensures ethical compliance, participant safety, and data integrity across all clinical research phases, upholding rigorous standards for quality and regulatory adherence at Makerere university Lung Institute.

KEY FUNCTIONS

1. Regulatory Compliance Oversight

   – Ensure all required regulatory approvals are obtained and documented before studies begin.

   – Submit and implement protocol amendments only after approval and staff training.

   -Submit annual applications for continuation of trials/studies in a timely manner.

2. Quality Assurance and Internal Monitoring

   – Conduct internal monitoring to verify data accuracy and protocol adherence.

   – Address protocol deviations with corrective actions to prevent recurrence.

3. Training and Staff Qualification

   – Confirm that all study staff complete required training and are properly delegated.

   – Provide protocol and SOP training to ensure staff readiness.

4. Data Integrity and Document Control

   – Implement a data assurance plan and quality control processes for accurate data handling.

   – Maintain well-organized essential documents in the Investigator Site File (ISF).

5. Adverse Event Reporting and Participant Safety

   – Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).

   – Protect participant rights and safety through proper consent and monitoring.