Quality Management

Primary role

The Quality Management Unit (QMU) at UVRI-IAVI oversees the implementation of all Quality Management activities for the program. The QMU is committed to real time quality control (QC) and systematic Quality Assurance (QA) driving the program’s quality and integrity in research. The QMU performs a number of quality management activities at the different departments to ensure that all processes contributing to the performance of clinical trials and research studies are conducted properly and that key performance quality indicators are closely monitored to ensure continuous quality improvement.

The QMU uses a number of standards and guidelines that include the following;

The International Conference on Harmonization (ICH) Good Clinical Practice.
DAIDS Guidelines for Good Clinical Laboratory Practice Standards (GCLP).
Local and National Independent Ethics Committee guidelines
Uganda National Council of Science & Technology National Guidelines for Research involving Humans as Research Participants available at https://uncst.go.ug/guidelines-and-forms/.
Other regulatory and accredited bodies that monitor research protocols.

All Staff are required to participate in QA / QC activities which includes identifying and resolving deviations that occur in their departments. The QMU ensures adherence and compliance of the program’s research activities to Regulatory and Accrediting bodies with a particular focus on Participant Safety.

Quality Management activities at UVRI-IAVI

Quality Management Plan -QMP

UVRI-IAVI has a Quality Management Plan (QMP) that describes all the program’s quality systems. The plan includes the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. The QMP describes systems for operation, standards, quality practices, resources and processes pertinent to the program activities. It highlights the verifiable systems and procedures for maintaining the highest quality standards during conduct of research by the program.

Clinical Quality Management Plan -CQMP

UVRI-IAVI has a Clinical Quality Management Plan (CQMP) that provides overall guidance for the successful execution of day to day research activities. The CQMP describes all the activities involved in quality control and quality assurance, including assignment of roles and responsibilities, reporting of Quality Control (QC), Quality Assurance (QA) results and resolution of trial conduct issues identified at the UVRI-IAVI clinical research site. The QMU oversees the implementation, monitoring and evaluation of the CQMP.

External Quality Assurance

The UVRI-IAVI laboratory in addition to the routine Quality Control and Quality Assurance activities participates in a number of External Quality Assurance (EQA) surveys with CAP (College of American Pathologists), RCPA (Royal College of Pathologists of Australia) and EQAPOL programs. The Laboratory is regularly audited by the Division of AIDS (DAIDS), Contract Laboratory services (CLS-South Africa) and IAVI. The laboratory is accredited under Good Laboratory Practice by (Qualogy-UK) and all staff undergo GCLP and GCP training

Real time Quality control

The QMU ensures staff at the Statistics and Data Management department perform real time quality control review on data entered by clinic staff to ensure validity and quality of the research data generated. Quality management at the Statistics and Data Management Department is ensured by efficient management of equipment and data base applications, making sure each study has layers of study management staff that include data managers and data entry clerks all with clearly defined roles and training.

Continuous Training

The QMU is tasked with continuous training of UVRI-IAVI staff on all aspects of quality management and also ensuring all study staff are GCP (Good Clinical Practice) and HSP (Human Subjects Protection) certified. GCLP (Good Clinical Laboratory Practice) certification is for all laboratory personnel.

UPTO DATE SOPs

The QMU ensures all required documentaion for the different protocols are up to date as per sponsor and study procedure requirements. The unit oversees the development of all program Standard Operating Procedures (SOPs ). QMU is also responsible for training and ensuring that SOPs are adhered to by the respective staff.

Regular Internal Audits

The QMU conducts regular internal audits for the different departments to ensure studies are being performed as specified in the protocols, Study Specific Procedures manual and also as per donor/sponsor requirements.