The Clinical Trials Unit (CTU) at the UVRI Clinical Research Program Initiative is a dedicated clinical research unit responsible for the conduct, management, and oversight of high-quality clinical trials in accordance with approved protocols, Good Clinical Practice (GCP), regulatory requirements, and international ethical standards.

The CTU supports the full clinical trial lifecycle, from study start-up and regulatory and ethical approvals through participant recruitment, trial implementation, clinical and safety management, data and documentation oversight, monitoring, annual continuing review/renewal, and study close-out. The Unit works closely with study sponsors, investigators, regulatory authorities, ethics committees, laboratories, and community stakeholders to ensure that clinical trials are conducted safely, efficiently, and to the highest scientific and ethical standards.

Facilities

The CTU has dedicated facilities which include:

Clinical Rooms

The clinical rooms provide a private and confidential environment where participants undergo study-related clinical assessments and procedures

Pharmacy

The CTU has a dedicated study pharmacy responsible for the secure management of investigational medicinal products and other study-related medications.

The pharmacy supports the receipt, storage, temperature monitoring, accountability, dispensing, reconciliation, and appropriate handling of investigational products in accordance with study protocols, pharmacy procedures, GCP, and regulatory requirements.

Study Offices

The study offices provide workspace for the clinical research and study teams involved in the day-to-day management of clinical trials.

Participant Waiting Area

The participant waiting area provides a comfortable and welcoming space for participants before and between study procedures. Participants are received and guided through the different stages of their study visit, including registration, clinical assessment, laboratory procedures, pharmacy activities, counselling, and other protocol-required procedures.

The waiting area also provides an opportunity for participants to receive general study information and support while ensuring privacy, dignity, and respectful treatment throughout their visit.

Responsibilities of the Clinical Trials Unit

• Clinical trial implementation and oversight across Phase I–III studies and other clinical research programmes.
• Regulatory and ethical submissions, including initial applications, protocol amendments, continuing reviews/annual renewals, safety reports, and other regulatory requirements.
• Participant safety and clinical management, including clinical assessments, management of adverse events and medical conditions, safety reporting, referrals, and appropriate follow-up.
• Participant recruitment, retention, and follow-up, with emphasis on informed consent, participant rights, confidentiality, and participant-centred care.
• Protocol compliance and quality management, including identification, documentation, investigation, and resolution of protocol deviations, queries, and quality issues.
• Study documentation and data quality, ensuring that clinical information is accurate, complete, timely, and appropriately documented.
• Pharmacy and investigational product management, including receipt, storage, accountability, dispensing, reconciliation, and appropriate handling of study products.
• Monitoring, audits, inspections, and sponsor oversight, including preparation for monitoring visits, quality assurance reviews, regulatory inspections, and study audits.
• Study start-up and close-out, including site preparation, staff training, essential documentation, trial-specific systems, and completion of close-out requirements.

Team: The CTU is constituted by the following: Medical Officers, Clinical Officers,      Clinical Research Nurses, Pharmacists, Study Coordinators/Regulatory Officers.

Commitment: The CTU’s work is a commitment to participant safety, scientific integrity, regulatory compliance, and high-quality clinical research. The Unit strives to ensure that every participant is treated with dignity, respect, and confidentiality and that research activities are conducted ethically, transparently, and in accordance with applicable national and international standards.