CIDRZ Research & Regulatory Support
Based on Zambia National Health Research priority agenda, CIDRZ aims to identify locally-relevant, culturally-acceptable, resource-appropriate, evidence-based interventions that will influence evidence-based policy formulation. Therefore, in pursuit of evidence based policy decisions informed by available systemic evidence that produce better outcomes, CIDRZ conducts research studies ranging from clinical trials, surveys, behavioral and implementation science studies. Most studies are conducted within public clinical care facilities in Lusaka. All are endorsed by the MOH and undergo continuing ethical review.
To support this research, the Research Ops dept has implemented a robust administrative system to manage more than 30 on-going research studies at a time. These systems ensure that services are provided in an efficient and transparent manner.
Research Operations Dept- Headed by Head of Research operations.
- Two QA-QC Coordinators
- One CIDRZ Translator
- One Archivist
CIDRZ recognizes the fact that all research involving human participants must be conducted in accordance with the ethical principles governed by International Conference on Harmonization (ICH) and other current guidelines such as the Code of Federal Regulation 45 part 46 (CFR), Council for International Organizations of Medical Sciences (CIOMS), and national laws and regulations. In this regard, the Centre for Infectious Disease Research in Zambia (CIDRZ) has a designated Research Operations department under the leadership of Hope Chinganya responsible for meeting each applicable regulatory requirement for both in country and internationally. This department for more than ten years has demonstrated the capability to assure compliance with all international and national regulatory bodies.
CIDRZ will ensure that all trial applications or notification to any ethical bodies and relevant authorities, amendments to the trial protocol, reporting of all adverse events, and notifications are thoroughly reviewed by this department before submission to ensure that all submissions are within the confines of the applicable laws and regulations. The department maintains a current knowledge base of existing or emerging regulations and guidance documents from all regulatory authorities and ethical bodies. Further, the department is current with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guidelines and the US Code of Federal Regulations regarding Human Subject Protection (CFR Title 45 Part 46). The department further ensures that all parties involved in the clinical trial fully comply with the existing national and international regulations and requirements.
