This is an independent unit established under the directorate to help researchers ensure integrity of their research projects. The main function of the unit is to ensure all research conducted by our IHI have clearly defined standards to be followed during the entire period of the study (from protocol development, data collection & analysis to publications) and that the research complies with these standards. We advise clients on how to verify the integrity of their scientific data, ensure adherence to protocols and international regulatory guidelines through training, research audits and regular monitoring activities. We also assist clients uphold project participants rights and welfare. The unit is has qualified personnel, experienced in conducting quality assurance programs for a variety of research fields. The staff are conversant with local, national and international regulations, standards and guidelines to ensure high quality scientific data.
Services offered by the unit include:
Training: Our training packages are aimed at enabling project personnel to be aware of Quality issues in every day research activities and have the knowledge and skills to tackle them in accordance to national and international standards. It is also aimed at enabling personnel to establish/design own quality control systems to monitor quality of their projects. The training package includes: a) basic knowledge of Quality in Research projects, Quality Management System management set up and Maintenance package, b) Project Management Skills, c) Good Clinical Practice (GCP), d) Good Clinical Laboratory Practice and e) Good Research Practice
Quality Assurance Audits: Comprehensive quality audit programs are conducted on projects as part of a full-service or a single contact contract. Our thorough assessment and insightful, objective recommendations will help researcher develop the most effective action plan to correct and/or prevent raised issues. Among the quality audits conducted:
- Site audits (routine, directed, specialized and pre-inspection audits to help site qualification or for regulatory agency reviews)
- Database audits and study report reviews
- Study document reviews
- System audits, in which we assess a client’s standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed
- Laboratory audits (routine audits to ensure compliance Good Laboratory Practice (GLP) and other set standards).
- Accreditation assistance (directed and specialized audits designed to assist in the laboratory accreditation process)
Monitoring: Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory/ethical compliance
- Resolve data queries
- Conduct interim analyses as requested by clients