The following is a brief outline of the courses currently being offered by KAVI-ICR.
1.1 Good Clinical Practice (GCP)
This training is designed for health care professionals interested in clinical research. The objective of the course is to equip the trainees with the necessary skills and knowledge to enable them to carry out clinical research to the required international standards.
The scope of GCP training covers the following: Introduction to GCP, Ethical Basis of GCP, Ethics Committees/Institutional Review Boards, Sponsor Responsibilities, Investigator Responsibilities, The Protocol/Phases of Clinical Trials, Informed Consent Process, Essential Documents, Safety Assessment and Reporting, Data Management, Monitoring Clinical Trials, Standard Operating Procedures, Quality Assurance and Quality Management Systems. The course also provides an introductory module on Community Engagement and Good Participatory Practice.
1.2 Good Clinical Laboratory Practice (GCLP)
This Training is designed to provide a comprehensive guidance and practical help for laboratories to improve their quality and offer excellent services to research participants and patients. The training addresses current regulatory framework for laboratory work in support of clinical trials as well public health laboratories with reference to the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. It also borrows from the BARQA guidance document on Good Clinical Laboratory Practice (GCLP) and WHO document on strengthening laboratory management to wards accreditation (SLMTA). The course is structured to encourage participants fulfill the following: discuss and develop ideas, solve specific problems related to their areas of laboratory work and examine particular aspects of GCP, GCLP and SLMTA.
The scope of training covers the following areas of laboratory practice: Introduction to GCLP, Organization and Personnel, Facilities, Equipment and Materials, Computer Validation, Document Control, Writing of a Standard SOP, Internal and External Quality Control, Assessment of Laboratory Supplies and Research Ethics.
1.3 Laboratory Quality Management Systems (LQMS)
In order to achieve the highest level of accuracy and reliability, it is essential to perform all processes and procedures in the laboratory in the best possible way. The laboratory is a complex system, involving many steps of activity and many people. The complexity of the system requires that many processes and procedures be performed properly. Therefore, the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance for basic research and patient care
Laboratory quality can be defined as accuracy, reliability, and timeliness of the reported test results. The laboratory results must be as accurate as possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in research, in clinical diagnosis and public health setting. This course is designed for managers of research as well as public health laboratories.
This training aims at equipping members of institutional review boards (IRB) with the necessary knowledge and skills for reviewing research and program proposals. In additions it equips the IRBs with necessary skills needed for accreditation It was developed in collaboration with the National Commission for Science, Technology and Innovation (NACOSTI), the Kenya national regulatory authority for research in Kenya at ministry of education
The scope of Bioethics training includes the following: Bioethics Practice, Conflict of Interest, Data Safety Monitoring Board, Essential Elements of a Research Proposal, Historical Perspectives, Informed Consent and Protection of Vulnerable Persons, Legal Aspects of Bioethics, Material Transfer Agreement, Minimum Standard of Care, National Ethics Review Guidelines, Protocol Review Process, Standard Operating Procedures, Study Designs and Clinical Trials, The Role of Ethics Committees.
1.5 Project Planning, Management and Evaluation
Knowledge and skills in project planning, implementation, management, monitoring and evaluation is critical in conducting research and implementing health care programs to the highest standards. This course is designed for post-graduate students, post-doctoral fellows, early career scientists, project managers, and implementers of research outcomes.
The WHO Implementation Research Tool Kit Facilitators Guide will form the foundation of the curriculum for the Project Planning, Management and Evaluation training. KAVI-ICR is cognisant of the fact that most of the implementation research implementers that it trains are adults, and therefore proposes an eclectic approach to the delivery of this course. Like others offered by KAVI-ICR, this course will make use of didactic, experiential and real life case pedagogical approaches. This training will make use of training slides, notes, case studies, open question and answer sessions, as well as group discussions and debates.
The two week Project Planning, management and Evaluation course is being developed through the collaboration of KAVI-ICR, University of Nairobi’s School of Public of Health, and Clinwin Research Service, a local CRO that trains health care professional and also provides support to clinical research.
Proposed Course Content – Project Planning, Management and Evaluation
•Introduction to Project Cycle Management and Project Management
•Problem Identification and use of ‘The Problem Tree’
•Assessment of the Context
•Research Projects vs. Implementation Research Projects
•Resources Identification and Planning
•The Logical Framework Approach and tools for project planning and management
•Proposal Writing and Budgeting
•Designing Monitoring and Evaluation Plans and other M&E tools
•Defining and Managing Project Assumptions
•Project Quality Management
•Project Management Software e.g Microsoft Project
•Regulation management (ensuring projects receive approvals from all applicable bodies)
•Reporting and close up of the project
•Introduction to Monitoring and Evaluation
•Differences between monitoring and evaluation
•Linking monitoring to evaluation
•Role of Monitoring and Evaluation in decision making
•Survey development and validation techniques,
•Assessment of modern and rapid testing methods;
•Budgets and resources utilization review
•Timelines and milestones achievements
1.6 Immunology and Vaccines Development
During our interaction with healthcare professionals and researchers in the East Africa region, the need for a short course in Immunology and Vaccines has been raised a number of times by participants. This is because the knowledge of immunology is crucial in the understanding of infectious diseases, and vaccines are critical in the control and prevention of many infectious diseases. KAVI-ICR took up the challenge and has just completed developing this course and intends to pilot in September 2014 before rolling it out starting December 2014.
The one week course will target: Clinicians, Pharmacists, Laboratory Scientists, Nurses, Public Health Professionals, Healthcare professionals interested in clinical aspects of vaccine delivery, Post-graduate students, Policy makers, Managers of vaccines and immunization programs, and Veterinary practitioners.
The objective is to strengthen the knowledge and understanding among healthcare professional within Sub Saharan Africa in the field of vaccines and immunizations and at the end equip participants with skills and knowledge in the concepts and principals of: how vaccines are made, why they made, how they are tested, how they work and new frontiers in vaccine research.
•Principles of Immunology and Vaccinology
•Vaccines and Immunization
•Vaccine Research & development
•Economics of Immunizations/Vaccines
•Ethics and Regulation of Vaccines
•Impact of Vaccines
•Future of Vaccines and Immunizations
1.7 Foundation Course in health research
This Two week course will provide participants with a basic understanding of the main issues in the design, conduct and interpretation of health research and programs. The course is intended to provide the participants
Clinical Research Methods
•Introduction to Epidemiology
•Introduction to study designs
Good Clinical Practice (GCP) and Research Ethics
•Introduction to GCP
•Role of ethics committees/ sponsors and investigators
•Informed consent process and vulnerable populations
•Safety assessment and reporting
Data Management and Basic Biostatistics
•Introduction to biostatistics
•Populations and sampling methods
•Types of variables (Data types, Data distribution, Measures of central tendency/measures of variability)
•Introduction to probability
•Introduction Diagnostic Tests (Screening)
•Statistical Inference (Hypothesis testing, Confidence intervals, Sample size calculation, Power calculations)
•Data analysis (Chi-square test, T-test and ANOVA, Linear Regression, Logistic Regression)
Good Clinical Laboratory Practice
•Introduction to GCLP
•Introduction to Quality assurance
•Standard Operating Procedures
•Introduction to GPP
•Community Advisory boards