The ClinOps training program is an intensive on-the-job training initiative specifically designed for study coordinators operating in Low- and Middle-Income Countries (LMICs), and coordinated by the Center for Innovative Drug Development and Therapeutic Trials (CDT-Africa), Addis Ababa University. This comprehensive program has been meticulously crafted utilizing training materials and resources sourced from reputable institutions such as The Global Health Network, TDR Regional Training Centers, University of Siena, and other similar organizations. Commencing in 2017, this program has been successfully conducted on five separate occasions through the collaborative efforts of various key stakeholders. These organizations have played an integral role in not only shaping and delivering the program but also in its ongoing enhancement through a structured monitoring and evaluation framework. The esteemed collaborators include the Faculty of Capacity Development (FCD), FIND, Medicines for Malaria Ventures (MMV), IAVI, PATH, the Special Programme for Research and Training in Tropical Diseases (TDR), and TB Alliance.
To date, the program has provided training to a total of 365 students hailing from over 30 different countries across Africa, Asia, and Latin America.
The core learning objectives of this program encompass:
- Prepare the research sites for clinical trial start-up through an overall understanding of the clinical trial process from project management to trial design and protocol development.
- Demonstrate the ability to conduct GCP-compliant clinical trials in conformance with ethical principles using patient recruitment and retention approaches, data management, data monitoring, pharmacovigilance, and safety reporting.
- Design and maintain the quality system of a clinical trial through implementing SOPs, risk management approaches, handling audits and inspections, as well as other aspects of quality control and quality assurance.
- Identify and address key challenges in managing the research sites including developing and maintaining capacity, retaining research staff, community engagement, and managing grants.
- Develop people management skills and techniques that are useful in working with internal colleagues and external partners
- Efficiently close out clinical trials, handle post-trial responsibilities and report results in a timely manner
Structure of the course
This program is conducted online and consists of a series of 10 consecutive lessons (refer to Table 1). The content is delivered through a variety of engaging methods, including interactive recorded presentations, live and asynchronous tutorials, discussion forums, and personalized mentoring sessions.
| Week | Lesson Title |
| 1 | Introduction to Clinical Trial Operations |
| 2 | Data Management and Biostatistics |
| 3 | Study Design and Protocol Development |
| 4 | Conducting a Trial 1* |
| 5 | Conducting a Trial 2** |
| 6 | Closing out and Reporting a Trial |
| 7 | Project and Financial Management |
| 8 | Working with External Partners |
| 9 | Quality Systems, Audits & Inspections |
| 10 | Pharmacovigilance |
Unique features of the ClinOps Training
The ClinOps training program boasts a range of distinctive features that set it apart. The curriculum is meticulously crafted based on the TDR/TGHN competency framework, comprehensively covering all aspects of clinical trials to equip trainees with the necessary skills to effectively conduct trials. Moreover, the program benefits from valuable insights provided by key stakeholders such as Product Development Partners (PDPs), Contract Research Organizations (CROs), and the Faculty of Capacity Development (FCD).
Emphasizing practical challenges commonly encountered at sites in Low- and Middle-Income Countries (LMICs), the training program employs innovative approaches to course delivery. It incorporates a robust measurement and evaluation component to facilitate continuous enhancement. A pivotal aspect of the learning process involves sharing experiences through forum discussions among trainees. Additionally, the "common findings" section in each lesson aids in preparing students to identify and address prevalent issues in their day-to-day clinical trial activities.
Through collaborative group work, trainees collaborate on developing a risk management plan. This exercise not only enhances their ability to identify risks but also equips them with strategies for effective risk mitigation.
The open access version of the ClinOps training could be accessed through the following link. https://lms.cdt-africa.org/login/index.php, Login as guest and then on the next page click on “Open Access Study Coordinator's Course”
Support the training program
We are soliciting collaborators on this training initiative and you may support the training through financial and in-kind support. Please contact the program leader at This email address is being protected from spambots. You need JavaScript enabled to view it.