CTSG’s project management activities are crucial to the development and delivery of MORU’s clinical trials in a safe, legal and ethical way.
Clinical Trial Preparation
CTSG is involved in developing the clinical trial or study from the start, working with principal investigators to develop protocols and key trial documents like patient information sheets, questionnaires, informed consent forms and summary of medical product characteristics.
The CTSG team also manages the submission of studies to the Oxford Tropical Reseach Ethics Committee (OXTREC) and Faculty of Tropical Medicine Ethics Committee at Mahidol University (FTME) for ethical approval. In addition, the team also provides submission packages to the study leads in other countries where the trial will be conducted for translation and sumbission to the approriate ethics committees and if relevant, national regulatory authorities. These complex processes vary between locations, so CTSG’s experience working in Asia and Africa helps to ensure that trials have met all legal and ethical requirements in all participating countries.
Site Management and Monitoring
Once the study has the necessary approvals in place and sites are ready to open a study, CTSG provides site management and monitoring expertise. CTSG make Site Initiation Visits (SIVs) to train site staff in trial protocols, data management, trial documentation and Good Clinical Practice (GCP).
As the trial progresses, CTSG carries out further monitoring visits across study locations such as local field clinics, community health services and urban hospitals both to support site staff and quality assure the data. CTSG staff work with delivery partners to ensure that trial protocols are followed and the reporting requirements for pharmacovigilance are met.
Project Management Tools
CTSG’s management processes are underpinned by its Integrated Research Information System (IRIS) and online document repository. IRIS includes all research projects, information on ethics applications, funding applications, and study staff, visitors and students.