The Clinical Trials Support Group (CTSG) was formally established in 2008 to provide help, guidance, and support to MORU researchers who are involved in any studies involving human subjects. It is led by Dr Phaikyeong Cheah, and currently comprises a group of experienced Clinical Trial Coordinators who support clinical trials throughout the MOP, irrespective of geography or discipline.

  GCP monitoring of a clinical trial in Maela Refugee Camp

CTSG provides assistance in planning, implementing, and managing research activities, as well as compliance with Good Clinical Practice (GCP) and local requirements through the following activities:

• Assisting the development of the research protocol, information sheet, consent form, case report forms (CRFs), standard operating procedures and other associated documents in compliance with Good Clinical Practice, Oxford University and local regulatory requirements

• Assisting and facilitating submission to ethics committees (including the Oxford Tropical Research Ethics Committee) and local regulatory authorities. This includes submissions, resubmissions, amendments, serious adverse event reports, annual reports, safety and closure reports.

• Providing project management and administrative, logistic and data management support to large clinical trials

• Providing GCP, human subject protection, ethics, monitoring, and other associated training in an effort to build capacity in collaborative sites.

• Assist in overall quality management of clinical trials. This includes providing on site risk approach fit-for-purpose GCP monitoring to clinical research sites.

• Assisting in the development and training of a community engagement programme on the Thai-Burmese border.

CTSG has developed a clinical research database (Clinical Trial Management System or CTMS) for the tracking of all research projects through all stages of scientific, ethical and regulatory review. The system also enables rapid reporting of clinical trials activity of all or part of the MOP, and alerts investigators of any pending tasks, such as writing annual reports to ethics committees and ensuring trial registry compliance.