The operations team is responsible for implementing and managing clinical trials conducted at collaborating hospitals. The team supports investigators to develop study procedures, documentation and systems necessary to initiate and run studies. They help to coordinate the different departments involved in the trial, oversee the collection of clinical data and research specimens and will have clinical and operational oversight of trial conduct. The operations team includes research coordinators, study nurses and study doctors. The data management team, the pharmacy team and the study coordinators are all also part of the operations team.
Data Management Team
The purpose of all the work that goes into a research study is to collect reliable data to inform health improvements. The data team ensures that the data collected is complete, accurate and protected. Our data team design a data management plan for each study which determines:
- where the data comes from;
- who collects it; and
- how it is captured.
The data team also ensures that data is accurately entered into the study database. This team understands information technology and finds the best ways to use new software and devices to improve research. Team members include: Data Team Leader and Data Entry Staff.
OUCRU is running a large number of international randomized, double-blind, placebo controlled clinical trials of new treatments. Across Asia and Africa, the medicines used in all OUCRU trials are selected, placebo matched, blinded, packaged and controlled by the Pharmacy Team. This team is key to ensuring that the right drugs are tested on the right patients in a safe way and that the results from our trials determine the best possible treatment for patients. Team members include: Pharmacy Team Leader, Pharmacy Coordinators.
The study coordinators implement and manage clinical trials conducted at OUCRU collaborating hospitals. The coordinators support investigators to develop the study procedures, documentation and systems necessary to initiate and run the study. They help to coordinate the different departments involved in the trial, oversee the collection of clinical data and research specimens and will have clinical and operational oversight of trial conduct.
The Governance Team is responsible for handling all ethical and regulatory submissions for the Unit. This has allowed us to train experts who have developed close relationships with the local authorities managing the approvals and defining policies. We have a qualified monitoring team who support the sites to ensure quality in our work and we have centralized budgets and contracts to provide an efficient and transparent process. The Governance Team includes Research Coordinators, Study Nurses and Study Doctors.
The Research Monitors work with study staff at the research sties to ensure that research is executed to the highest international quality standards and according to the study protocol, ethical guidelines and appropriate regulations. The monitors support research sites to build clinical trials capacity. Team members include: Senior Monitors.
Ethics & Regulatory Team
The Ethics & Regulatory Team is responsible for ensuring that the research conducted by OUCRU-VN is ethically designed and approved by the appropriate authorities. The Team guides studies through the required approval processes, prepares study documentation, tracks study progress, maintains approvals and documentation during the study and liaises with the study site to ensure the study is compliant with appropriate standards. Team members include: Senior Research Associates, Research Associates, and Research Administrator.
The Contract Team plans research budgets and arranges contracts to cover funding, management and intellectual property. The Team supports study documentation and ensures that the requirements of local and international laws are met. Team members include: Contracts Specialist, Contract Administrator.