The operations team is responsible for implementing and managing clinical study activities to support MORU investigators. This includes:
- Handling regulatory submissions for initial protocols and ongoing correspondence with both central and local ethics committees
- Development of study procedures and documentation and systems necessary to initiate and run studies
- Conduct of study-specific and general GCP training
- On-site and remote monitoring of clinical studies to ensure compliance
- Provide project management services to investigators, including tracking milestones and document management
This team provides programming and data management support for studies conducted in MORU. The team includes data managers, data entry staff, programmers and database administrators who provide the following services:
- Development of project-specific data management and sharing plans
- Case Report Form and Questionnaire design
- Database design, validation and maintenance
- Data entry
- Data cleaning and quality management
- Coding and standardization of datasets
- Database lock
- Archiving and long-term preservation of data
- Advice and technical support for data sharing
In addition, the team collaborates with researchers to develop bespoke software applications and websites.
The CTSG Statistics team analyses and advises on all statistical elements of MORU’s clinical trials.
The CTSG Statistics team works closely with key researchers to develop the study’s statistics plan, ensuring that data capture and recording methods are suitable and that planned analysis is frequent and robust enough to meet the study’s objectives.
During a clinical trial, interim statistical analyses are key to on-going progress. The CTSG Statistics and Data Management teams work closely with project leads to undertake periodic reviews. When trials are under oversight by a Data Safety Monitoring Board, the Statistics Team prepares appropriate reports.
Upon trial completion, the Statistics team prepares for publication the full statistical analysis of data collected during the trial. This enables critical insight and evaluation to inform further research questions.