Headed by Ng Xuan Hui
Data Management services comprise:
- Creation and design of Case Report Forms (CRF) based on requirements of clinical trial protocol
- Design and development of study database
- Design and writing of data validation programmes for complex clinical data checks
- Development of CRF Completion Guidelines
- Data cleaning and query management to ensure integrity and accuracy of study data
- Training of study site personnel in data entry skills to ensure quality of study data
- Clinical Data Management System (CDMS) known as Oracle Clinical (OC), with a Remote Data Capture (RDC) application that allows data to be recorded directly at study sites
- Medical coding such as dictionary coding to enable classification of medical events and medications under the rules of established dictionaries (e.g. MedDRA and WHO Drug Dictionary)
- Use of business analytics and intelligence software called SAS Enterprise Guide for reporting of comprehensive data matrices
Specialised skills in Data Management are a rarity in Singapore’s clinical research scene.
To adequately support internal and external stakeholders in clinical research, SCRI’s Data Management team offers system training and skilful planning to ensure the integrity of data during a study.
Efficiency and intuitive usage of data management systems are also important towards streamlining the data gathering process, and the team strives to support this via development of electronic Case Report Forms (CRF) and project guides such as the RDC Users’ Self Help Guide. Validated international dictionaries such as the MedDRA and WHO Drug Dictionary are utilised to standardise medical terminology and drug names used in a study database.
When in place, these measures help to ensure a common language and stability throughout a study. Besides driving productivity at study sites, site staff can invest more time with study subjects instead of keying large quantity of
information into the database.
To ensure that study data is thoroughly assessed, a comprehensive data management plan and study data matrices reports for principal investigators
and project managers can be generated by the Data Management team.
The team utilises the Oracle Clinical system to manage clinical studies and systemise the keying of information into databases. For added focus during collection of data variables for analysis, user guides such as the CRF Completion Guidelines can be established.
It is important to sustain a pool of talents in the furtherance of clinical research excellence for the future. In light of this, the department has an ongoing partnership with Nanyang Polytechnic to provide internship programmes and introduce youths to a fulfilling Data Management career path in clinical research.