Clinical Data Management
Clinical Data Management (CDM) is an integral part of clinical research as it ensures high-quality, consistent, and statistically analysable data in compliance with regulatory requirements. To produce such sound data, CDM processes generally start in the early development stages of a clinical trial, and they run till the trial completion. Processes include designing the Case Report Forms (CRF); paper and electronic, database (DB) build, Electronic Data Capture (EDC) training, support and maintenance of the live DB, data review and validation, medical coding, data extraction and cleaning, preparing the data for statistical analysis, curation, decommissioning and archiving. Our Cancer Trials New Zealand (CTNZ) DM team balances these processes throughout the lifecycle of a clinical trial with the help of accurate planning, inclusive data management structure, and great teamwork.
In the next newsletter, we will briefly introduce our first main process: Database Planning and Development.