Data Standards
Background
A common issue in medical research is the frequency with which investigators “reinvent the wheel.” Data collection instruments are commonly reused within the projects of a single study team, but teams often build new instruments from scratch with only limited consideration for efficiency and reuse of common variables. Clinical trials data management operations such as study monitoring, data collection, cleaning, and reporting become easier when study staff is working with familiar tools and instruments. In the modern research environment, secondary use is becoming more common, and data from several studies may be combined in meta-analysis. Such operations are simpler to perform when there is clear documentation and metadata available for the study data set.
By adopting and adhering to standardized data collection practices, we aim to streamline data management processes, enhance the efficiency of clinical trials, and facilitate the secondary use of data. This approach not only supports individual research projects but also contributes to the broader scientific community by enabling easier data sharing and integration for meta-analyses and other collaborative research efforts.
Standardization Approach
The Clinical Data Interchange Standards Consortium (CDISC ) document a number of data models, one of which is CDASH. This is specifically intended to standardize data collection across studies, investigators, and sponsors, thereby increasing efficiency while enhancing interoperability and facilitating secondary use. It is the intention of the WCHRI DCC to be CDASH compliant where practical, without imposing additional burden or complexity on study teams and database developers.
In recommending a data standard to be adopted at the WCHRI DCC, we have decided on the following general approach:
Adopt CDASH Guidance Where Practical: We will implement CDASH standards as much as possible, while allowing for variations specific to Canadian contexts and the use of REDCap.
Use CDASH Definitions When Available: For variables that are defined in a CDASH Implementation Guide (CDASHIG), we will use the CDASH definitions.
Develop WCHRI-Specific Variables When Necessary: In cases where there is no appropriate CDASH definition, we will create variables based on WCHRI DCC rules. These rules are influenced by CDASH recommendations and are described in detail in our standards document.
More information about CDASH can be found here: CDASH Standards.
Database Configuration Standards.pdfInstrument Templates
We are in the process of building a set of instrument templates based on these standards. Researchers that are affiliated with the University of Alberta or the WCHRI Data Coordinating Centre may request copies of these instruments for use in their projects. Some instruments are proprietary. We cannot distribute these without prior permission.
The data standards project is a collaboration between the Women and Children’s Health Research Institute, the Maternal Infant Child and Youth Research Network with funding from the Accelerating Clinical Trials Consortium.
