Codelist management
A codelist is a predefined list of standardized codes representing specific responses or data points. The codelists are essential in the CRF design as they ensure consistency in data collection, making the data comparable across different subjects or time points.
The standardization facilitates the accurate analysis and interpretation of study results. The standardized nature of codelist items aids in reducing errors in the data entry process done in the EDC system. Moreover, codelists contribute to efficient data analysis and reporting as they enable data to be easily understood and verified by regulatory bodies.
The following example provides a brief overview of how codelists can be configured to meet study expectations for the collection of specific data. In a study to investigate the effectiveness of a new cream for treating dry skin, the study team creates a codelist CONDITION with code items: Improved, No Change, and Worsened.
In a Dermatological Assessment form, the team adds a corresponding variable to record participants' skin hydration levels before and after using the cream and associate it with the CONDITION codelist. By limiting the codelist to three clear options, researchers can efficiently analyze the data to determine the impact of cream on skin hydration based on subjects' responses in EDC.
In the Study Designer application, you can create and manage codelists according to study requirements and data collection objectives. The configuration of all study codelists is done under the CODELIST tab of the application.
When working with codelists, you can perform the following important actions: