Introduction to Standards

Standards establish a framework for how clinical trial data are structured, named, and organized, promoting collaboration between study sites, data teams, researchers, and regulators. The Clinical Data Interchange Standards Consortium (CDISC) develops and maintains several standards for clinical research, covering everything from initial data capture to analysis-ready datasets.

• Clinical Data Acquisition Standards Harmonization (CDASH) defines standardized fields for data collection.
• Study Data Tabulation Model (SDTM) emphasizes the organization of trial data for regulatory submissions and reporting.
• Analysis Data Model (ADaM) offers guidelines for preparing datasets used in statistical analysis. 

Within the Standards module, users can easily browse and search these CDISC standards without needing to switch between systems. In addition to the included CDISC standards, users can manually upload custom standards or import them (synchronize) with an MDR system. 

Standards can be used in other elluminate modules as follows:

• Mapper to guide users in mapping to defined standards (e.g., SDTM, ADaM). Mapping to these standards ensures consistency and helps prevent errors.
• Validator for data conformance.
• Specifications as a foundational document when building specifications.

Access Standards

1. Access Standards from the Platform Menu under Metadata Management. The available standards are listed at the left of the window (referred to as the Standards tree).
2. Click on a Standard, such as SDTM 3.3, for example. This displays the information for the version selected. Notice the Standard type and version listed at the top left of the window.
   
3. Click on any of the links within the main window to drill down and find out more information. You can drill down on fields such as Observation Class, Domain Name, Code List, Data Structure Name, and Dataset Name; depending on the Standard you are browsing. In the example shown, the Domain Name column has active links to more information.
4. For example, drill down on a domain name, and then look up the Code List for a particular variable. The example shown below shows the SDTM version 3.3, in the CM domain, and displaying information about the Code List for NY on the variable CM Occurrence.
   
5. To identify if the Code List has changed for a version, click the drop-down in the Controlled Terminology Version field to see the changes.
   

Use Search Functionality

The search functionality in the Standards module allows you to easily find the information you are looking for. Use the fields located at the top to select items such as the Controlled Terminology Version, Standard, Domains, and free text search to limit your results.

1. Select the Standard you want to search through using the Select Standards drop-down. By default, all are selected.
   
2. Click in the Domains drop-down to select between searching in Domains, Variables, Code Lists, or CT Values; Domains is the default.
   
3. Click in the Search field and enter what you want to find, such as AE.
4. Click the Magnifying Glass or press Enter.
5. The results display, and the Standards are separated by tabs at the top of the list.
6. To view more information on your search results, click on the tab for the standard you want to review, and then click on the link in the Domain Name column for more information.  For example, click the AE link in the Domain Name column for the SDTM standard.
   
7. Click the Controlled Terminology Version drop-down to change the date. (This is helpful when looking at the Controlled Terminology Version for corresponding Codelist values.)
8. Click the Reset button at the top right corner to clear your search criteria.