Harnessing the Power of NCI/CDISC Controlled Terminology for FDA Submission in Clinical Research
Clinical research is a complex and highly regulated domain that requires a well-structured approach to data management and analysis. Standardization of data is crucial for ensuring the quality, reliability, and interoperability of research outcomes. The National Cancer Institute (NCI) and Clinical Data Interchange Standards Consortium (CDISC) have collaborated to develop a comprehensive controlled terminology that facilitates the standardization and harmonization of clinical data in research and regulatory submissions. This article delves into the intricate world of NCI/CDISC controlled terminology and its implementation for FDA submission in clinical research.
Overview of NCI/CDISC Controlled Terminology
The NCI Enterprise Vocabulary Services (EVS) maintains and distributes the controlled terminology for the CDISC Study Data Tabulation Model (SDTM). The terminology is available in various formats, including Excel, text, odm.xml, pdf, html, and OWL/RDF. CDISC Questionnaires, Ratings, and Scales (QRS) Terminology has been merged into SDTM terminology since the 2015–12–18 release.
The NCI/CDISC controlled terminology spreadsheet consists of various columns, such as Code, Codelist, Codelist Extensible, Codelist Name, CDISC Submission Value, CDISC Synonym(s), CDISC Definition, and NCI Preferred Term. These columns provide essential information about the terms and their relationships within the controlled vocabulary.
SDTM Programming Specifications Spreadsheet
The SDTM Programming Specifications Spreadsheet serves as a guide for converting raw data into SDTM format. It contains SAS Global Macro Variables, such as &label, &keep, &label_supp, &keep_supp, &attrib, &attrib_supp, which are used to populate the SDTM dataset. The spreadsheet also provides instructions for generating Define-xml files for FDA submission and performing automatic consistency checking of controlled terminology among SDTM datasets, Define.xml, and NCI/CDISC controlled terminology.
Converting Controlled Terminology into SAS Data
To facilitate the implementation of controlled terminology in clinical research, the NCI/CDISC controlled terminology spreadsheet is converted into a SAS data file. This conversion ensures that the data structure and content remain consistent with the source spreadsheet. However, for questionnaires, the Variable ‘CODELIST’ is changed to QSTESTCD or QSTEST to align with the codelist names assigned in SDTM Implementation Guide (IG).
Implementing Controlled Terminology in SDTM Datasets
Controlled terminology is incorporated into the main domain and supplemental domain datasets in accordance with the information provided in the dataset and specification. The SAS data generated from the NCI/CDISC controlled terminology spreadsheet serves as a source of standard controlled terminology in the research library.
Automatic Consistency Checking for FDA Submission
Ensuring consistency between controlled terminology, SDTM datasets, and Define.xml files is critical for successful FDA submission. An automated process is employed to perform consistency checking, which involves the following steps:
- Reporting any mismatches between controlled terminology and SDTM datasets or Define.xml files
- Accepting or fixing mismatches as needed
- Finalizing SDTM programming
Additionally, the process includes reporting any updates from the previous version of the NCI/CDISC controlled terminology spreadsheet and updating the CT Worksheet accordingly.
Conclusion
The NCI/CDISC controlled terminology is an essential tool in the realm of clinical research, ensuring data standardization, harmonization, and regulatory compliance. By converting the controlled terminology into a SAS data file and implementing it in SDTM datasets, researchers can maintain consistency and improve data quality across their studies.
