What does the Study Data Tabulation Model (SDTM) guide?

The Study Data Tabulation Model (SDTM) guide primarily focuses on the organization of clinical trial tabulation datasets. It provides standardized formats and terminology for the collection, management, and submission of clinical trial data, ensuring that the data can be efficiently interpreted and analyzed across different studies and organizations. By adhering to SDTM, sponsors of clinical trials can present data in a consistent way, which facilitates regulatory review and enhances the clarity of the information being shared with stakeholders.

The SDTM framework outlines how data should be structured, including aspects like variable naming conventions, dataset organization, and required metadata. This promotes uniformity across clinical trial data submissions, making it easier for regulatory agencies like the FDA to review and evaluate the submitted data.

While the other options refer to important aspects of clinical trials, they do not align with the focus of the SDTM. For instance, laboratory data submissions and informed consent documents have their own specific guidelines and structures that do not fall under the SDTM framework. Similarly, patient questionnaires focus on data collection methods rather than the organization of tabulated datasets.