.

SDTM Dataset Structure Documentation: A Senior Programmer's Perspective Introduction: Why I'm Writing This After spending over 15 years mapping clinical data to SDTM, I've seen firsthand how proper dataset structure documentation can make or break a submission. Recently, I encountered a situation where incomplete structure descriptions in Define.xml led to significant rework in a late-phase study. This experience prompted me to share my insights on why meticulous documentation of dataset structures is crucial. The Real-World Impact of Structure Documentation Let me share a recent example from my work. We inherited a study where the LB domain structure was documented simply as: "One record per analyte per planned time point per visit per subject" However, the key variables included: ...

Mastering the Art of Comments in Define.xml: Your Ultimate Guide to Clinical Data Documentation Posted by Sarath In the world of clinical data management, the define.xml file serves as the cornerstone of dataset documentation. While most professionals focus on the basic structural elements, the Comments tab often remains an underutilized goldmine of information. Today, we'll dive deep into how to leverage this powerful feature to enhance your clinical data documentation. Quick Takeaway: Well-crafted comments in your define.xml can significantly reduce queries during regulatory submissions and streamline the review process. Why Comments Matter in Define.xml The Comments tab isn't just an afterthought - it's your opportunity to provide crucial context that doesn't fit neatly into other standardized fields. Think of i...

By StudySAS Team | January 7, 2025 Introduction to SDTM Domains In clinical data management, the Study Data Tabulation Model (SDTM) is a crucial standard for organizing and formatting data to streamline regulatory submissions. Among its various domains, the EX (Exposure) and EC (Exposure Events) domains play significant roles in documenting participant exposures and related events during a study. This blog post delves into when and how to annotate these domains, providing detailed examples and best practices based on the SDTM Implementation Guide (IG) Version 3.3 . Understanding the EX Domain The EX (Exposure) domain is essential for capturing detailed information about the administration of investigational products, concomitant medications, or other exposures participants receive during a clinical study. ...

Key Concept: The decision to map protocol version information in SDTM Disposition (DS) domain requires careful analysis of its relationship to disposition events and understanding of data management requirements. Understanding Protocol Version's Role in Disposition Events Protocol versions can significantly impact disposition events in clinical trials. Their relationship to these events determines the appropriate mapping strategy within the SDTM structure. This relationship can be categorized into two main types: Direct Impact Relationship When protocol version changes directly cause or influence disposition events, such as: Subject withdrawal due to protocol amendment modifications Study discontinuation resulting from significant protocol changes Protocol-mandated subject transfers between treatment arms Contextual Relationship When proto...

In the world of clinical trials, data management and standardization play crucial roles in ensuring the quality and integrity of research outcomes. One particularly nuanced aspect of this process is the proper assignment of EPOCH values in SDTM (Study Data Tabulation Model) datasets, especially when dealing with pre-consent data. What is an EPOCH? An EPOCH in clinical trials represents a distinct period within the study's planned design. It helps organize and contextualize various events, interventions, and findings that occur during the study. Common EPOCHs include SCREENING, TREATMENT, FOLLOW-UP, and others as defined by the study protocol. Essential EPOCH Characteristics: It is a standardized way to identify different phases of a study Each EPOCH represents a planned element of the study design EPOCHs help establish temporal relationships between different study e...

The Critical Role of ODS LISTING Close Statements in SAS: Avoiding Comment Width Errors One of the common challenges SAS programmers face is encountering the error message: "ERROR: Comment width is not between 1 and 200 characters." This error, while seemingly straightforward, can be particularly frustrating when it appears unexpectedly in your SAS log. In this article, we'll dive deep into understanding this error and how proper management of ODS LISTING statements can help you avoid it. Introduction to ODS The Output Delivery System (ODS) in SAS enables users to control the appearance and destination of output generated by SAS procedures. ODS allows output to be directed to various destinations like HTML, PDF, RTF, and the default Listing destination. Proper management of these destinations is critical to ensuring clean output and avoiding errors. Understanding the Error The error message regarding commen...