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SDTM aCRF Annotation Checklist SDTM aCRF Annotation Checklist By Sarath Annapareddy Introduction Creating an SDTM Annotated Case Report Form (aCRF) is a critical step in clinical trial data submission. It ensures that data collected in the CRF maps correctly to SDTM domains, adhering to regulatory and CDISC standards. This checklist serves as a guide to creating a high-quality SDTM aCRF ready for regulatory submission. 1. General Formatting Ensure the aCRF uses the latest SDTM IG version relevant to the study. The document should be clean, legible, and free of overlapping annotations. Page numbers in the aCRF should align with the actual CRF pages. Annotations must be in English, clear, and consistently for...

Common P21 SDTM Compliance Issues and How to Resolve Them Common P21 SDTM Compliance Issues and How to Resolve Them By Sarath Annapareddy Introduction Pinnacle 21 (P21) is a cornerstone for validating SDTM datasets against CDISC standards. Its checks ensure compliance with regulatory requirements set by the FDA, PMDA, and other authorities. However, resolving the issues flagged by P21 can be challenging, especially for beginners. This post dives into common P21 compliance issues and provides actionable solutions with examples. 1. Missing or Invalid Controlled Terminology Issue: P21 flags variables like LBTESTCD or SEX as non-compliant with CDISC Controlled Terminology (CT). This happens when values in your datasets are o...

Define.xml and cSDRG QC Checklist for FDA and PMDA Submissions Comprehensive QC Checklist for Define.xml and cSDRG Ensuring Quality and Compliance for FDA and PMDA SDTM Submissions Introduction The Define.xml and Clinical Study Data Reviewer’s Guide (cSDRG) are critical components of SDTM submissions to regulatory agencies like the FDA and PMDA. These documents help reviewers understand the structure, content, and traceability of the datasets submitted. A robust QC process ensures compliance with agency requirements, minimizes errors, and enhances submission success. This blog outlines a detailed manual QC checklist for both Define.xml and cSDRG, emphasizing key differences between FDA and PMDA requirements. Define.xml QC Checklist 1. Metadata Verification Verify all datas...

FDA vs PMDA Data Quality Checks Differences in Data Quality Checks Between FDA and PMDA Introduction Submitting SDTM datasets to regulatory authorities like the FDA (U.S. Food and Drug Administration) and PMDA (Japan's Pharmaceuticals and Medical Devices Agency) involves rigorous data quality checks. While both agencies adhere to CDISC standards, their submission guidelines and expectations differ in certain aspects. This blog explores the key differences in data quality checks for FDA and PMDA submissions. Similarities in Data Quality Checks Both FDA and PMDA share several common expectations for SDTM datasets: Adherence to CDISC Standards: Both agencies require compliance with the SDTM Implementation Guide (SDTM-IG). Controlled Terminology (CT): Variables such as AEDECOD and LBTESTCD must align with CDISC CT. Traceability: Ensures that derived datasets and analysis results can be traced back to ...

Advanced SDTM Programming Tips Advanced SDTM Programming Tips Streamline Your SDTM Development with Expert Techniques Tip 1: Automating SUPPQUAL Domain Creation The SUPPQUAL (Supplemental Qualifiers) domain can be automated using SAS macros to handle additional variables in a systematic way. Refer to the macro example provided earlier to simplify your SUPPQUAL generation process. Tip 2: Handling Date Imputation Many SDTM domains require complete dates, but raw data often contains partial or missing dates. Use the following code snippet for date imputation: data imputed_dates; set raw_data; /* Impute missing day to the first day of the month */ if length(strip(date)) = 7 then date = cats(date, '-01'); /* Impute missing...

Advanced SDTM Programming Tip: Automating SUPPQUAL Domain Creation Advanced SDTM Programming Tip: Automating SUPPQUAL Domain Creation Optimize Your SDTM Workflows with Efficient Automation Techniques Introduction to SUPPQUAL Automation The SUPPQUAL (Supplemental Qualifiers) domain is used to store additional information that cannot fit within a standard SDTM domain. Manually creating the SUPPQUAL domain can be time-consuming and error-prone, especially for large datasets. In this article, we’ll explore an advanced tip to automate its creation using SAS macros. Use Case: Adding Supplemental Qualifiers to a Domain Imagine you have an SDTM AE domain (Adverse Events) and need to capture additional details like the investigator’s comments or assessment methods that are not part of the stan...

Advanced SAS Programming Tip: Using HASH Objects Advanced SAS Programming Tip: Using HASH Objects Unlock the Power of SAS for Efficient Data Manipulation Introduction to HASH Objects In SAS, HASH objects provide an efficient way to perform in-memory data lookups and merge operations, especially when dealing with large datasets. Unlike traditional joins using PROC SQL or the MERGE statement, HASH objects can significantly reduce computational overhead. Use Case: Matching and Merging Large Datasets Suppose you have two datasets: a master dataset containing millions of records and a lookup dataset with unique key-value pairs. The goal is to merge these datasets without compromising performance. Code Example: Using HASH...