Conference: PharmaSUG 2025 Conference
日期 June 1-4, 2025
地点 San Diego, CA
展位： #306, #405
Sponsor: Gold
Where to hear Certara insights and Expertise
Author: Michael Beers - Director, Consultative Services
摘要： When preparing a submission package for the Bioresearch Monitoring (BIMO) Clinical Site (CLINSITE) Dataset, it is important to ensure compliance to the FDA’s specifications and guidance. It is often the case, however, that issues exist with the CLINSITE dataset and the associated documentation. This paper will review some of the most common issues seen across the industry, and how the issues should be addressed.
Author: Kristin Kelly - Senior Principal CDISC Consultant
摘要： Though the CDISC SDTM Implementation Guide provides advice on how to prepare SDTM datasets for completed studies, there is little guidance on what to do when the study is ongoing, leading to varied implementation practices across the industry. At times, it may be difficult for a regulatory reviewer to readily determine that a study is still in progress without looking in the Clinical Study Data Reviewer’s Guide (cSDRG). The recent addition of the ONGOSIND (Ongoing Study Indicator) parameter in the FDA Study Data Technical Conformance Guide (sdTCG) allows sponsors to clearly specify within the data whether a study is ongoing. In this paper, some considerations for preparing domains such as Demographics (DM), Disposition (DS), and Trial Summary (TS) for an ongoing study as well as strategies to ensure data transparency across the SDTM submission package will be discussed.
Authors: Julie Ann Hood- Principal CDISC Consultant and Seiko Yamazaki - Senior CDISC Consultant
摘要： Preparing SDTM and ADaM data packages for submissions can be a daunting task. With all the guidance documentation and checks for files and data needed for submission, it’s easy to get overwhelmed. This presentation will highlight essential documents to reference for submissions to both FDA and PMDA. A focus will be placed on key review items for non-automated checks, as well as critical cross-checks spanning both study data and submission documents to serve as a foundational resource. Attendees will be able to leverage this framework to create a more comprehensive checklist that will enhance their organization’s own submission process.
