FDA Standards & Requirements for the Creation and Submission of Clinical Trial Datasets
Date: August 26, 2026
Duration: 60 Minutes
Time: 12 PM EST
Overview
The success of a clinical trial submission depends not only on the quality of the clinical data collected but also on how effectively that data is organized, standardized, analyzed, and submitted to the FDA. In recent years, the FDA has significantly strengthened its expectations regarding study data standardization, requiring sponsors to submit clinical trial datasets in formats that support efficient review, analysis, traceability, and regulatory decision-making. Failure to comply with these requirements can result in technical rejection, delays in review, additional information requests, and increased regulatory risk.
This webinar provides a comprehensive understanding of FDA requirements for creating, validating, documenting, and submitting clinical trial datasets for INDs, NDAs, BLAs, and other regulatory submissions. Participants will learn how to develop submission-ready datasets using CDISC standards, prepare compliant metadata, create traceable analysis datasets, and successfully navigate FDA technical conformance requirements.
The program will cover the complete data journey—from data collection and tabulation through statistical analysis and electronic submission—while highlighting common compliance issues, validation challenges, and best practices that can help organizations avoid costly delays and improve submission quality.
Why This Webinar Matters
The FDA requires standardized study data submissions for most clinical trials submitted to CDER and CBER. Regulatory reviewers increasingly rely on standardized datasets to conduct efficient analyses, reproduce study results, assess safety signals, and verify sponsor conclusions. The FDA may refuse to file or receive submissions that fail to meet applicable data standards and technical conformance requirements.
Organizations involved in clinical development must therefore understand:
- FDA data standard requirements
- CDISC implementation expectations
- SDTM and ADaM dataset creation
- Define.xml metadata preparation
- Dataset validation procedures
- Technical rejection criteria
- eCTD study data submission requirements
A proactive approach to data standardization can significantly reduce review cycles, improve submission quality, and strengthen regulatory confidence.
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Topics to Be Covered
- FDA Regulatory Framework for Clinical Trial Datasets
- Understanding CDISC Standards Required by FDA
- Creating FDA-Compliant SDTM Datasets
- Developing Analysis-Ready ADaM Datasets
- Metadata and Define.xml Requirements
- Dataset Validation and Quality Assurance
- Electronic Submission Requirements
- Common Deficiencies Observed by FDA
- Best Practices for Submission Success
Key Learning Outcomes
By attending this webinar, participants will be able to:
- Understand FDA requirements for clinical trial dataset submissions.
- Apply CDISC SDTM and ADaM standards effectively.
- Create compliant and traceable clinical datasets.
- Develop Define.xml and supporting metadata documentation.
- Avoid common validation and submission errors.
- Meet FDA technical conformance expectations.
- Improve submission quality and reduce regulatory review risks.
- Build a sustainable strategy for study data standardization across clinical development programs.
This practical and regulatory-focused webinar will equip attendees with the knowledge needed to create FDA-compliant, submission-ready clinical trial datasets that support efficient regulatory review and successful product approvals.
Who Should Attend?
- Clinical Data Managers
- Clinical Programmers
- Statistical Programmers
- Biostatisticians
- Quality Assurance Professionals
- Regulatory Affairs Professionals
- Clinical Operations Teams
- Data Standards Specialists
- CRO Project Managers
- Clinical Research Scientists
- Regulatory Submission Teams
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
We accept credit card, debit card, and PayPal.
Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
