CDISC Standards: A Crucial Requirement for FDA Submissions in Clinical Research

CDISC standards have become an integral part of the clinical research process, particularly in regulatory submissions to the US Food and Drug Administration (FDA). These standards, developed by the Clinical Data Interchange Standards Consortium (CDISC), play a crucial role in streamlining data collection, analysis, and submission in clinical trials. For pharmaceutical and biotech companies, understanding the requirements and implications of CDISC standards is essential for successful drug development and regulatory approval.

The FDA’s Stance on CDISC Standards

The FDA has been working closely with CDISC since its inception to develop and implement data standards that facilitate the regulatory review process. As a result, CDISC standards have become mandatory for all clinical studies submitted to the FDA since December 2016. This requirement underscores the importance of CDISC standards in the pharmaceutical industry and their role in expediting the drug approval process.

Key CDISC Standards Required by the FDA

Since December 17, 2016, the FDA has required the use of CDISC standards for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) involving studies initiated after December 17, 2014. This requirement is outlined in the FDA’s Study Data Standards Resources, which include:

• Study Data Technical Conformance Guide (TCG) – A resource that provides technical recommendations for preparing and submitting standardized study data to the FDA
• Data Standards Catalog – A resource that specifies which versions of data standards and terminologies are supported by the FDA for use in regulatory submissions

The FDA specifically requires the following CDISC standards for regulatory submissions:

• Study Data Tabulation Model (SDTM) – A standard for clinical data in tabular form, designed to facilitate data aggregation and sharing 
• Analysis Data Model (ADaM) – A standard for analysis-ready datasets derived from SDTM 
• CDASH (Clinical Data Acquisition Standards Harmonization) – A standard for the capture of clinical data, optimized for ease of collection, data quality, and subsequent transformation into SDTM format
• SEND (Standard for Exchange of Nonclinical Data) – A standard for preclinical data, such as toxicology studies in animals

These standards ensure clinical trial data is presented in a consistent, understandable format, allowing FDA reviewers to process and analyze the information more efficiently.

Benefits of CDISC Standards in Clinical Research

The implementation of CDISC standards offers numerous advantages to the pharmaceutical and biotech industries:

• Increased efficiency

By standardizing data collection and reporting methods, CDISC standards significantly reduce the time and resources required to prepare regulatory submissions. This efficiency can lead to faster drug development timelines and potentially quicker market access for new treatments. FDA reviewers are trained to work with CDISC-compliant data, which accelerates the review process. Submitting data in a standardized format reduces the risk of additional queries, saving time for both sponsors and regulators.

• Enhanced data quality

CDISC standards ensure uniformity in data collection and reporting, reducing the likelihood of errors and inconsistencies. For instance, SDTM provides a standard structure for organizing data, making it easier for regulatory authorities to evaluate clinical trial outcomes. This improvement in data quality can lead to more accurate analyses and more reliable results, ultimately benefiting both researchers and patients.

• Facilitated data sharing

CDISC standards promote interoperability, making it easier to compare data across clinical trials, both within an organization and externally. This capability is particularly valuable for collaborative research efforts and meta-analyses. Many regulatory agencies worldwide, including the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), also endorse CDISC standards. Compliance with CDISC enables seamless submissions across international markets.

Implementing CDISC Standards: Challenges and Solutions

Adopting CDISC standards can present challenges for organizations, particularly those with established data management processes: 

• High initial costs

Adopting CDISC standards often requires significant investment in training, software, and data conversion. Smaller organizations may struggle to allocate the necessary resources.

• Complexity of data transformation

Converting legacy data into a CDISC-compliant format can be time-consuming and complex. This process requires specialized expertise and a thorough understanding of regulatory requirements.

• Keeping up with updates

The CDISC standards are continuously evolving to meet new regulatory demands and industry trends. Staying updated can be challenging for organizations without dedicated resources for regulatory compliance.

However, several strategies can help with overcoming these hurdles:

• Early planning

Incorporating CDISC standards from the outset of a clinical trial can prevent costly and time-consuming data conversions later in the process. This approach requires careful planning and collaboration among clinical, data management, and statistical teams.

• Leveraging technology

Utilizing specialized software tools and platforms can significantly streamline the implementation of CDISC standards. These tools can automate many aspects of data standardization, reducing the potential for human error and increasing efficiency.

• Continuous training

Ensuring all team members are well versed in CDISC standards is crucial for successful implementation. Regular training sessions and workshops can keep staff up to date with the latest standards and best practices.

• Collaboration with experts

Partnering with organizations that specialize in bioinformatics services and CDISC implementation can provide valuable expertise and support throughout the clinical trial process.

The Future of CDISC Standards and FDA Requirements

As the field of clinical research continues to evolve, especially with the potentially transformational role of AI in drug development, CDISC standards are likely to adapt and expand. The FDA has demonstrated an ongoing commitment to data standardization, as evidenced by its Data Standards Strategy for fiscal years 2023–2027. This strategy emphasizes the continued importance of CDISC standards in regulatory submissions and highlights areas for future development.

Some potential areas of growth for CDISC standards include:

• Integration with real-world data sources
• Adaptation to emerging therapeutic areas, such as gene and cell therapies
• Enhanced support for patient-reported outcomes and wearable device data

As these standards evolve, pharmaceutical and biotech companies must remain vigilant and adaptable to ensure continued compliance with FDA requirements.

CDISC standards aren’t just a regulatory requirement—they represent a fundamental shift in how clinical research data is collected, analyzed, and submitted. They enable seamless integration with cutting-edge tools, enhancing predictive modeling, clinical trial optimization, and real-time decision-making. For companies in the pharmaceutical and biotech sectors, embracing CDISC isn’t just about regulatory compliance—it’s a strategic advantage in a competitive landscape.

As the world of clinical research continues to evolve, staying informed about CDISC standards and FDA requirements will be crucial for success in drug development and regulatory approval. By investing in the necessary tools, expertise, and training, organizations can position themselves at the forefront of clinical research innovation and efficiency.

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