In today’s global research landscape, clear and consistent communication is more than a necessity — it’s a strategic advantage. It is particularly critical in clinical trials, where data must speak a universal language across teams, geographies, and regulatory frameworks.

The CDISC (Clinical Data Interchange Standards Consortium) and CRF (Case Report Form) standards serve as the universal language of clinical trials, ensuring consistency, clarity, and collaboration across the entire study lifecycle. By implementing these essential frameworks, organizations can optimize data collection, management, and submission — driving cost efficiency and accelerating medical advancements.

Here, we discuss CDISC and CRF standards and how they support the design, execution, and analysis of clinical trials.

The need for standardization

Overall, ensuring consistent and reliable data across multiple clinical studies requires the standardization of processes, procedures, and data collection methods. This uniformity can improve data quality, facilitate data sharing and analysis, and ultimately enhance the efficiency and validity of clinical research.

There are many benefits to utilizing CDISC and CRF standards, such as:

• Improved data quality and reliability
• Enhanced data sharing and integration
• Increase efficiency
• Improved communication and collaboration
• Support for regulatory compliance
• Scalability and repeatability

Let’s take a closer look at how CDISC and CDASH standards help create a foundation for data collection, presentation, and submission in clinical trials.

CDISC Foundational Standards

CDISC (Clinical Data Interchange Standards Consortium), a global non-profit organization, develops and promotes standards for data exchange in clinical research. The CDISC Foundational Standards support end-to-end clinical and non-clinical research processes, focusing on the core principles for defining data standards, and include models, domains, and specifications for data representation.

FDA guidance on CDISC standards

In recent years, the FDA has clearly stated its preference for receiving both clinical and analysis data formatted in compliance with CDISC standards. This has been communicated through a series of guidance documents, correspondence with sponsors, and presentations at conferences. As a result, CDISC models have become the de facto standard for submitting data to the FDA.

As of today, the FDA requires the following CDISC standards:

• Controlled terminology
• SEND
• SDTM
• ADaM
• Define-XML

CDASH: Maximizing data quality

CDASH (Clinical Data Acquisition Standards Harmonization), a foundational standard developed by CDISC, focuses on harmonizing data collection in clinical trials, providing guidance on how to design and populate case report forms (CRFs) to ensure consistent data collection across studies. These standards help maximize data quality in order to streamline processes across the entire spectrum of medical research, from crafting clinical research protocols to reporting and regulatory submissions.

 CDASH Model v1.3 — the latest version — was released in September 2023.

Key features of CDASH

• Provides guidance on designing and populating CRFs/eCRFs, covering all therapeutic areas and phases of clinical trials
• Specifies standard field names, meanings, and how to fill them
• Characterizes fields as highly recommended, conditional, or optional
• Includes a CDASH Model and CDASH Implementation Guide

The benefits of CDASH

Instead of following bespoke standards, CDASH’s guidelines for CRFs/eCRFs help sponsors collect data consistently across studies. This further aids in producing data in SDTM format for submission purposes and allows regulators to review data submission packages more accurately and efficiently, identifying concerns or making approvals faster. In addition, you can remove the duplication of trials and post-marketing evaluation, improving patient centricity.

CDASH standards also provide guidance for the development of data collection tools, which are clear, understandable, and precise. Following CDASH standards ensures traceability of trial data from the time the data is collected at the site until the data is ready for final analysis and regulatory submission. This maintains the integrity of source data to support the trial’s outcome/findings.

Sponsors can further save on time required for setting up new studies following the CDASH standards as most of the data collection and associated programming can be standardized across studies.

CRF libraries

A Case Report Form (CRF) library in clinical trials is a collection of standardized, reusable CRFs designed to streamline data collection and management. These libraries, whether electronic or physical, offer templates and guidelines for collecting data across different trials and therapeutic areas. They ensure uniformity, accuracy, and efficiency in data collection, ultimately benefiting trial conduct and analysis.

CRF libraries can reduce the cost and time budgeted for the clinical trial database preparation by:

• Streamlining processes
• Reducing training
• Accelerating clinical trials
• Using resources more efficiently
• Improving adaptability and consistency
• Focusing on design

Final Takeaways

CDISC standards, including CDASH and CRF standards, have revolutionized the way clinical data is managed, presented, and submitted, enhancing its integrity and efficiency in clinical research and drug development. Conformance to these standards is thus a critical aspect of clinical studies to ensure uniform data collection and submission processes, ultimately bringing quality treatments to patients faster.

Interested in learning more?

Watch our on-demand webinar, “Boosting Efficiency with CRF and CDISC Standards”:

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