Ensuring that clinical trial data is SDTM compliant is one of the most significant aspects for a clinical trial that will be submitted to the United States Food and Drug Administration (FDA). The FDA requires SDTM for the following submissions to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER):
- Commercial Investigational New Drug (IND) applications (products to be commercially distributed).
- New Drug Applications (NDAs).
- Abbreviated New Drug Applications (ANDAs).
- Biologics License Applications (BLAs).
- All subsequent submissions to these applications, including amendments, supplements, and reports.
SDTM services can help sponsors in designing their trial from the outset, making it more efficient, ensuring high quality data and the success of the trial, or converting data to SDTM in preparation for submission. Find out more about SDTM and SDTM services below.
What Is SDTM?
SDTM stands for Study Data Tabulation Model. It is a standard of CDISC, the Clinical Data Interchange Standards Consortium.
As CDISC explains on its website, “SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing, fosters mining and reuse, facilitates sharing, helps perform due diligence and other important data review activities, and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.” [1]
To put it more simply, SDTM provides templates for structuring the raw data collected during a clinical trial.
Are There Benefits to Using SDTM beyond Regulatory Requirements?
SDTM provides a model for presenting clinical trial data in a tabulated standard form. Using it will ensure not only the quality of the data but also its transmission and compliance with regulatory requirements.
Beyond the obvious advantage of meeting regulatory requirements when authorities like the FDA demand it, implementing SDTM has additional advantages, including:
- Easier uniformity across studies.
- Improved data consistency.
- Results in less work per study.
- Reduction of error chances.
- Elimination of the need to create and learn organization-specific dataset formats.
- Support for reviewers to better comprehend your submission.
- Facilitation of data exchanges across different platforms.
- An offer of the experience of a global community to assist you with all questions.
Implementing SDTM from the beginning of a trial, versus converting data to SDTM format at the end in preparation for submission to regulators also has the advantage of ensuring that the collected and tabulated data meet the standards required by regulators.
How Can SDTM Be Implemented in Clinical Trials?
Implementing SDTM requires expertise in CDISC standards, data management, clinical trials, and statistical programming. Many Clinical Research Organizations (CROs), —sometimes known as biometrics CROs— exist with the needed expertise. Sponsors interested in implementing SDTM should seek out such CROs for assistance with SDTM requirements and implementation.
SDTM can be implemented at various stages of a clinical trial. However, the best practice is to integrate it from the beginning of the study, which provides many advantages. Data can also be converted to SDTM format at the end in preparation for submission to regulatory authorities, but sponsors should keep in mind that this is not ideal as conversions carry inherent risks, such as losing traceability and other problems to the quality of the data and conformity with regulatory requirements. This can ultimately put the success of the trial at risk.
Even though the initial investment may be greater, implementing SDTM and other relevant CDISC standards from the outset of the study saves time and money, and results in stronger data and faster approval time in the end.
A CRO with expertise in SDTM can help sponsors select the right strategy and technology for cost-efficient implementation of SDTM.
What SDTM Services Are Provided By CROs?
The SDTM services that CROs provide for clinical trials include:
Data management planning for SDTM
Knowing that clinical trial data will have to be submitted according to SDTM if submitting to the FDA, it is better to plan for it from the beginning of a trial. SDTM services include planning for the implementation of SDTM.
SAS statistical programming for SDTM
The best option for implementing SDTM is to integrate it with all data programming activities. This avoids having to convert or map data from one programming structure to another at a later stage or in preparation for submission.
SDTM mapping
It refers to mapping datasets from a non-CDISC structure to the CDISC SDTM structure. Taking the data from one programming structure to another while preserving data integrity and traceability within the data is one of the most difficult programming tasks in a clinical trial.
SDTM Define.xml files
The FDA requires that a Define.xml file accompany all drug application submissions. This file describes the content and structure of the trial data, making the review of study data quicker and easier for reviewers.
SDTM annotated CRF
When STDM is required by regulators, the Case Report Form (CRF) must also be SDTM compliant. A CRF annotated according to the SDTM data tabulations is a required part of a new drug application. This annotation links the fields on the form with the variables in the datasets to help the reviewer find where variables come from in the submitted SDTM datasets.
Complete CDISC-compliant, submission-ready data package
SDTM works in harmony with other CDISC standards required by the FDA, including the fact that it is easier to create Analysis Data Sets (ADaM), Controlled Terminology, and Define.xml. according to ADaM, the Analysis Data Model. SDTM also coordinates with the CDISC standard CDASH, used in the collection of data within the context of electronic CRFs (eCRFs) and electronic data capture (EDC) systems.
Sofpromed is an expert biometrics CRO specialized in SDTM services. We provide high-quality SDTM support to biotech and pharmaceutical companies conducting phase I-IV clinical trials worldwide.
If you need SDTM services for clinical trials, contact us at info@sofpromed.com
References:
[1] CDISC. “SDTM Description.”
