Biometrics clinical research organizations (CROs) are companies specialized in statistical programming and data management services for clinical trial sponsors.
These CROs help biotech and pharma companies to manage clinical data throughout the course of a clinical study, from the initial specification of the electronic data capture (EDC) system to the final statistical analysis of the data required for the publication of results.
When managing clinical trial data, commercial sponsors should consider the importance of CDISC standards.
CDISC stands for Clinical Data Interchange Standards Consortium, which is a set of international standards developed to collect, analyze, and submit clinical datasets in a normalized, well-structured manner.
In the United States of America, the Food and Drug Administration (FDA) requires the submission of datasets using CDISC; in China, CDISC standards are now the preferred standards for electronic data submission. European and South Korean authorities are considering adopting these standards as well.
SDTM (Study Data Tabulation Model) is an important CDISC standard.
What Kind of FDA Submissions Require SDTM?
Ensuring that clinical trial data is SDTM compliant is one of the most relevant requirements for a clinical trial that will be submitted to the FDA.
In fact, the FDA requires the implementation of 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 beginning, making it more efficient, ensuring high quality data and the success of the study, and preparing datasets in SDTM format for submissions.
In the following lines you can learn more about the SDTM standard and how you can obtain professional services for SDTM implementation.
What Is SDTM?
SDTM stands for Study Data Tabulation Model. It belongs to the CDISC standard family.
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.” 
Simply put, SDTM provides templates for structuring the raw data collected during a clinical trial.
In July 2004, the SDTM standard became part of the FDA Study Data Specification referenced in the electronic Common Technical Document (eCTD) Guidance.
Benefits of Using SDTM in a Clinical Trial
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 evident benefit 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 rates.
- Elimination of the need to create and learn organization-specific dataset formats.
- Support for regulatory reviewers to better understand your submission.
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.
SDTM is a standard that the FDA and many actors in the clinical research industry are adopting because it provides a uniform strategy from one study to another to ease data exchange internally and across vendors.
Since SDTM specifies standard variable names, controlled terminology values, and data set structures, others (from a statistical programmer, biostatistician to an FDA reviewer) benefit if data sets are in SDTM format.
Data is expected in a specific format and efficiency is substantially increased when working with data in SDTM format.
Implementation of SDTM in Clinical Trials
Implementing SDTM requires highly specialized expertise in CDISC standards, data management, clinical trials, and statistical programming. Many CROs —known as biometrics CROs— are experts in these areas.
Sponsors interested in implementing SDTM should look for these CROs for help with SDTM requirements and implementation.
SDTM can be implemented at various stages of a clinical trial. However, the best practice is to implement it from the beginning of the study, which provides many benefits.
Data can also be converted to SDTM format at the end in preparation for submission to regulatory authorities, but sponsors should be aware that this practice is not recommended as conversions carry inherent risks, such as losing traceability and other inconveniences to the quality of the data and conformity with regulatory requirements.
Even though the initial investment may be more costly, implementing SDTM and other relevant CDISC standards from the outset of the study saves time and resources, 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.
SDTM Services Offered by Biometrics CROs
The SDTM services that CROs provide for clinical trials include:
Data Management Planning for SDTM
If you know 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 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 hardest programming tasks in a clinical trial.
SDTM mapping requires extensive knowledge and skills, and it is assumed that mapping is challenging for the staff without in-depth knowledge of CDISC standards and datasets.
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 the variables come from in the submitted SDTM datasets.
Complete CDISC-compliant, Submission-ready Data Package
SDTM works in agreement with other CDISC standards required by the FDA, including the fact that it is easier to create analysis data sets, Controlled Terminology, and Define.xml. according to ADaM (Analysis Data Model).
The ADaM model defines dataset and metadata parameters for facilitating the seamless generation, replication, and evaluation of clinical trial statistical investigations. ADaM v0.7 was first created in 2005 by reviewers proficient in clinical studies and regulatory submissions.
SDTM is also coordinated with the CDISC standard CDASH (Clinical Data Acquisition Standards Harmonization), used in the collection of data within the context of electronic CRFs (eCRFs) or electronic data capture (EDC) systems.
CDASH establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into SDTM, delivering more transparency to regulators and reviewers.
As the CDASH standards are a subset of SDTM, their use from the beginning of the eCRF specification optimizes the entire data path, and no redundancy of data collection takes place during the clinical trial.
The CDISC consortium started to work on CDASH standards in October 2006. The teams consisted of clinical data managers, statisticians, medical monitors, and programmers, and they collected data from clinical trial sites with the help of groups like the Society of Clinical Data Management, the National Cancer Institute, Association of CROs, and FDA, among others.
Data standardization allows for interoperability of data between analytical tools and organizations.
Many benefits can be obtained if clinical trial sponsors adapt to data standards, particularly CDISC standards.
CDISC standards were developed to enable the pharmaceutical industry to standardize the clinical trial data collection, analysis, and submission process.
SDTM is a fundamental CDISC standard that should be used in commercial clinical trials with data to be submitted to the FDA and other regulators.
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 in a broad range of therapeutic areas.