A Beginner’s Guide to SDTM Specification Management Software

Researchers at Cedars-Sinai Medical Center recently discovered that a combination of enzalutamide and hormone therapy could cut the risk of death from prostate cancer by 40%. The clinical trial focused on patients whose prostate cancer had recurred after radiation therapy or surgery failed to eradicate the disease.

One of the clinical trial’s authors described their findings as a game-changer in the ongoing fight against cancer. Before, neither FDA-approved prostate cancer treatments could deal with the disease alone. (1)

A “game-changing” discovery in medical research (let alone cancer research) shouldn’t be taken lightly. It shows confidence in the results and, more importantly, the data used. Data quality isn’t only about being accurate; it must also be complete, current, and consistent.

Satisfying these qualities requires the proper hardware and software, one of which is SDTM specification management software. Here’s an in-depth look at what it does, how it works, and how to use it to its fullest potential.

Making Clinical Trial Data Readable

Before anything else, it’s essential to have an idea of the acronym that comes before it. A Study Data Tabulation Model (SDTM), which was spearheaded by the Clinical Data Interchange Standards Consortium (CDISC), is a required standard for submitting clinical trial data to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for quality review.

Under the FDA’s Study Data Technical Conformance Guide, the CDISC SDTM consists of multiple domains that help the agency scrutinize the data. The latest version, released in March 2025, states that any submission should, if applicable, contain: (2)

SDTM Code	SDTM Domain	Description
DM	Demographics	Subject’s information, like age, race, and sex
DS	Disposition	Status from recruitment to trial progress
SE	Subject Elements	Progress through screening to follow-up
AE	Adverse Events	Negative reactions to the treatment
LB	Laboratory	All lab tests performed during the clinical trial
TDM	Trial Design Model	Outlines the elements of the clinical trial
EC	Exposure as Collected	Exposure to treatment collected on the eCRF*
DD	Death Details	Information on autopsy following death
QS	Questionnaires	Subject’s answers to questionnaires
SUPPQUAL	Supplemental Qualifier	Any domain not represented by those above

The list is not exhaustive
*Electronic Case Report Form

Each subject is identified with a Subject ID (SUBJID), but they also have a Unique Subject Identifier (USUBJID) to be recognized across datasets. A patient’s SUBJID may vary from study to study, but their USUBJID stays the same across all studies of a specific treatment. Custom domains can be added, provided they follow SDTM implementation guidelines.

Organizing SDTM domains and, later, the datasets shouldn’t be done manually, lest risk the study being questioned for inconsistencies. A compliant SDTM specification management software eases the burden on researchers by automating key steps in data submission. Long story short, you can’t deliver your findings to the authorities without using one.

Software Modules

The features or modules of an SDTM specification management software may vary by provider. As a start, consider searching for one with at least the following:

Autofill and Validation

Data entry can be automated, but not entirely. Given the number of subjects clinical trials deal with, it may be tempting to leave that job to artificial intelligence. However, even a single error in the dataset can alter a trial’s results and invalidate months of research.

That’s why, in addition to autofilling SDTM datasets through Electronic Data Capture (EDC), the software should also make clinical data validation a breeze. This feature compares the existing dataset with SDTM validation rules and flags any issues.

Define.XML Processing

Displaying clinical trial data isn’t as easy as plotting it on a regular spreadsheet. The FDA requires the document to be in an Extensible Markup Language (XML) file, reflecting the data as it appears on an eCRF. This way, you can reduce the likelihood of errors during data entry.

The software takes it a step further by adopting a variant of the XML file, called define.xml. As the term suggests, this format defines the metadata of the clinical data submitted. The software makes this easy by enabling users to use it like a spreadsheet.

Study Reviewer’s Guide Creation

The Study Data Reviewer’s Guide (SDRG) helps reviewers process clinical trial data more efficiently. According to the FDA’s Study Data Technical Conformance Guide, an SDRG for clinical studies is referred to as a cSDRG, whereas one for non-clinical studies is designated as an nSDRG. (2)

Whatever the case, SDTM specification management software comes with templates that apply to both reviewers’ guides. Some can even generate an SDRG with one click based on the study design and study metadata, among other details.

Best Practices

For all its reliability and versatility, the software is only as good as the person using it. And, to an extent, the data it works with. In a study of approximately 100 papers published between 1978 and 2008, error rates in data processing were as high as 2,784 errors per 10,000 fields.

Most of the errors were caused by medical record abstraction or picking details in a health record to be carried over to digital media. The practice isn’t inherently bad, as it can be valuable in transitioning from paper-based to electronic records. The problem is that it requires manually reviewing stacks of records. (3)

As far as the efficient use of the software goes, HIPAA compliance is a no-brainer. Digital records are superior at keeping accurate information, which translates to improved data quality. Along with an EDC system, the software can retrieve the correct data and generate accurate clinical trial outcomes.

Although the software lets you create custom domains, it isn’t something you’d want to rely on too much. Having too many domains risks confusion during trials and the review, especially if they don’t comply with SDTM guidelines. If you can explain your data using as few domains as possible, you should take that opportunity.

Conclusion

Whether the results are important or groundbreaking, clinical research needs a level of data quality only state-of-the-art programs can provide. SDTM specification management software is one of many you’ll need to continue innovating modern medicine.

References

1. “This powerful drug combo cuts prostate cancer deaths by 40%,” Source: https://www.sciencedaily.com/releases/2025/10/251019120507.htm

2. “STUDY DATA TECHNICAL CONFORMANCE GUIDE,” Source: https://www.fda.gov/media/153632/download

3. “Error rates of data processing methods in clinical research: A systematic review and meta-analysis of manuscripts identified through PubMed,” Source: https://www.sciencedirect.com/science/article/abs/pii/S138650562400412X