CDISC SEND Controlled Terminology Best Practices

Are “Not Done” and “NOT DONE” the same? Not in CDISC SEND controlled terminology.

The correct use of controlled terminology is a critical part of submitting study data to the FDA. It can be challenging, though.

A PDF of the current CDISC SEND controlled terminology has several pages. It includes thousands of terms and values.

Following best practices can help you follow the terminology standard. Learn more about CDISC SEND-controlled terminology and how best to implement it.

What Is CDISC SEND Controlled Terminology?

CDISC SEND-controlled terminology is the set of standard expressions or values used with data items in a nonclinical dataset for submission to the US Food and Drug Administration (FDA).CDISC (Clinical Data Interchange Standards Consortium) is a non-profit organization that develops and supports global data standards. The goal of these standards is to improve the quality and interoperability of medical research.

CDISC partners with the National Cancer Institute Enterprise Vocabulary Services (NCI EVS) to develop and support controlled terminology. EVS distributes controlled terminology through the NCI Thesaurus. Study submissions to FDA must follow CDISC standards, including CDISC SEND controlled terminology. Study data submitted to the FDA must follow a CDISC Study Data Tabulation Model (SDTM). The Standard for Exchange of Nonclinical Data (SEND) is the version of SDTM for nonclinical studies.

What Does CDISC Controlled Terminology Include?

CDISC-controlled terminology is a set of code lists and valid values. It defines key concepts that are represented as:

Definitions
Submission values
Synonyms
Code lists
Codes
Code system elements

These values are for use within CDISC-defined datasets for submission to FDA and PMDA. Controlled terminology does not tell you what data to collect. It tells you how you should format the data you collected. It is important throughout the clinical research lifecycle.

CDISC and EVS regularly update the controlled terminology files. They accept requests for additions or changes to the terminology through the NCI EVS website.

Importance of Compliance with CDISC SEND Controlled Terminology

Proper use of controlled terminology is an important part of compliance with CDISC SEND. The FDA can refuse to file applications whose study data do not conform to the required standards.

CDISC SEND standardizes the organization, format, and structure of nonclinical data. It makes the data consistent across studies and sponsors.

Compliance with CDISC SEND makes the study review process more efficient. It helps improve the quality of the scientific review. A more efficient process can decrease the timeline and cost of drug development.

Controlled terminology facilitates data exchange and interpretation. It makes integrated analysis stratified by study possible. It also makes cross-study comparative analysis easier. This can help improve patient safety and outcomes. It can provide valuable information for regulatory decisions.

Controlled Terminology in the CDISC SEND Process

SEND data with controlled terminology makes up one module in a complete electronic Common Technical Document (eCTD). Submissions to CDER and CBER must be in eCTD format.

SEND data using controlled terminology is a requirement for submissions to CDER for:

NDA, BLA, and ANDA studies that started on or after December 17, 2016
IND studies that started on or after December 17, 2017

The rule comes into effect for submissions to CBER for studies that start on or after March 15, 2023.

eCTD Format

A complete eCTD has five modules. The first includes regional administrative information. The second module is an overview of the manufacturing information and study reports that make up the final three sections. The third module describes manufacturing information. The fourth module covers nonclinical study reports. This is the section that includes CDISC SEND-controlled terminology.

Clinical study reports make up the final module of the eCTD.

Controlled Terminology Best Practices

Proper use of controlled terminology is critical for the FDA submission process.

Errors can occur because of many factors including:

Data entry mistakes
Typos, misspellings, and casing errors
Unfamiliarity with the system

Following best practices helps ensure your terminology is correct.

Use the Right Version of Terminology

New versions of controlled terminology may be released quarterly. The version you should use depends on several factors.

New and Ongoing Studies
For innovative studies, FDA requires that sponsors use the most recent version of the dictionary that was available when the study started.

Sometimes a latest version becomes available during a study. Sponsors may choose to use the most current version for that study.

An application may have different versions of controlled terminology for different studies. In this case, it should explain the impact (if any) on the study results.

Pooled Studies
A pooled analysis should use a single version of the terminology. This holds even if individual studies use different ones. The version for the pooled analysis should be the most current when the data are pooled. An explanation of the terminologies and versions used in the study should appear in the relevant reviewer guide.

Proofread Terminology Carefully

Errors while entering data can result in conformance issues. They make using and developing automated review and analysis tools more difficult for reviewers. Common problems include:

Misspellings
Non-conforming use of upper-and lower-case letters
Non-conforming use of hyphens

Proofreading carefully helps avoid some of these issues. All controlled terminology must match the exactspelling, case, and hyphenation in the dictionary.

Avoid Synonyms

CDISC SEND-controlled terminology includes a column of synonyms. However, these terms are not for use in the dataset. CDISC provides synonyms to facilitate mapping between sponsor terminologies and controlled terminologies.

For example, studies with many types of lab tests have many different units in their results. If units from the lab work are not in the Submission Values column, look for a mathematically synonymous unit. Always use values from the CDISC Submission Values column, not the synonyms column.

Use Extensible Code Lists Appropriately

Apply standard controlled terminology wherever possible. The option of using non-standard terminology exists for extensible code lists. You can add new terms if they are not duplicates, synonyms, or subsets of existing values.

First, check carefully to be sure a synonym does not exist. You can look at the synonym’s column and in the denied requests file.

Denied requests tell you if someone else has requested the term. If CDISC denied the request, you can see why. You can also gain insight into how to map the term you need into the standard. If a synonym is not available, you can submit a request for a new term. This should happen as soon as possible. Otherwise, you may not have a response before you want to submit your package to FDA.

Avoid Mapping to "OTHER"

FDA does not recommend mapping a collected value to “OTHER.” If a controlled term is available to match the collected value, you should use it. Search synonyms and denied requests to verify that an appropriate term does not exist.

Any –TERM field mapped to a –DECODE value of “OTHER” needs a clear explanation in the reviewer’s guide.

Ensure that Data Collection Is Controlled and Consistent

Using CDISC SEND-controlled terminology is easier when you plan it into the data collection process. When you format data with the proper terminology from the beginning, you avoid the difficulties of converting it later. You avoid errors that can occur during conversion.

FDA allows the use of multiple versions of controlled terminology in the same application. Ensuring that each study uses one version consistently makes compliance easier, though. Consistency is especially important for extensible terminology. These non-standard terms should be the same within each study and throughout the complete submission.

Other Relevant Terminology Standards

Controlled vocabularies in addition to CDISC SEND are relevant to nonclinical studies. They may be part of your SEND datasets. Following the applicable terminology, and standards help ensure the quality of your FDA application.

FDA UNII
The FDA Unique Ingredient Identifier (UNII) identifies active ingredients administered to study subjects. UNIIs are necessary for all active moieties of investigational products. They are also necessary for background treatments specified in the protocol.

You can find UNII codes in the FDA Substance Registration System. The National Library of Medicine hosts this system.

NDF-RT
The Veterans Administration maintains the National Drug File -Reference Terminology (NDF-RT). This terminology identifies the pharmacologic class of active investigational substances in a study. FDA maintains a list of established pharmacologic classes for approved active moieties.

Following CDISC SEND Controlled Terminology Best Practices

Proper use of CDISC SEND-controlled terminology is critical for successful applications to FDA. Ensuring that your SEND data is formatted correctly can be a challenge, though. Even small errors like incorrect capitalization can result in nonconformity. Manually converting and ensuring data follows the CDISC SEND standard is labor-intensive and time-consuming.

The right tools and assistance make compliance easier. Xybion offers a SEND intelligence service that packages your nonclinical study data into the required standardized electronic dataset. Our solution can manage data from a variety of sources using different terminologies.

Xybion combines the power of machine learning and subject matter experts. Our professionals use a validated environment when producing your SEND dataset. You can rely on the quality of the results.

Book a consultation today to see how intelligent automation can improve your study submission process.

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CDISC SEND Controlled Terminology Best Practices

What Is CDISC SEND Controlled Terminology?

What Does CDISC Controlled Terminology Include?

Importance of Compliance with CDISC SEND Controlled Terminology

Controlled Terminology in the CDISC SEND Process

eCTD Format

Controlled Terminology Best Practices

Use the Right Version of Terminology

Proofread Terminology Carefully

Avoid Synonyms

Use Extensible Code Lists Appropriately

Avoid Mapping to "OTHER"

Ensure that Data Collection Is Controlled and Consistent

Other Relevant Terminology Standards

Following CDISC SEND Controlled Terminology Best Practices

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