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:
The rule comes into effect for submissions to CBER for studies that start on or after March 15, 2023.
Proper use of controlled terminology is critical for the FDA submission process.
Errors can occur because of many factors including:
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.
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.
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.