Standards in Different Regulatory Agencies

Motivation

The xportr package is designed to help clinical programmers create CDISC compliant xpt files. It provides the functionality to associate metadata information to a local R data frame, perform data set level validation checks, and convert into a transport v5 file (xpt). However, technical requirements related to the xpt files can change across different regulatory agencies. This vignette aims to start to provide a clear and concise summary of the differences between the agencies for the xpt files. Further updates will come with later package releases.

The following section will delve into various technical specifications as per FDA, NMPA, and PMDA guidelines.

File name - character

XPT

The first character must be an English letter (A, B, C, . . ., Z) or underscore (_). Subsequent characters can be letters, numeric digits (0, 1, . . ., 9), or underscores. You can use uppercase or lowercase letters. Blanks cannot appear in SAS names. Special characters, except for the underscore, are not allowed.

FDA

Dataset in the transport file should be named the same as the transport file. Variable names, as well as variable and dataset labels should include American Standard Code for Information Interchange (ASCII) text codes only. Dataset names should contain only lowercase letters, numbers, and must start with a letter.

NMPA

The file name and the dataset name must be the same for the SDTM and ADaM datasets. The Japanese dataset and alphanumeric dataset must be identical in structure, except for the data lengths of the Japanese items and the corresponding alphanumeric character sequence

PMDA

Information has not yet been collected.


File name - length

XPT

maximum length of 8 bytes

FDA

8 characters

NMPA

-

PMDA

Information has not yet been collected.


Variable name

XPT

The name can contain letters of the Latin alphabet, numerals, or underscores. The name cannot contain blanks or special characters except for the underscore. The name must begin with a letter of the Latin alphabet (A–Z, a–z) or the underscore.

FDA

Variable names, as well as variable and dataset labels should include American Standard Code for Information Interchange (ASCII) text codes only. Variable names should contain only uppercase letters, numbers, and must start with a letter

NMPA

The Japanese dataset and alphanumeric dataset must be identical in structure, except for the data lengths of the Japanese items and the corresponding alphanumeric character sequence

PMDA

Information has not yet been collected.


Variable length

XPT

8 bytes

FDA

8 characters

NMPA

-

PMDA

Information has not yet been collected.


Label character

XPT

-

FDA

Variable names, as well as variable and dataset labels should include American Standard Code for Information Interchange (ASCII) text codes only. Do not submit study data with the following special characters in variable and dataset labels: 1. Unbalanced apostrophe, e.g., “Parkinson’s” 2. Unbalanced single and double quotation marks 3. Unbalanced parentheses, braces or brackets, e.g.,(, {and [

NMPA

The Japanese dataset and alphanumeric dataset must be identical in structure, except for the data lengths of the Japanese items and the corresponding alphanumeric character sequence

PMDA

For eSubmission in China, one of the requirements is to translate the foreign language data package (e.g., English) to Chinese. Variable labels, dataset labels, MedDRA, WHO Drug terms, primary endpoint-related code lists, etc., need to be translated from English to Chinese.


Label length

XPT

40 bytes

FDA

40 characters

NMPA

-

PMDA

Information has not yet been collected.


Values character

XPT

-

FDA

Variable values are the most broadly compatible with software and operating systems when they are restricted to ASCII text codes (printable values below 128). Use UTF-8 for extending character sets; however, the use of extended mappings is not recommended. Transcoding errors, variable length errors, and lack of software support for multi byte UTF-8 encodings can result in incorrect character display and variable value truncation.

NMPA