Versions Compared

Old Version 125

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 126

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Metadataspec
NumGuidance ForImplementation
1Dataset content

Data represented in datasets will include the following per regulatory requirements, scientific needs, and standards in this guide:

  • Data as originally collected or received
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-609
    (using controlled terminology where applicable) to support the submission
  • Data from external references relevant to the submission (e.g., reference data)
  • Data assigned per conventions in the TIG
  • Data derived per regulatory and TIG conventions
2Dataset naming
  • Analysis dataset naming has no predefined values besides for the requirement
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-390
    to have a dataset named ADSL. 
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-610
  • Other ADaM datasets should be named AD + applicant-defined name (ADXXXXXX).
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-611
    The exception to this is the addition of the RF prefix for reference data that has been introduced in the TIG.
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-391
  • There is no rule that noncompliant datasets must start with AX or that they cannot start with AD.
  • ADaM datasets should be named logically, if possible, and consistent naming conventions should be used across studies within a submission. 
3Variable order
  • There is no ordering
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyTOBA-392
    defined for the ADaM standards, although having variables ordered together within a variable group helps review and dataset understanding.
  • Variable order in the ADaM dataset must match the order in the define.xml file.  
4Variable names
  • Variables will be named per ADaM guidance, which uses fragment names in the CDISC NSV Registry.
  • Variable names in TIG ADaM specifications align with naming conventions in ADaM.  
  • Variable names will be 8 characters or less and uppercase. 
5Variable labels
6Variable length

When variable length is referenced in the TIG, this refers to the length in bytes of ASCII character strings.

  • The maximum length of character variable is 200 characters, which should not be used unless necessary.
  • Applicants will consider the nature of the data and apply reasonable, appropriate lengths to variables. For example:
    • The length of flags will always be 1.
    • PARAMCD will never be more than 8, so the length can always be set to 8.
    • The length for variables that use controlled terminology can be set to the length of the longest term.
7Variable value text case

Variable value text case

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-614
generally depends on the variable usage and how it is presented on outputs (but there is no requirement that this convention must be followed
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-394
).

8Missing variable values

Missing values for individual data items will be represented by nulls if necessary for analysis. Otherwise, it is up to the dataset creator whether to include missing values in an analysis dataset. 

9Splitting datasets

An analysis dataset may be split into physically separate datasets to support submission when needed. ADaM currently has no conventions as to the proper way to split analysis datasets, although like types of data should have similar dataset naming.

...