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Requirements for data submission are defined and managed by the regulatory authorities to whom data are submitted. This section describes general requirements for datasets which may be part of a submission. However, additional conventions may be defined by regulatory bodies or negotiated with regulatory reviewers. In such cases, additional requirements must be followed.

Tabulation Datasets

Observations about tobacco products and study subjects generated to support a submission are represented in a series of datasets aligned with logical groupings of data per domains. Domains described in this guide are generally aligned with implementation of a single dataset in which to represent data in scope for a domain. All datasets are structured as flat files with rows representing observations and columns representing variables. In some cases, a dataset implemented for a domain may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. 

The following guidance will be adhered to when implementing tabulation datasets: 


NumGuidance ForImplementation
1Dataset Content

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

  • Data as originally collected or received to support the submission.
  • Data from external references relevant to the submission (such as a study protocol).
  • Data assigned per conventions in the TIG.
  • Data derived per regulatory and TIG conventions.
2Dataset Naming

Each domain dataset is distinguished by a unique, 2-character code that will be used consistently throughout the submission.

Dataset names will reflect the following conventions:

  • Names will be a unique 2 to 4 letter character code.
  • This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).

This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).

3Variable Naming
4Splitting Datasets

A domain dataset may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. The following conventions must be adhered to when splitting domains into separate datasets:

  • A domain based on a General Observation Class may be split according to values in variable --CAT. When a domain is split on --CAT, --CAT must not be null.
  • The Findings About (FA) domain may be split based on the of the value in variable --OBJ.

To ensure split datasets can be appended back into one domain dataset:

    1. The value of DOMAIN must be consistent across the separate datasets as it would have been if they had not been split (e.g., LB, FA).
    2. All variables that require a domain prefix (e.g., --TESTCD, --LOC) must use the value of DOMAIN as the prefix value (e.g., LB, FA).
    3. --SEQ must be unique within USUBJID for all records across all the split datasets. If there are 1000 records for a USUBJID across the separate datasets, all 1000 records need unique values for --SEQ.
    4. When relationship datasets (e.g., SUPPxx, FAxx, CO, RELREC) relate back to split parent domains, the value of IDVAR would generally be --SEQ. When IDVAR is a value other than --SEQ (e.g., --GRPID, --REFID, --SPID), care should be used to ensure that the parent records across the split datasets have unique values for the variable specified in IDVAR, so that related children records do not accidentally join back to incorrect parent records.
    5. Permissible variables included in one split dataset need not be included in all split datasets.
    6. For domains with 2-letter domain codes, split dataset names can be up to 4 characters in length. For example, if splitting by --CAT, dataset names would be the domain name plus up to 2 additional characters (e.g., LBHM for LB if the value of --CAT is HEMATOLOGY). If splitting Findings About by parent domain, then the dataset name would be the domain code, "FA", plus the 2-character domain code for parent domain code (e.g., "FACM"). The 4-character dataset-name limitation allows the use of a Supplemental Qualifier dataset associated with the split dataset.
    7. Supplemental Qualifier datasets for split domains would also be split. The nomenclature would include the additional 1 to 2 characters used to identify the split dataset (e.g., SUPPQS36, SUPPFACM). The value of RDOMAIN in the SUPP-- datasets would be the 2-character domain code (e.g., QS, FA).
    8. In RELREC, if a dataset-level relationship is defined for a split Findings About domain, then RDOMAIN may contain the 4-character dataset name, rather than the domain name "FA", as shown in the following example. 

      relrec.xpt

      Row

      STUDYID

      RDOMAIN

      USUBJID

      IDVAR

      IDVARVAL

      RELTYPE

      RELID

      1ABCCM
      		CMSPID
      		ONE1
      2ABCFACM
      		FASPID
      		MANY1

Analysis Datasets

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