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1. Establish a common topic or topics for the data. The common topic or topics will reflect a collection of logically related observations based on the scientific subject matter of the data.
   1. If more than one topic is identified, then more than one domain may be needed.
      1. In such cases, consider whether topics are hierarchical in nature where data for one topic must be observed before data for a second topic can be observed. If a hierarchical relationship between topics exists, then a paired domains will be created (an example of an established domain pair is Pharmacokinetics Concentrations (PC) and Pharmakinetics Parameters (PP)). Records in paired domains may then be represented in the Related Records (RELREC) dataset as appropriate.
2. Categorize data within the domain using Grouping Qualifier variables (e.g., --CAT, --SCAT) and identify other qualifiers applicable to the data (e.g., --METHOD, --SPEC) as appropriate.
3. Look for a domain within this guide to serve as a prototype. If no domain seems appropriate, choose the general observation class in the SDTM (Interventions, Events, or Findings) that best fits the data given the topic of the observations.
   1. As illustrated in the following figure, the general approach for selecting variables for a custom domain is:

1. 1. Select and include the required identifier variables (e.g., STUDYID, DOMAIN, USUBJID, --SEQ) and any permissible Identifier variables from the SDTM. 
   2. Include the topic variable from the identified general observation class (e.g., --TESTCD for Findings) in the SDTM. 
   3. Select and include the relevant qualifier variables from the identified general observation class in the SDTM. Variables belonging to other general observation classes must not be added.
   4. Select and include the applicable timing variables in the SDTM.
   5. Determine the domain code, one that is not a domain code in the CDISC Controlled Terminology SDTM Domain Abbreviations codelist (see  https://datascience.cancer.gov/resources/cancer-vocabulary/cdisc-terminology). If it is desired to have this domain code be part of CDISC Controlled Terminology, submit a request at https://ncitermform.nci.nih.gov/ncitermform/?version=cdisc. The sponsor-selected, 2‑character domain code should be used consistently throughout the submission. AD, AX, AP, SQ, and SA may not be used as custom domain codes.
   6. Apply the 2-character domain code to the appropriate variables in the domain. Replace all variable prefixes (shown in the models as “--“) with the domain code.
   7. Set the order of variables consistent with the order defined in the SDTM for the general observation class.
   8. Adjust the labels of the variables only as appropriate to properly convey the meaning in the context of the data being submitted in the newly created domain. Use title case for all labels (title case means to capitalize the first letter of every word except for articles, prepositions, and conjunctions).

   9. Ensure that appropriate standard variables are being properly applied by comparing their use in the custom domain to their use in standard domains.

   10. Describe the dataset within the Define-XML document. See Section 3.2, Using the CDISC Domain Models in Regulatory Submissions — Dataset Metadata.

   11. Place any non-standard (SDTM) variables in a Supplemental Qualifier dataset. Mechanisms for representing additional non-standard qualifier variables not described in the general observation classes and for defining relationships between separate datasets or records are described in Section 8.4, Relating Non-standard Variable Values to a Parent Domain.

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