How to Read a Domain Specification

🌟 Hey, friends! 🌟

Welcome to this week’s episode of Dr. Clinidata! I hope your week was epic! 🚀

Ever found yourself scratching your head over domain specification tables? Well, you're not alone. Let's break it down in a way that won't make your eyes glaze over.

Picture this: You're staring at a table filled with rows and columns, each holding the key to understanding your domain's variables. It's like a treasure map, but instead of X marking the spot, we've got variable names and labels. Let's dive in!

1. Variable Name

• Variable names are like nicknames for your data points. Some are straightforward, lifted right from the SDTM.

• Others play dress-up, replacing "--" with a fancy two-character domain code. It's like giving your variables a makeover!

2. Variable Labels: More Than Meets the Eye

• Think of labels as the variable's formal introduction at a data party. Sometimes they stick to the SDTM script, other times they get creative.

• Pro tip: If you're bringing your own variables to the party, give them a snazzy label that fits right in.

3. Type Casting: Num or Char?

• It's not a personality test, but it's close. Variables are either "Num" (number-crunchers) or "Char" (the chatty ones).

4. Controlled Terms, Codelist, or Format

• Controlled Terms: Look out for the asterisk (*) – it's like a "choose your own adventure" for terminology.

• Codelists: Hyperlinked names in parentheses are your ticket to the CDISC Controlled Terminology Club.

• Formats: When you see "ISO 8601," think of it as the universal language of dates and times.

5. Role

• Each variable has a job to do, straight from the SDTM playbook. But remember, some roles don't make the cut in SDTMIG domain specs – they're like the understudies of the data world.

6. CDISC Notes: The Director's Cut

• This is where you get the inside scoop on your variables:

  1. What they really mean (beyond the label)

  2. How they mingle with other variables

  3. The rules of the game (when and how to use them)

  4. Example values (but don't take these as gospel – always check the official CDISC-Controlled Terminology)

7. Core

• Variables come in three flavors:

  1. "Req" (Required): The non-negotiables

  2. "Exp" (Expected): The "should haves"

  3. "Perm" (Permissible): The "nice to haves"

Remember, this table isn't just a list – it's a living, breathing guide to your domain's data ecosystem. It's designed to help you navigate the complex world of clinical data standardization with a bit more ease and maybe even a smile.

So, the next time you're faced with a domain specification table, don't sweat it! Think of it as your data's personal resume, complete with names, labels, and roles. It's all about making sense of the information jungle and turning it into a well-organized garden of knowledge.

And hey, if you ever feel lost in the terminology wilderness, just remember that behind every variable is a story waiting to be told. Your job is to be the storyteller, using this table as your trusted guidebook.

Happy data wrangling, folks! May your variables be well-defined, your codelists clear, and your data always tell the true story of your clinical trials.

1. SDTM-Implementation Guideline (SDTMIG) - CDISC 

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