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Requesting New Domains or Variables

Source: vignettes/add_new_domain_var.Rmd
add_new_domain_var.Rmd

Step-by-Step Instructions for Submitting a Request

This guide provides detailed instructions for users on how to submit requests for adding new domains or variables to gsm.mapping.

1. Navigate to the GitHub Issues Page

  1. Visit the repository’s GitHub page.
  2. Click on the Issues tab located at the top of the repository page and click the green New Issue button.
  3. Or click here

2. Open a New Issue

  1. Select the template labeled “Request New Domain or Variable”.

3. Complete the Request Template

Provide detailed and clear information to ensure the request can be addressed efficiently. Use the following structure:

A. Request Title

  • Use the format: Request for New Domain/Variable: [Domain Name or Variable Name]

B. Details Section

Complete the following fields:

  1. Domain Name (if applicable):
    • Provide the name of the domain (e.g., AE for Adverse Events, LB for Laboratory Tests).
    • If this domain has dependencies on other domains, please specify them. (e.g. the COUNTRY domain depends on SUBJ domain.) This will help aid the priority/order in which the workflow is run.
  2. Variable Name(s):
    • List the variable(s) you need added (e.g., AESEV for Adverse Event Severity).
    • If this variable has an original source, provide the name of the source column.
  3. Variable Metadata:
    • Provide detailed metadata for each variable, including:
      • Expected Data Type (e.g., Character, Numeric, Date)
  4. Rationale for Addition:
    • Explain why this domain or variable is important for your monitoring needs. Include specific use cases if possible.
  5. Example Data:
    • Provide example data or mock-up rows illustrating how the domain or variable should look in the pseudo-SDTM format.
  6. References (if any):
    • Include any references to regulatory guidance, protocol requirements, or study documentation supporting this request.

C. Additional Context (Optional)

  • Add any additional context, such as:
    • Link to related issues or discussions.
    • Challenges you are facing without this domain or variable.

4. Submit the Issue

  1. Review your request for completeness and accuracy.
  2. Click the Submit new issue button.

5. Follow Up on the Request

  • Monitor your issue for updates or comments from the maintainers.
  • Respond promptly to any questions or requests for clarification.
  • Collaborate with the team as needed to finalize the implementation.