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Note

Scope of This Review

A retired example was inadvertently included in SDTMIG v3.4 during the review process. The focus of this Internal Review is on Copy of TD Example 2 Crossover to the Trial Disease Assessments (TD) domain only. Reviewers are requested to give comments only on this example.  All other portions of the SDTMIG have gone thru public review and not included in this material. Any comments outside of TD Example 2 will be considered in the next version of the SDTMIG.


Review Instructions

Reviewers are requested to provide comments via JIRA (Wiki and JIRA use the same credentials, so if you can see this page, then you can use JIRA).

To add comments from within JIRA

  1. Go to the JIRA project associated with this document 

    Keeping JIRA open in a separate window to capture comments is easier than navigating back and forth between the Wiki and JIRA.

  2. Click on the "Create" button in the top menu to bring up the Create Issue form.
  3. Choose the project associated with this document from the Project drop-down menu (i.e., SDS), if it has not already been selected for you. (If a project has already been selected, make sure it's the right one!)
  4. From the Issue Type drop-down menu, set the issue type to "Review Comments", if it is not already.
  5. Choose a Component (e.g., TD Domain) to categorize your comment.
  6. Choose "Internal Review" in the Review Period field.
  7. Fill out the form.
    1. In the Summary field, describe the content to which the comment applies. 
    2. Enter your comment, and any additional details, in the Description field. Please be thorough, so your comment can be addressed properly.
  8. Click the "Create" button in the bottom right corner of the form to submit.

Instructions for creating an issue can be found here: https://confluence.atlassian.com/display/JIRA/Creating+an+Issue

To add comments to JIRA from within the Wiki

  1. Within the applicable section that lists the child page (i.e., pages within SDTMIG domains, SDTMIG specifications, SDTMIG assumptions, SDTMIG examples), navigate to the applicable page, then select the text (ideally, a short, unique phrase) to which you wish to attach the comment. After a moment, a small contextual menu should appear.
  2. Within the contextual menu, click on the The JIRA icon, which is a stylized person with their hands in the air and radiance around their head. Overall, it looks much like an X.JIRA icon. This will trigger an abbreviated Create Issue form. 
  3. Choose the project associated with this document from the Project drop-down menu: "SDS".
  4. Choose "Review Comments" from the Issue Type drop-down menu.
  5. Choose a Component (e.g., TD Domain) to categorize your comment.
  6. Fill out the form. 
    1. The Summary field will be pre-populated with the text that you selected. You can change this or leave it as it is.
    2. Enter your comment, and any additional details, in the Description field. Please be thorough, so your comment can be addressed properly.
    3. In case of technical difficulties, please make sure to include a brief description of the context of your comment.
  7. Click the "Create" button in the bottom left corner of the form to submit your comment as an issue.

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