The SDTMIG Disposition Events Public Review Details:
The following Disposition (DS) domain proposals pertain to: 1) Multiple Disposition Events, per EPOCH and 2) Multiple Informed Consents. This information has been collated for the public as an opportunity to review and comment on the two proposals, which are intended to be included as part of the next release of SDTMIG, v3.3. Both proposals loosen existing restrictions. Below are links to each respective proposal, which will provide: a summary, examples and revisions to each applicable DS assumption.
- Instructions for Reviewers — Detailed instructions for how to use JIRA to provide feedback on Disposition Events are below.
Content for review:
Instructions for Reviewers
Reviewers are requested to make any necessary text revisions directly in the Wiki and provide comments via JIRA. Wiki and JIRA use the same credentials, so if you can see this page, then you can use JIRA.
If you have no comments on a page:
- Click 'Like' at the bottom of the page. This will help us determine who has read each page.
To add comments from within JIRA:
- Go to the SDS project in JIRA at: https://jira.cdisc.org/projects/SDS/issues/
Keeping JIRA open in a separate window to capture comments is easier than navigating back and forth between the Wiki and JIRA.
- Click on the "Create" button in the top menu to bring up the Create Issue form.
- Make sure the issue type is set to "Review Comments"
- Fill out the form.
- Choose Disposition Events from the list in the "Component(s)" field.
- Provide a short summary or the gist of your comment in the "Summary" field.
- Enter your comment, and any additional, details in the "Description". To help the team address your comment properly, be thorough.
- Click the "Create" button in the bottom right corner of the form to submit.
Next to the "Create" button is an option to "Create another". If this is checked, clicking "Create" will submit your comment and bring up a new Create Issue form with the same project and review type. This can be handy if you have multiple comments to enter.
Instructions for creating an issue can be found here: https://confluence.atlassian.com/display/JIRA/Creating+an+Issue
To link an existing JIRA issue to a page:
- Find the issue in JIRA. Make sure you are viewing the issue itself (as opposed to viewing its details from within a search or filter) by right-clicking on the issue key and opening it in a new tab or window.
- Copy the URL for the issue.
- Go to the page you want to add the issue to.
If the content to which you wish to add the issue is in mirrored from another page via an Include Page macro, you can find the source page by clicking on the macro in edit mode and choosing "Go to Included Page".
This will open the page in a new tab/window, so be sure to close out of edit mode on the original tab.
Enter edit mode.
- Find where on the page you want to add the issue.
- Paste the URL.
- The Wiki should recognize the URL as a link to a JIRA issue and transform it into a JIRA macro.
- Save the page.
To add comments to JIRA from within the Wiki:
- Select the text to which you wish to attach the comment. After a moment, a small contextual menu should appear.
If the text you have selected is not unique on the page, or contains any links or images, the JIRA Connector will be unable to find right place to automatically insert the issue upon creation. In most cases, five words of plain text should be enough to ensure a unique text string, but this is not guaranteed.
Depending on your browser, the JIRA Connector may also experience difficulties if the content to which you wish to add the issue is mirrored from another page. Reviewers are recommended to enter comments on the content's source page whenever feasible.
- Within the contextual menu, click on the icon that looks like an X. This will trigger an abbreviated Create Issue form.
If you get a notice that "Atlassian JIRA needs your permission to connect to Confluence" instead, click on "Allow", and then "Allow" again. When you are returned to the page in the Wiki, the Create Issue form should be open.
- Check to make sure the project selected (the first part of the first line under the title of the form) is "SDS", and the issue type (the second part) is "Review Comments".
- It it isn't, click on "Edit" on the same line to convert the line into two drop-down menus.
- Choose "SDS" from the first drop-down menu.
- Choose "Review Comments" from the second drop-down menu.
- Fill out the form and click the "Create" button in the bottom left corner of the form to submit your comment as an issue.
In case of technical difficulties, please make sure to provide a brief description of the context of your comment, so the team can address it properly.
- The page should automatically update with your comment inserted in place.
If you get a notice that the issue "has been created, but there is a problem in adding it to the page," you can click on the key in the notice to open the issue just created in JIRA, and then insert it into the page manually.
Instructions for creating an issue from within Confluence (the Wiki) can be found here: https://confluence.atlassian.com/doc/use-jira-applications-and-confluence-together.html
How to edit a page:
- Select 'Edit' in the top right corner of the page to enter edit mode.
The wiki allows simultaneous editing, but may have difficulty resolving changes made to the same section made by more than one person at the same time. A notice is displayed across the top of the page (in edit mode) if it is currently undergoing revision by someone else. If such a notice appears, you may wish to wait on making your edits until the other person has finished.
To minimize the potential inconvenience to others, please keep the time spent in edit mode of a page to a minimum.
- Add the JIRA issue that describes your comment.
- Select 'Save' in the bottom right corner of the page.
Instructions for editing an page can be found here: https://confluence.atlassian.com/doc/the-editor.html