i. Comment Title – The short name of the comment. Provided by Comment Author.
ii. Document Number – A number assigned by CDISC to the document being reviewed.
iii. Document Section – The section of the document that the comment is referring to. Provided by the Comment Author.
iv. Comment – The feedback, suggestion, correction, question or other information that the Comment Author wants the team to know about. Provided by the Comment Author.
v. Comment Category – A classification of the comment used for organizing and managing comments. Provided by the Comment Author but can be updated by the Comment Manager and Team Responder(?).
1. Typo – Use this category if there is a misspelling or other typographical error.
2. Question - Use this category if you have a question about the standard.
3. Major Issue – Use this category if the issue renders the standard unusable and must be resolved before the final publication of the standard.
4. Minor Issue – Use this category if the issue doesn’t render the standard unusable.
5. Suggestion – Use this category if the comment is a recommendation to the team.
vi. CDISC Comment – Relevant working information about the comment for use by the team. Contrast this with the Disposition field. Provided by the Team Responder.
vii. Current State of Comment
1. Open – The comment hasn’t been completely resolved and change hasn’t been made in the document.
2. Resolved-change not made yet – The comment has been resolved by the document hasn’t been updated to reflect the change.
3. Closed – The comment has been resolved and the change has been made in the document.
viii. Assigned To – Team Responder – The person who is assigned responsibility for resolving the comment. This person is a registered team responder and is visible in the selection list. Provided by Team Responder.
ix. Assigned to - External Person - The person who is assigned responsibility for resolving the comment. This person is not registered in the comment tracking tool, so no selection list is available. Provided by Team Responder.
x. Related Comments – The comment numbers of comments that are related to this comment. Provided by Team Responder.
xi. CDISC Disposition Description – A text explanation of how the comment is being resolved. Should include the rationale for the disposition.
xii. CDISC Disposition – A drop-down list of choices for how a comment is being resolved. Provided by the Team Responder.
1. Question answered – Use this disposition if the comment is a question that has been answered.
2. Considered for future – Use this disposition if the comment will be considered for a future release, but not the next release.
3. Persuasive – Use this disposition if the change requested in the comment is accepted and the change will be made as proposed in the comment.
4. Persuasive with mod – Use this disposition if the comment is accepted but the change made is different from the proposed solution.
5. Not persuasive – Use this disposition if the comment is not convincing or is unclear.
6. Not persuasive with mod – Use this disposition if the comment is not convincing but changes were made based on the content of the comment.
7. Considered-no action required – Use this disposition if the comment was considered but nothing is required as a result of the comment. An example of this type of comment would be a compliment for a job well-done. There is no action being requested.
8. Out of scope – Use this disposition if the comment is considered not related to the document under review.
xiii. Document Impact – A drop down list of choices for a subjective assessment of how this change affects the document. Provided by Team Responder.
1. Low – Use this impact if there is little or no effect on the document.
2. Medium - Use this impact if there is some but not a lot of effect on the document.
3. High - Use this impact if there is quite a bit of effect on the document.