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In the Document Review dialog box, you can document the disposition of the drug-event combination. If your site has integrated Signal Management with topics, you can associate a topic with the combination.
The Comment drop-down list contains all the comments that are defined in the signal management configuration, where one of the following is true:
If no comment yet exists for the drug-event combination, then the Comment drop-down list displays <Select a comment>. If you want to clear the existing comment, from the Comment drop-down list, select <Clear Comment>.
When you clear a comment, a new blank comment is added and the drug-event combination has no comments. The No Comment column on the Drug Comments page counts the drug-event combination as having no comment attached. All previous comments are retained and can be viewed on the View Signal History dialog box and when viewing detailed comments for a drug.
In addition, you can include additional information in the Detailed comment text field.
Note: The Detailed comment text field appears only if the Allow Free Text Signal Comments site option is enabled.
A drug-event combination can be suppressed to not be included on the Drug-Event Combinations page. For example, if you determine that a drug-event combination has already been reviewed, you may want to suppress that combination.
There is a view that includes only suppressed (previously referred to as filtered) drug-event combinations so they can be easily identified.
If a drug-event combination has been suppressed, the Filter column shows YES. If the combination was suppressed and then unsuppressed, this column shows NO. If the combination has never been suppressed, this column is empty.
You can suppress a comment for a drug-event combination by selecting the Suppress drug-event combination checkbox. The Suppress drug-event combination checkbox appears if at least one comment in the signal management configuration is set as Is Suppress Reason? = Yes. It is enabled if you selected a comment with Is Suppress Reason? = Yes.
If signal management is integrated with topics, then you can associate a topic with a given drug-event combination in the Document Review dialog box. If the integrated topic workflow configuration differs from the workflow configuration used on the Topics tab, the Document Review dialog box includes the topic workflow configuration name that is integrated with signal management.
Note: A drug-event combination can be associated with only one topic at a time. However, you can change or remove the currently associated topic. The history of previously associated topics is visible in the Comments and Topic Associations table that appears on the View Signal History dialog box.
You can select any of the following during the review:
If you select this option, comments and detailed comments are logged along with a topic association. The drug-event combination is saved to the existing topic as an attachment.
The comments and detailed comments are logged along with a topic association. The drug-event combination is saved to the new topic as an attachment. When you click OK, the Topic page is displayed and you can edit the associated topic.
If a topic is already associated with a drug-event combination, the Document Review dialog box displays the associated topic name along with the Change link. To view the information about the associated topic in the Topic Association section, click Change.
Another user can edit a topic while you are associating that topic with a drug-event combination, however, if the other user closes or deletes the topic during this time, you are prevented from making the association, and an appropriate error message is displayed.