Enter event assessment information

The Event Assessment tab enables you to capture causality and listedness information for a case. Causality can be captured for both company and non-company products for study cases.

You can enter labeling information in the Event assessment page manually or it can be determined automatically. Labeling data is entered for all licenses pertaining to company suspect products against all the events present in the case. In clinical trial cases, labeling information can be entered for non-company products that are part of Study configuration.

A pre-requisite for auto-labeling is to have active datasheet versions associated with the Product licenses in the License configuration screen.

Non-clinical trial cases

Labeling is assessed based on the latest datasheet revision and by using the below logic:

If the event entered in the case is present in the latest datasheet revision, then the Labeled field is populated.
If the event entered in the case is not present in the latest datasheet revision, then the Unlabeled field is populated.
If the Product license is not configured with a datasheet or associated with a datasheet that is not activated even once, then the Unknown field is populated for labeling information and Unspecified is populated for the datasheet name and revision #/name is not displayed.
Overall listedness for the datasheet is populated as Listed, Unlisted, and Unknown based on the labelling information of all licenses within a product.

Clinical trial cases

The Study Configuration screen allows you to set the datasheet revision for licenses associated with study products.

If datasheet revision is set for the licenses in the Study configuration, then event assessment is computed based on datasheet revision that is configured or prior datasheet versions, based on the below logic:

If the event entered in the case is present in the datasheet revision, then xx configured for that product license in Study
- If the Onset date is later on equal to the activation date (the datasheet revision that is configured in Study), then the event assessment is performed using that revision. If there are multiple datasheet revisions with the same activation date, then the system takes the most recent revision into consideration.
- If the Onset date is prior to the activation date, then the system matches the Onset date of the event with the activation date of the previous revision number, and this continues until it finds an Onset date later or equal to the activation date. It is not recommended to have the Onset date set earlier than the activation date of all revisions, however if this scenario occurs, then the datasheet revision does not get listed in the event assessment and listedness assessment for that license is displayed as Unknown.
If the event entered in the case is not present in the datasheet revision configured in Study but present in prior version such as xy and if the Onset date of the event is later the datasheet revision xy’s activation date, then the datasheet revision xy is considered for listedness evaluation and the Labeled field is populated.
If the event entered in the case is not present in the datasheet revision xx configured in Study and its prior versions, then datasheet revision xx is considered for listedness evaluation and the Unlabeled field is populated.
Overall listedness for the datasheet is populated as Listed, Unlisted, and Unknown based on the labelling information of all licenses within a product.
If there are conflicting listedness within same datasheet for Product, the system displays the *** symbols for Overall listedness for the datasheet.

The listedness assessment for clinical trial cases is based on the same logic as non-clinical trial cases in the following situations:

For non-study products within a Study case;
Study products for which datasheet revisions are not configured in Study configuration;
Company study products in non-company clinical trial cases;
Company products that are part Blinded study and are marked as open labeled products.

Note:
If the Onset date is not specified in the Event section, then the initial received date is considered. If the Onset date is set at an imprecise date, then the system considers June as the missing month and 15 as the day for missing day component and thus matches the Onset date with Activation date and then performs the event assessment.

All cases

Datasheet revision number/name and activation date is displayed as per the datasheet revision that was used for listedness computation and it is displayed against each of the licenses grouped under the datasheet.

Withdrawn date plays a role in listedness determination and this logic is common to both Clinical and Non-Clinical trial cases.

If a Product license has a withdrawn date, then the following logic is applied:

If withdrawn date >= initial received date, then the system performs the event assessment displays the License number and Revision number/name.
If initial received date > withdrawn date, then the license does not get listed in event assessment and its corresponding assessment is not shown.
If all licenses within product are withdrawn, then the Datasheet name is shown as Unknown and Overall Product listedness is displayed as Unknown.
If Products has both withdrawn and non-withdrawn licenses and are associated with same datasheet, then datasheet name associated with Active licenses are displayed and Overall Product listedness are displayed based on the active licenses instead of Unknown.
If Products has both withdrawn and non-withdrawn licenses and are associated with different datasheet, then the logic specified in c) and d) are used for displaying datasheet name and Overall listedness is based on active license.

Parent topic: Enter event information