Reviewing Medical Information

This screen helps the medical reviewers to review the medical information for accuracy.

To review the medical information:

On the Forms > Full Data Entry > click Medical Review Screen.
The Medical Review screen displays.

The yellow summary bar in the Medical Review screen displays data from the event assessment (blind) section only.

Data entered under Event Assessment tab gets reflected only on selection of the product and the corresponding reported term.

The pop icon S in the Event Assessment grid indicates seriousness criteria.

Note: The Null flavor value for the product description is displayed in Red in Detail Info screen and in Medical Review More screen, it is displayed in orange color.

Field description of Medical Review screen:

Field	Description
Event Description	The Information entered in FDEàNarratives appears in Event Description section.
Company Remarks	The information entered in FDEà Narratives appears in Company Remarks screen and it can be modified.
SUSAR Summary	The information entered in FDEà Narratives appears in SUSAR Summary screen and it can be modified.
Seriousness as per reporter	The information entered in FDEàEvent screenàReporter Assessment appears in this section.
Reporter Outcome (B.2.i.8/E.i.7)	The information entered in FDEàEvent screenàReporter Assessment appears in this section.
Source (A.1.4/C.1.3)	The information entered in FDEà General screen appears in this section.
Sponsor type	The information entered in FDEàStudy Screen appears in this section.
SUSAR	The information entered in FDEàGeneral à Admin screen appears in this section
Gender	The information entered in FDEàPatient screen appears in this section.
Age	The information entered in FDEàPatient screen appears in this section.
Reporter Type	The information entered in FDEàEvent ScreenàReporter Assesment appears in this section.
Category	The information enteres in FDEà Generalà Case specific information appears in this section.
Case Significance	The information enteres in FDEà Generalà Case specific information appears in this section.
Additional Questions	The information entered in FDEàFormsàMedical Review appears in this section and it can be modified.
Event Assessment	The information entered in FDEà Product, Event, Labelling and Casaulity information appears in this section.
Event Assessment (Unblind)	The information entered in FDEà Product, Event and Casaulity and labelling information for unblind product appears in this section. Select the more link to view the labeling information about countries other than USA, Core and IB if any. Y represents Labeled N represents Unlabeled Note: This section appears only when unblind products are present in a case.
Patient History Including Pre-Existing Medical Conditions (B.1.7.2/D.7.2)	The information entered in FDEà Patient and Disease screens are displayed in this section.
Detailed Info. link	Displays the assessment for all drug - event combinations and labeling information for all the applicable countries in a single screen.
Suspect Product Event Assessment	The Suspect product entered in the product screen appears in this grid. This section contains event, causality and labelling information of USA, Core and IB. The labelling information related to all the countries is available in the more link. The More link is highlighted to indicate the labeling data is present for countries other than USA, Core and IB. If labeled, then the value is represented as “Y”, if unlabeled then the value is represented as “N” and it remains blank if no record is available.
Unblinded Product Event Assessment	The unblinded product entered in the product screen appears in this grid. This section contains event, causality and labelling information of USA, Core and IB. The labelling information related to all the countries is available in the more link. The More link is highlighted to indicate the labeling data is present for countries other than USA, Core and IB. If labeled, then the value is represented as “Y”, if unlabeled then the value is represented as “N” and it remains blank if no record is available.
Other Products Event Assessment	All other products other than the suspect product entered in the product screen appears in this grid. This section contains event, causality and labelling information of USA, Core and IB. The labelling information related to all the countries is available in the more link. The More link is highlighted to indicate the labeling data is present for countries other than USA, Core and IB. If labeled, then the value is represented as “Y”, if unlabeled then the value is represented as “N” and it remains blank if no record is available. Note: If non-suspects products are unavailable, then the Other Products Event Assessment Grid does not appear.
Patient History Including Pre-Existing Medical Conditions (B.1.7.2/D.7.2)	The information entered in the patient screen appears in this grid.
Lab Data	The information entered in the lab data screen appears in this grid. The information in Result unstructured data and comments fields can be modified.