Identifying a Case as SUSAR

If the administrator has set the "SUSAR Calculation” to ON, then depending on the details entered in the case, the application automatically classifies the case as SUSAR and selects the check box  SUSAR in the "Assessment” and "Full Data Entry” pages.

Criteria for Identifying a Case as "Suspect Unexpected Serious Adverse Reaction”

Full Data Entry Page You Need to Open

        What You Need to Do

Product

Set the Product type as Drug and the Product Flag as Suspect.

Or

Set the "Product type” as Vaccine and the "Product Flag as "Vaccine Given on Same Day”.

Or

  • Set the 'Product type’ as Drug or vaccine or Combination

  • Product flag to Suspect

  • Do not select Not Relevant flag.

Event

1. Specify the event type as "Adverse Event/Reaction” or "Both”; only then the application identifies the case as a "Suspect Unexpected Serious Adverse Reaction”.

2. Set the Reporter Assessment or Company Assessment as "Serious” in the AE Characteristics window.

 

To open the AE Characteristics window, click the AE characteristics link in the  Event Data entry page.

 

Labeling

In the Product Reaction Labeling section, select the Country as International and Labeling information as Unlabelled.

Causality

In the E2B Causality window, select the "Source” as Company, Headquarter or Reporter.

Select a "Result” of the E2B Causality, that matches with the "Related Causality” in admin; only then the application identifies the case as a "Suspect Unexpected Serious Adverse Reaction”.

 

Calculating SUSAR for Study cases

For clinical trials study case, if the administrator has set the validation 5048 to ON, then depending on the details entered in the case, the application automatically classifies the case as SUSAR.

The application considers a case for SUSAR calculation only when the study type is clinical trial, the case is not considered for SUSAR, albeit the source of the adverse

event is Clinical Study.

Criteria for Identifying a clinical trials study case as "Suspect Unexpected Serious Adverse Reaction”.

 

Admin Settings

Click Setup>Validation information Maintenance

  1. Search for the Validation ID 5048, by default this is set to OFF.

  2. Turn the validation status to ON.

  3. Save the settings.

  4. Similarly search for Validations 5024, 5027 and 5033, to set the validations status to ON.

ARISg settings

  1. Create a case with required data and save the case.

  2. Enter the details as follows:

    Product tab

1)    Select FDEàProduct tab,

2)    Enter Product Description and select any of the following Product flags

·         Suspect

·         Drug Not Administered

·         Interacting

Event tab

1) Select FDE>Event.

2) Enter Reported term and Time Flag as Current reaction.

3) Select Event Type as Adverse Event/Reaction or Both option.

4) Set Reporter Assessment and Company Assessment as Serious.

5) Enter Seriousness criteria.

Causality tab

Select FDE>Causality

Enter Company and Reporter causality fields.

Labeling tab

1)    Select FDE>Labelling.

2)    Select International from Labeling Country and Unlabelled fom Labeled? (J2.14/G.k.9.i.CN.1) drop-down.

3)    Select IB (Investigator’s Brochure) from Labeling Country and blank from Labeled? (J2.14/G.k.9.i.CN.1) drop-down.

4)    Select IB (Investigator’s Brochure) from LabelingCountry and Unlabeled from Labeled?(J2.14/G.k.9.i.CN.1) drop-down.
     The application first considers Unlabeled record for Investigator’s Brochure and does not consider Labeled record for this country.

5)    Select Core from Labeling Country and Unlabelled from Labeled? (J2.14/G.k.9.i.CN.1) drop-down.

6)    Select USA from Labeling Country and Unlabelled from Labelled? (J2.14/G.k.9.i.CN.1) drop-down.
     The application considers unlabeling records for International or Core countries, if Investigator’s Brochure is not available.

 

Study tab

1) Select Clinical trails from Study Type drop-down.

2) Save the case.
    SUSAR flag in Labeling is selected.