Copyright - EMEA 2005

SAR SIMPLE AND ADVANCED QUERIES

STEP-BY-STEP GUIDE This step-by-step guide explains how to perform simple and advanced queries in the SAR section of EVWEB.

1 Simple Query ............................................................................................. 2

2 Advanced Querying................................................................................. 3 2.1 Perform an Advanced Query..........................................................3 2.2 Modify an Advanced Query............................................................8 2.3 Perform a Scientific Query ...........................................................10 2.4 Search for Error Reports..............................................................15

2

The EudraVigilance Screen

(Note: For confidentiality purposes, real substances or product names have been

replaced by “xxx” in the examples used throughout this tutorial).

1 Simple Query EVWEB allows the user to perform simple queries, for example: Retrieve a SAR previously sent to the EMEA. Click on the “ADRs” button.

Select “Safety Report (s)” (see above screenshot). An input box appears in the active area. This box allows you to type the Safety Report ID of a case you have previously sent directly to the EMEA.

Tree-view area

Dynamic button set

Active area

3

You can now type in the Safety Report ID of the case you wish to retrieve, or you can enter the wildcard character *, then en press Enter. If you use the * character, the query will bring back a list of reports sent by the organisation for which you are a registered user. If you have entered in a specific Safety Report Unique Identifier only reports with that ID that were sent to the EMEA will be shown (Note: ADRs not sent directly to the EMEA will not appear in this list). The query result will display a list that matches the query criteria. From this list, select a SAR report by ticking the box next to it in the active area. This will load the report into the tree view area (right hand side of the screen), allowing you to navigate the report.

2 Advanced Querying

2.1 Perform an Advanced Query To perform an advanced query, select the section “Queries”. This will open up a list of possible queries you can perform on the EudraVigilance DBMS, relating to the SAR reports.

You can carry out several types of queries: • Case queries • Tracking queries • Repository queries Case queries: Case list (will bring back the most recent version of the report) All reports (will bring back all versions of the reports, i.e. original & follow-ups) Reports Count

4

The case queries menu is also subdivided as “Animal Reports” and “Human Reports”. These subdivisions contain the same menu items as above (Case list, All reports & Reports Count). Messages: Queries the EudraVigilance Database Management System (EVDBMS) (it will bring back only valid messages). Tracking queries: •Message tracking Queries Gateway. ( All messages).

•Message tracking history Queries Gateway archive (Messages from Gateway get archived at

regular intervals).

•Message Processing tracking Used by EMEA. It is our log for valid messages and

acknowledgements

Repository queries: Inbound message archive Outbound Message archive •To Eudravigilance Message Archive Repository for the untouched file, contains message data &

case data

•From Eudravigilance Message Archive Contains Acknowledgements sent by EMEA

(For a detailed explanation of the functions of these different queries please refer to the EVWEB user manual). All query menu items are divided in three sections - “Fields”, “Conditions” and “Results”. 1. Fields section - The “Fields” section is used to define the output of an advanced query. That means that the items displayed in the result will contain only the fields previously selected in this section. 2. Conditions (AND) section - The Conditions section is used to define the criteria of an advanced query. This section allows you to select one or more items and define their value. These items are then used as criteria to filter the results of the advanced query. 3. Results section - Displays the result of the query. From the user’s point of view, the queries may be divided as: • Scientific queries • Administrative queries

5

• How to perform administrative queries: The first query to perform is to find all the SAR Case Reports received on “EVVET test system” this year. Select “ADRs” on the toolbar, and then choose “Queries”, and “Case list”. The following menu will be displayed:

Select “Fields” on the left hand side of the screen. The available options will be displayed:

For this example we will select the default fields. To do this, click on the green button showing a ticked box on the toolbar. This will select all the default fields. (To “unselect” them, click on the “unticked” box button on the left hand side of the previous one)

6

Then select the “Conditions” section

Enter the date for the beginning of the year: 01/01/2005 on the field “Message Receive Date (From)”. This will bring up a list of reports received on EVVET test since the beginning of this year up to today’s date. (You can also limit the query to a particular set of dates by entering an end date on “Message receive date (up to)) After entering the date, click the “Run” button to execute the database query.

7

The query should then return a list of SAR case report that meets the conditions specified on the query; the fields displayed in the active area depend on the selection you made in the fields area.

To load an SAR case report for viewing in EVWEB, tick the check box next to the report you wish to see. This will load the report into the tree view area for browsing.

8

You can return to the results of the queries you have run by re-selecting the results on the left hand side of the screen, and then select other reports to view by ticking the box next to the report on the left hand side of the screen.

In some instances you might wish to run the query again. To rerun the query without changing the parameters click on the “ReRun” button.

2.2 Modify an Advanced Query If you have made a mistake when entering your search criteria, or would like to widen or narrow the results of a query, you can modify the parameters without having to delete the query and start again. If, for example, your query brought back too many reports, you may wish to specify narrower search criteria. (Note: there is a limit of 100 results per query; if your query has more than 100 results only the first 100 hundred will be displayed). In our example, we will change the “Message receive date (from)” to “01/01/2004”. Click the “Modify” button.

9

This will take you to the “fields” section of the query. The options selected for the previous query will be displayed. We don’t need to change anything there in this occasion. Next select the “Conditions (AND)” field.

Now change the date in the active area to “01/01/2004” and click the “Run” button. This will rerun the query with the new parameters.

10

If the “Conditions” that have been set are such that the query does not bring up any results, a pop-up window will appear informing you of this. You can then alter your query conditions and rerun the query if needed.

2.3 Perform a Scientific Query

Now we will run the following query: “What animal case reports were receive between 1/01/05 – 30/06/05 for the Active substance “xxx” with the reaction VEDDRA term “Vomiting”. To perform this query open the “Queries” section, then select “Animal Reports”, and “Case List” from the list of possible queries. In this example we will use the default selection for the fields we want to retrieve.

11

Select “Conditions (AND)” so you can specify the parameters for the scientific query. The

conditions available are listed on the next two screens:

12

The first condition we will set for our query is the active substance “xxx”. Navigate down to

“Suspect Substance Name (contains)” field and select it; a look-up table will appear.

Type the name of the substance “xxx” in the field, and press enter. If the substance is listed on

the look-up table, it will be displayed below. Select it and press Enter.

If the substance is not listed on the look-up table, click on the button “E” on the toolbar, then type the name of the active substance directly on the field and enter. In the active area select the field “Reaction Veddra Term (code)” and enter in the reaction “Vomiting”

Then select “Original received date (from)” and enter 1/01/04, then “Original received date (up to)”, and enter 30/06/04:

13

Now click the “Run” button to execute the query.

The results of the query will be displayed in the active area, if there are reports in the database that meet the conditions of the query.

To view the details of any of these reports check the box in the active area and they will be loaded in the tree-view area for browsing.

• Report / Case count It is also possible to query the number of reports or cases that have been received and that meet certain conditions, for example, for a particular product or substance, for a certain species, or for a specific VEDDRA term. Select “Queries”, “Animal Reports”, “Reports count”. In the fields sections, choose, for example, “Reaction VEDDRA term” and “Cases count”.

14

In the conditions, go to the field “Animal Suspect Brand name”, and type a Product Name

15

Press “Run”. The query result should be “A count of all VEDDRA terms that have been reported for the Product you have selected”.

The results appear in alphabetical order. You can sort these results by clicking on the headings above the figures:

2.4 Search for Error Reports Open the section “Queries” from the tree view area, then “Error Tracking” and select “Report with Errors” from the list of possible queries. In this example we will use the default selection for the fields we want to retrieve.

16

Select “Conditions (AND)” so that the conditions for the scientific query can be specified. The condition we are going to set is the “message receive date”, which is date that the SAR message was received by the EudraVigilance system. Navigate down the active area to the “Message Receive date (From)” and “Message received date (up to) field and enter the dates you wish to query.

Now click the “Run” button to execute the query.

The results of the query will be returned in the active area if there are reports in the database that meet the conditions of the query. In this case, any reports that contain errors and meet the conditions of the query (Received from) will be returned. To view the details of the report(s) check the box in the active area and they will be loaded in to the tree view area for browsing.