Configuring Study Reporting

Study Reporting is provided in the Study Configuration section to configure study-based reporting requirements.

The reporting rules are not directly defined in the study, but rather identify which reporting rules to check from the already configured expedited reporting rules.

The identification is based on specifying what set of reporting rules to evaluate, as per the criteria of:

• Country
• License Type
• Reporting Destination

Study reporting is available for both Who Drugs and J Drugs. When you are a Japanese user and you click the Add button in either the English or the Japanese Study Reporting section, the following scenarios may occur:

• If the reporting destination contains WHO Drug or J Drug reporting, then you can add a record.
• If the reporting destination does not contain WHO drug or a J drug reporting, the following error message is displayed: There are no Reporting Destinations for which WHO Drug reporting or J Drug reporting is configured. The Japanese error message reads: WHO Drug報告またはJ Drug報告が構成されている報告先がありません

Use the following procedure to configure study based reporting.

1. Click Add in the Inherit Reporting Rules From section. The Study Reporting dialog opens.
2. Select Always Report as required.

   Tip:

   Select this checkbox to force the application to check for qualifying expedited reporting rules. These rules are based on the country, license type and reporting destination specified. Refer to the Field Descriptions for details.
3. Select the Country from the drop-down list.

   Tip:

   This field specifies which country's reporting rules should be included. The drop-down list includes countries for which the expedited reporting rules exist.
4. Select the License Type from the drop-down list.

   Tip:

   This field specifies the license type to be considered for the specified country. Refer to the Field Descriptions for details.
5. Select the Reporting Destination from the drop-down list.

   Tip:

   This field is optional.
6. The Time Frame and Possible Report Forms cannot be searched or altered, but is included for informational purposes.
   • To add information pertaining to inheriting reporting rules in the Study Reporting section, click Add.
   • To delete information pertaining to inheriting reporting rules in the Study Reporting section, select the reporting rule and click Delete. A pop-up appears asking you to confirm the action.
7. Click Save to save the changes made to the Studies section.

   Tip:

   If you have added a new Study, click Add Study to save the new Study.