Important study design considerations

Because a successful Oracle InForm to Oracle Argus Safety integration depends on your Oracle Central Designer study design, we suggest considering the following issues before adding items to the Adverse Event and Safety Case forms in Oracle Central Designer.

Include one or more Adverse Events per Oracle Argus Safety case as needed

Each Oracle Argus Safety case includes one study subject only, but it can also be made up of one or more adverse events per individual case.

Decide what information is relevant to send to Oracle Argus Safety

Consider what other relevant information should go to Oracle Argus Safety, such as medical history, concomitant medications, or lab results, and how this data should be selected (automatically via time frames or manually using a dynamic grid).

Decide whether the information should be sent automatically or via clinical judgment

Using a Safety Case form and a dynamic grid, allows you to give Oracle InForm site users the option of selecting the specific adverse events and other information they want to send to Oracle Argus Safety, as opposed to only sending relevant data automatically based on time frames.

Fine tune your rules

When creating the rules that define the behavior of your Oracle Argus Safety integration, ask yourself relevant questions, such as: Should only serious adverse events go to Oracle Argus Safety? Are there multiple death or autopsy dates in your study design? Do you need to create rules to copy data from one place to another?

Consider what items need to be mapped to which data series

In addition to items in your forms that need to be mapped to the specific types of data series that are being sent, items should be mapped to the appropriate data series in one of the following Oracle Argus Safety data sets available in Oracle Central Designer:

• Safety_Config—This data set identifies items and forms used by Oracle InForm Publisher for safety processing.
• Safety_Significant—This data set identifies items that are monitored for changes after the initial transmission to Oracle Argus Safety and is used to determine whether updated transmissions are needed. As a designer, you determine the items mapped to the data series in the Safety_Significant data set. These items should be significant for safety and will trigger a follow-up for safety integration when changed.