Important study design considerations

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

Include one Adverse Event per Argus case or multiples

Each Argus case can include only one trial subject. However, a case can be made up of one or multiple adverse events for that subject. Decide whether each Argus case should contain only one adverse event, or multiple related adverse events.

If you choose to have one adverse event per case, you have two options on how you set up your forms:
- Include a Safety case form.
- Don't include a Safety Case form (all AE information would be on the AE form).
If you include multiple adverse events per case:
- If all adverse events need to be selected by the site, you need a Safety Case form.
- If some adverse events need to be sent via time frames, you can choose whether or not to include a Safety Case form. If you include a Safety Case form, adverse event data will not be sent to Argus until this form is filled out by the site. Any other relevant adverse events are sent via the time frame specified in the InForm Publisher configuration.

Allow InForm site users to base what's sent on their clinical judgment

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

Send related information to Argus

Consider what other relevant information should go to Argus: medical history, concomitant medications, lab results. Will you send this information according to time frames you set in InForm Publisher or via an InForm site user selecting specific items on the Safety Case form?

Review the forms in your study design to see if you need to send data that InForm doesn't need to Argus Safety. Create fixed fields in a fixed repeating section to hold data that is not collected through InForm but needs to be transmitted to Argus Safety.

For example, sometimes lab forms do not collect the lab test name in an item but instead have it as a label or prompt on the form. For more information, see Create fixed items in a fixed repeating section.

Fine tune your rules

Should only serious adverse events go to Argus? 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?

Identify data used by InForm Publisher

These items are mapped to the appropriate data series in one of the following Argus Safety data sets built into Central Designer:

Safety_Config—Identifies items and forms used by InForm Publisher for safety processing. For example, the Safety_Config data set includes a required data series mapped to a control in the AE form so that InForm Publisher can identify the AE forms in the study.
Safety_Significant—Identifies items that are monitored for changes after initial transmission to determine whether update transmissions are needed. The items mapped to data series in the Safety_Significant data set are considered significant for safety and trigger a follow-up for safety integration when changed. For example, if an AE item containing data about a reaction recurrence is mapped to a data series in the Safety_Significant data set, an update transmission is triggered when a user changes the data in the reaction recurrence item.
For details on downloading and importing the data mappings and data sets, see Step 3: Map the safety event data items from InForm to Argus Safety in Central Designer.