About collecting adverse event data when integrating with Safety

Collect adverse event data as you fulfill your data collection tasks, keep track of safety cases, and ensure their transmission to Safety.

Depending on the study design, subject adverse event data is integrated with Safety, streamlining Serious Adverse Event data collection.

Permissions

You must be assigned to a study role that includes the Cancel a Safety Case and Modify a Safety Case permissions in order to take additional actions on safety cases.

Notifications

Depending on how your study is configured, you may also receive one or more of the following notifications:

Prerequisites

For safety cases to be submitted to Safety, the following conditions must first be met:

A sponsor user has enabled the transmission of adverse event data from Oracle Clinical One Platform to Safety.
Study designers have configured particular forms of your study to be sent along with adverse event data to Safety.

Workflow

For Oracle Clinical One Platform to send collected adverse event data to Safety, the design of your study must include a form that triggers the creation of a safety case. It must also include forms whose data is included in the safety case, some of which can be mandatory.
Once you provide a triggering answer to the triggering question, as well as any other required information, Oracle Clinical One Platform automatically transmits adverse event data to Safety, along with any other subject data study designers have marked for inclusion.
Once site users finish collecting adverse event data, Oracle Clinical One Platform automatically sends the safety case to Oracle Clinical One Digital Gateway, provided that you have answered all of the required questions.
Oracle Clinical One Digital Gateway integrates the case to Safety.

To monitor the progress of a case, you can check its status in the Subject History panel. This provides insight into whether you need to take further action to ensure the successful transmission of your case to Safety.

At times, you may need to fill in gaps in data that have prevented the transmission of a case. For instance, whenever mandatory questions have not been answered, this is reflected in the Subject History panel and the Query List. Automatic queries are also raised for each mandatory question that remains unanswered.

Note:

If automatic queries are raised on mandatory questions, the case will not be integrated to Safety until these queries are resolved.

Provided that you have the Modify a Safety Case permission assigned, you can also make changes to the data associated with the safety case, such as including or excluding forms from the case after initial submission.

Note:

You cannot deselect triggering or mandatory questions.

Should your study require it, you can also cancel the transmission of a safety case. For example, a safety case entered in error by a site user can be cancelled.

You should also know that Oracle Clinical One Platform may integrate a follow-up case for an adverse event if important subject data has changed.

Note:

Follow-up cases are integrated with Safety depending on the schedule of the Oracle Clinical One Digital Gateway integration. For a particular subject, all of the updates performed before the integration runs are collected into a single follow-up case, which is integrated to Safety.

Details on data collection

Here are several things you should know about the forms that have been designed for transmission to Safety:

You cannot delete forms whose questions have triggered the creation of safety cases without cancelling the corresponding safety cases first.
You cannot clear or modify the data of a triggering question if there is a safety case associated with it. You must cancel the associated safety case first. If the triggering item is part of a 2-section form, you must first cancel all cases associated with that form prior to clearing or changing the data of the item.

Case statuses

To effectively monitor the safety cases associated with the subjects in your study, you can start by filtering the list of subjects, based on safety case status.

Safety cases can have the following statuses:

Status	Description
Not submitted	Cases that have been created but have not yet been submitted to Oracle Clinical One Digital Gateway. Cases with this status can have mandatory questions that have not been completed. Follow-up cases can also receive this status if the data pertaining to a question that triggered the follow-up has changed.
Submitted	Cases that have been submitted to Oracle Clinical One Digital Gateway. Whenever errors are encountered during the submission process, you can address the cause of the error and resubmit the case.
Accepted	Cases that have been accepted by Safety.
Rejected	Cases that have been rejected by Safety. Cases with this status are at times accompanied with a comment explaining the justification for the rejection.
Transfer failed	The data has reached neither Oracle Clinical One Digital Gateway, nor Safety.
Canceled	Cases that have been manually canceled by site users. If required, cases with this status can be re-opened and the form selections made for the initial case are preserved.
Dismissed	If a site user dismisses a case with a status of Not Submitted before it ever integrates with Safety, the case receives this status. Cases with this status will not be sent to Safety unless they are re-opened by site users.

For more information on working with safety cases depending on their status, see Manage safety cases.

Queries

Whenever the creation of a safety case is triggered, the Oracle Clinical One Platform creates queries for each mandatory question site users have not completed. These queries indicate which specific question requires data to be provided before the safety case is created and integrated to Safety. Once you have entered the missing data, the associated queries are automatically closed. Ultimately, once you have resolved all of the queries, the case is automatically submitted by Oracle Clinical One Platform.

Note:

Mandatory questions can be included in any visit. This means that queries can also be opened in any visit.

Modify an existing safety case

Provided that you have the Modify a Safety Case permission assigned, you can modify a safety case after its initial submission. For more information on how to perform this task, see Edit a safety case.

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