Serious Adverse Events (SAE)

Patient safety is paramount in clinical research for that reason all adverse events must be recorded even if there is no causal relationship between the treatment.

Serious Adverse Events in Castor EDC

You can document Serious Adverse Events (SAE) or any other unintended event in Castor using Report forms. As we can not predict if an adverse event (AE) or serious adverse event will happen as well as if there will be only one or many events, using Reports to record AE’s or SAE’s will allow you to have the ability to create unlimited Report’s instances as they are needed, differently from the study form which you can only use as 1 time data capture. You are also able to link a Serious Adverse Events Report form to any phase of a study.

How your SAE paper form will look in Castor

Below, you will have an idea on how your paper SAE form will look from this:

To this:

Step-by-step guide on creating SAE form in Castor EDC

1. Decide if you would like to use a regular report or repeated measurement.
In Castor you will find 2 types of reports: repeated measures and other report types .
The other reports can be the following types: 'adverse event', 'medication', 'unscheduled phase', 'event', and 'other'.
There are several differences between repeated measures and other report types:

• Repeated measures allow to display report data (first 5 variables) in the Record view
• Repeated measure reports can only consist of one step while other report types can have many steps

You can use  repeated measures for AE’s and SAE’s if you would like to display data directly in the Record. If your report consists of multiple steps and you don’t want to display the data in the Record, you can use other report types. To learn more about the different types of reports, you can visit the page What is the difference between the types of reports?

2. Create a report in the Structure tab

Bellow you will find the steps in order to create a SAE report form:

1. Go to the 'Structure' tab
2. Click on 'Reports' to open the Reports structure editor.
3. Click the '+ Add' button to create a new Report.
4. A dialog window will open in which you can enter details about the SAE report you will create such as:
   • The SAE report name
   • The report type
   • A description (optional)
   • Report name strategy (for example, Adverse Event - 20-01-2022 14:13:12)
   • And at last, a tick box to allow (or not) manual editing of the generated name during the data entry.

5. Once you complete the fields, you can click on the “Create report” button.
6. You will be redirected back to the Form editor.
7. The new SAE report will be displayed in the sidebar.

3. Add steps or one step if you are using repeated measurement

To add steps to your report, you need to go to the Structure tab, select your SAE report on the left side column and  click the '+ Add' button to create a new step in it.

Add a step to the report by specifying its position, name and description - click 'Save' to save the step.

Note: The Repeated Measure reports can only have one step, so it is not possible to add another step.

4. Add fields to the forms

To be able to add fields (questions) into your SAE report, you need to go to the 'Form' tab, under Structure, to start adding the fields to your SAE form:

1. Select the 'Reports' sub-tab 

2. Choose the SAE report you have created from the report dropdown 

3. Select a step to which you want to add the fields

5. Add a report button or repeated measurement field in the study forms

You can include your SAE report in your regular CRF (study form) adding a repeated  repeated measure field or 'Add report' button into your study form  to allow users to rapidly access the SAE form from your CRF during data entering. 

Add a report button:

To create a report button, select the 'Add Report Button' field from the list of field types in 'Form' > Study': 

The SAE report is linked to the study form where the report button has been added, allowing you to conveniently keep track of when specific events occurred:

Using repeated measurement field: 

After you have created the SAE report using the repeated measure type, you will be able to add a repeated measure field to the study. 

To generate a repeated measure field, go to the Form builder, navigate to the appropriate study phase and step, and choose the 'Repeated measure' field type. This field can also be added to another report.

6. Get notified for SAEs

It is possible to set up  email notifications  using Castor's Notification feature when an Adverse Event or Serious Adverse Event report is used in the study.

The typical notification system only allows you to be notified when an AE report is created, not when specific data is included in the report. 

You will find the steps to create this kind of notification on the page:  Notifications for Serious Adverse Events

Once you create your SAE version in Castor, you will be able to:

• Enter data into report forms

As we have mentioned before, SAE forms are made in “Report” format. The reason for that is because in Castor, Reports are forms that you can enter data “n” times into the system as well as used for unscheduled events. 

In order to enter data into SAE you can either:

• Go to the “Reports tab” within the Record

• Using a “Repeated measure” field in the study form. 

• Using a “Report button” field in the study form. 

Below, we will go through over these 3 methods in more detail:

To be able to create a report, the first thing that you need is “Edit” rights. If you do not see any of the options described below you should contact your study manager to request adequate access.

Reports tab

The “Reports tab” is within the Record. So you first need to select the record from the Records list that you want to add to the SAE.  After that you will see the tab “Reports” on the left side menu.

1. You can filter by report, report type (event, medication, unscheduled phase, repeated measure or other), report name or by the phase to which a report was attached.

2. Here you can see the list of all reports added to this record.

3. To add a new report, click the 'Add a report' button.

After pressing the 'Add a report' button this dialog shows:

1. Report: First choose which report you want to add to this record. In my example I selected the “Serious Adverse Event” that we have created before.
2. Custom name: here you can define the report name. For auto-generated names this is a preview. The name that will be actually stored may differ as it will be regenerated upon the actual save.
3. Attach to: You can choose to attach the report/SAE form to a phase or another report. By attaching a report to a phase it will get listed in the Phase/Step navigator on the left side of the normal data entry window as well. The Report can also be attached to unscheduled phases. Below you will see an example of how it looks like if you attach a report/SAE into a study phase (in this case, “Follow-up” is a study phase):

Click the 'Create' button to add the report to the record and fill in the data. Click on the 'Create and add another' button to create this report and add another one.

After that, the overview panel will collapse and the SAE report data entry panel will slide up from the bottom of the view:

Data can be entered into a SAE report in the same way as for regular study forms.

Repeated measure field

To simply add data into your SAE form using the “Repeated measure field”, you just need to click on the “Add measurement” button on the right top of the SAE table in the phase and step where you have added the field:After that, the overview panel will collapse and the SAE repeated measure table panel will slide up from the bottom of the view. You may need to click on the “Add measurement” button again and then the layout below to enter data will be displayed:

1. Data that needs to be entered that later on will appear on the table once the SAE report is saved.

2. The “Add measurement” button will create another “SAE form” instance. So only click on it after entering data for the first instance and if you wish to add more data afterwards. 

3. The “Add another” button will also create new SAE instances.  You can either click on it or click on the  “Add measurement” button. 

4. “Close report” will save the data and close the SAE form. 

5. Will take you back to the “Reports” page overview. 

Report button

As shown before, the “Report button” is a field that you add into a study form that allows you easy access to add/create a new SAE form (or any other kind of reports) into that phase and step. 

A pop up window will be displayed:

1. It shows the default SAE report that has been set up previously

2. It shows the variable name created for that instance.

3. Shows the phase that the SAE report is attached to. In this case, the phase that the “report button” is added.

4. Click on “Create” to create the “SAE report”.
   

After that, the overview panel will collapse and the SAE report data entry panel will slide up from the bottom of the view.

The SAE form will be displayed and data can be entered into a SAE report in the same way as for regular study forms.

Import SAE data

Data from SAE reports can be imported by following the steps below:

1. Navigate to the Records page

2. Click on “Actions”, on the right hand side

3. Select “Import”

To be able to proceed with the importing the following columns must be present in the import file: Record ID, custom name, and parent phase (if any). Make sure that each SAE report within a given record has a distinct custom name.

Note: If you're importing data into an existing SAE report, ensure it's unlocked first, because data can only be imported if the report or report step isn't locked.

When you select the "report import" import type, you must map the columns in your file to the appropriate elements

1. Browse to select the csv file you want to import.

2. Make sure you have set this to report to see the following dropdowns.

3. Define the column from your csv-file that contains the record ID.

4. Define the column from your csv-file that contains the custom name of the SAE report.

5. Define the column from your csv-file that contains the phase or custom report name that the SAE report is attached to (if that is the case). If the SAE report is not attached to a phase or report, you can leave this column empty and still select it upon importing.

6. Click on "Upload" to upload the data into your CRF.

Example of a report import file:

Import repeated measure data

Construct an Excel export of your data and select the repeated measure to export (even if you don't have any data yet) - this will create the needed columns to fill in, and you can simply enter your data there.

The only item you don't need to fill in is the 'creation date' column, which is created automatically when the report is created.

This is what your import-ready sheet should look like: 

Delete or archive SAE report data

You can delete or archive a SAE report data from your study. It is important to have in mind that if your study is live you will only be able to archive the SAE report data, not delete. 

To archive or delete a SAE data you need to:

1. Go to the “Reports tab” within the Record.

2. Click on the “cog wheel” by the end of the SAE report row.

3. Select one of the options to “Archive” or “Delete”

Note: 

• If your study is live you won’t see the option to “Delete”.

• When a report is archived, it is not shown in your data overviews and is not exported. Archived reports can be viewed by selecting 'Archived' in the 'Filter by status' menu - archived records are shown with the prefix "ARCHIVED".

Overview of all SAE and other reports recorded on the study

You can have an overview of all SAE reports as well as other reports within your study in the 'Reports' tab. Users can only see reports from records that belong to an institute for which they have "View" rights.

1. You can use the filters in the upper panel to refine your search, including report type selecting Adverse Events or Repeated measures, for example.

2. Using the cogwheel menu, you can archive or print a report.