To use the Adverse Event Module in SMART-TRIAL you will need to enable the "Adverse Event Module" as an add-on in the study builder. When it is enabled, you will be able to select one of the pre-defined AE templates.
When one of the templates is selected this will act as the active AE form in your study. You can decide to create a custom AE form from scratch even after selecting an AE template. The AE form is created the same way as a regular form, except it has some extra functionalities allowing it to function within the Adverse Event Module. You can change the "Active AE form" in the study builder up until the study has been started.
The AE form CAN be amended after the study starts (data collection) i.e. add/remove questions and change texts.
In this article, a description of the different AE form-specific elements and their functionality is presented.
AE form templates
AE templates are pre-made AE forms meant to suit a specific type of study (Pharma or Medical Device) or a specific reporting standard (e.g. MDR or MDD). Allowing you to quickly create an AE form that only requires minor adjustments to fit your study.
Currently, there are four selections in the drop-down:
- Medical Device MDR/ISO14155 v2.0
- Medical Device MedDev/ISO14155 As of May 26th, 2021 this template is no longer recommended as per MDCG 2020 10-1
- Pharma/basic research
The first three are pre-made forms and the last one will give you an empty form to start from scratch.
If you wish to create your own form from scratch, you will have to create it as a regular form and select "AE Form" in the form type. Select the "empty" option and start building your questions as you would in a regular form.
If you wish to use one of the templates, select the one that best fits your study.
The templates consist of a number of pre-made questions and these can be edited just like a regular form.
Changing anything in a template will change the Form template field from the originally selected template name to "Custom". If you wish to reset the template, you can always just reselect the template or create a new form.
Should you have any comments or suggestions for improvements of a template or a new template, please let us know at firstname.lastname@example.org
When form type is selected, two new dropdowns will be shown: 'Form Template' and 'Sponsor Involvement'
Sponsor involvement determines both how involved the sponsor is but also how long the AE report flow is.
Regardless of the sponsor involvement chosen, users who have to take action on the AE will be notified either via email or in-app notifications, depending on the urgency.
Investigator (and sponsor if involved) will always be notified via email when an SAE report is created.
Always involve sponsor
Selecting 'Always involve sponsor' will use the long AE report flow, and requires the sponsor to be involved on both AE and SAE.
We recommend this setting for any studies wishing to adhere to ISO14155 as a sponsor is required to classify every AE.
Long AE report flow
Involve sponsor on SAE
'Involve sponsor on SAE' will, as the name suggests, only involve sponsors if an SAE is registered.
The AE report flow will be short for AEs (see image below) and long for SAE (see image above).
Never involve sponsor
Selecting 'Never involve sponsor' will use the short AE report flow, as the sponsor is not expected to take any action.
It is therefore not recommended to use any Sponsor questions, as Sponsors will NOT be notified of anything by the system.
An example of the short flow is seen below:
Short AE report flow
Changing from a flow using sponsor involvement, to 'never involve sponsor' will change all Fill Out Permissions that were set to 'Sponsor' to 'Reporter'.
The AE form introduces some additional choices when creating questions.
The "Mandatory" selector is different from regular forms, where it is a simple toggle making the question either mandatory or not.
In AE forms, you can select when a question should become mandatory. The options available in the mandatory drop-down depend on the previously selected Sponsor Involvement.
For instance, if you have selected a Sponsor Involvement that uses the long AE report flow, you will have the following options:
- Investigator Assessment
- Sponsor Classification
- Follow up
- Sponsor Sign Off
If 'Never Involve Sponsor' is selected, the options related to the sponsor are removed.
When selecting 'mandatory', you are selecting at which step in the AE report flow, that particular questions must have an answer before study personnel can proceed to the next step in the flow.
E.g.: If you have selected "Reported" for a question, then this question must have an answer before study personnel is able to report the adverse event. Likewise, if you are at the "Investigator Assessment" and looking to sign it, the step will not be possible to sign until all questions with "Investigator Assessment" have been answered.
A question will become mandatory from the step selected and onward, meaning any edits performed on the form, will require the question to be answered before the edit can be saved.
Fill out permission
The "Fill Out Permission" fold-out, allows you to specify which study role is allowed to fill out the specific question.
The three options are "Reporter", "Investigator", and "Sponsor".
Each of the options is tied to specific collaborator permission:
Fill Out Permission
Required Collaborator Permission
Fill out background-color
The background color of the question will change depending on which Fill Out Permission has been selected, to make it easy to distinguish which fields belong to what role.
It is only possible to select one Fill Out Permission per question, so if you wish to have your investigator be able to fill in "Reporter" fields, the investigator should be given the "Report AE" collaborator permission.
Serious Adverse Event report toggle
Possibility questions in AE forms have an additional toggle next to them.
This toggle determines which possibilities, that if selected during fill out, will mark the AE report as an SAE and trigger everything related to SAE.
You can have as many toggles selected as you wish, but as soon as one has been triggered during fill out it will be marked as an SAE.
It is possible to use Module References when creating an AE form, but there are some limitations:
Medication reference: Can be used to create medication that was used to treat the AE directly from the AE itself. This will in turn create a reference IN the medication, to ensure the medication and AE is linked. Please note that this link/reference can ONLY be created from the AE module. You can therefore not link medication to an AE from the medication module.
The medication to which a link was created, will show the AE Report ID and the question text.
You can create the medication in the medication module and then go to the AE report you wish to link, and find the medication in the module reference drop-down, when editing the AE report.
Unscheduled event reference: Can only link to existing unscheduled events. It will not show the link in the unscheduled event.
Adverse Event reference: Can only link to existing AE reports. It will not show the link in the other AE report.
AE Report List
The AE Report list will use the first two eligible questions in the AE form as columns:
In the above image the two questions "Example Question" and "The second example question" are the first two eligible questions in the active AE form and are therefore used as columns.
The eligible questions are:
- Multiple choice
- Multiple response
- Date and time
- Specific Time
- Free Text
- Free Text Single sentence
The first two eligible questions are used regardless of show rules hiding the question(s).
If there is no value due question being hidden by the show rule, the table will show no value for that row