An Adverse Event application is started from the Protocol Details page. To start an Adverse Event, select process type ‘Adverse Event’ from the dropdown box located to the left of the ‘Create New Process’ button. The ‘Create New Process’ button will launch the Adverse Event questionnaire. Any user with edit or manage access to the protocol in Insight will have the ability to start a new Adverse Event on a protocol.
Once the Adverse Event questions have been answered and saved, the user is returned to the Forms page where the Adverse Event forms can be modified, if necessary, and then submitted.
The Forms page consists of a grid with 2 columns. The first column is the Adverse Event form itself which can be modified if any answers were completed incorrectly by clicking on the form name hyperlink. The ‘Last Modified’ column will show the date and time that the answers on a specific form were last updated.
An Adverse Event can be submitted with or without electronic attachments. To add attachments, move to the Attachments page. When all changes have been made, navigate to the Submission page to complete the validation and submission process.
Screenshot: Adverse Event Form
Note: Please see the sections in the User Guide for information on Attachments and Validation & Submission.
View Application – Presents the user with a PDF version of the application, which includes all the questions and answers from the Adverse Event form and the list of any attachments that were uploaded as part of the Adverse Event process.
View Full Application – Presents the user with a PDF version of the application, which includes all the questions and answers from the Adverse Event form and the list of any attachments that were uploaded as part of the Adverse Event process. Also included are any electronic attachments uploaded for the Adverse Event process.
Add/Delete Forms – This is disabled as it is not used for Adverse Events.
Delete Application – Allows the submitter or anyone with ‘Manage’ access to the protocol to delete the Adverse Event application. There will be a warning message when this button is selected. Once the application is deleted, it is no longer accessible through Insight.