The Humans module within Insight provides the ability to add attachments to a protocol process for the submission of an Amendment, Continuing Review, Adverse Event or Other Event. Attachments can always be added when processing a Continuing Review, Adverse Event or Other Event. Amendments require new attachments or new versions of attachments when the protocol amendment indicates that attachments will be modified or that there is a change in a Performance Site.
Attachments are added or modified on the Attachments page. There is a column on the page called “Include with Submission”. If a new attachment is added or an existing attachment is versioned, this box will be checked by default and the submission will then include the updated or newly added attachments.
Screenshot: Attachments Page for a process
Protocols can only have one attachment type of “Protocol Summary” and “Detailed Protocol”. If a user clicks “add row” and chooses attachment type of “Protocol Summary” or “Detailed Protocol” which already exist on the protocol an error message will appear. This informs the user that new versions of these attachment types can only be added by adding a new version of the document, not a new row with this attachment type.
Protocols can have multiple rows for attachment type of “Consent Form”. However, often times a new version of the Consent Form is required and not an entirely new document, so in this case a warning message will appear.