The Humans module within Insight provides the ability to add attachments to a protocol via the Attachments page. The submitter is presented with a list of the required attachments based on the answers provided when completing the forms. From this list, the submitter designates which attachments will be added electronically and which will be sent in via mail or fax in hard copy format.
For electronic attachments, the submitter can browse to select files to attach and, once all files have been selected, upload them in a single transfer to the protocol by clicking the ‘Save’ button on the page. If attachment mode is selected as a hard copy a word document will appear on the page. Clicking on the PDF icon launches a fax cover sheet that can be printed to include with the document.
Depending on the type of application, there may be attachments that are required in order for the application to pass the validation process. For example, there are two documents that are always required for Intervention/Interaction protocol applications. The protocol will not pass validation until the Detailed Protocol and Protocol Summary have been added to the Attachments page.
Other study specific questions, such as ‘Will written Informed Consent be obtained?’ necessitate the attachment of other document types. In addition to the required attachments identified by the system, the user will be able to upload additional attachments of any file type by clicking on the ‘Add Row’ button just under the grid.
Screenshot: Attachments Page
In the screenshot above, the submitter has navigated to the Attachments page after completion of the forms for an Intervention/Interaction study. The required Attachment Types (Protocol Summary and Detailed Protocol) are listed. An Advertisement is required based on how a particular question was answered on the Recruitment form. The Title ‘Advertisement 001’ is just a unique system generated title that can be edited by the user. Diary 1 is required because the user indicated on the Diaries form that this particular diary was going to be included in the study.
Main Screen Elements
Column Name |
Description |
Attachment Type |
Indicates the type of attachment. If a specific type is not available in the list, select type of ‘Other’ and give the document a meaningful title so it is easily identifiable. (See below for all selectable Attachment Type values). |
Title |
Text box field in which the user can enter a title (short name) of the attachment to further identify the document. If a default value is provided, the user can edit the title. |
Attachment Mode |
Indicates whether the attachment will be Electronic or Hardcopy. Electronic documents must be uploaded at the time that the Electronic box is checked. Hardcopy documents can be sent later. |
Select File |
If the ‘Electronic’ Attachment Mode is selected, the browse button will appear to allow the user to find the file to be uploaded. The name of the file will be populated in the Select File box. If ‘Hardcopy’ Attachment Mode is selected, these fields are disabled as they are not applicable. |
Forms ID |
A unique ID assigned to the submission process. For example, new protocols are assigned IR (Initial Review); Continuing Reviews and Amendments are assigned a sequence number along with the process identifier (i.e. CR3, AME1). |
Date Uploaded |
The date on which the document (selected file) was uploaded to the page. This column only appears after the upload is complete. |
View Attachment |
An icon reflective of the document type uploaded (Word Document, Excel Document, etc). When clicking the icon, the file will open in the correct format. This column only appears after the upload is complete. |
Mark for Deletion |
Allows the user to remove the row from the list by checking the box on the appropriate row in the grid and clicking the ‘Save’ button. If the wrong file was uploaded, the row in the grid must be removed and then re-added. |
Attachment Types:
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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.