The landing page of the Humans module is the Active Protocols page.
The Active Protocols page is a summary of human protocols the user has access to with an overall status of ‘Active’, ‘Hold’ or Hold-Lapsed’.
Active protocols have completed the full sign-off and IRB review process and have been approved.
Hold protocols are subject to appropriate notification. For example, a protocol has a status of hold if a meeting board has taken the action to place the protocol on hold.
Hold Lapsed protocols are subject to appropriate notification. For example, a protocol has a status of hold-lapsed if a Continuing Review is in progress but the expiration date has lapsed.
On the Active Protocols page, if a user has the ability to access several records, Insight may require that the user hits the ‘Search’ key, and preferably limit the search by entering search criteria before doing so. No search results will display until the search is performed. This rule applies to users who have been granted access to data through the Insight Admin module with the following conditions:
User has access to more than five Principal Investigator’s portfolios OR
User has access to more than one Organization
Search results can be filtered by Principal Investigator (PI), Organization (ORG), or any of the page specific search criteria available (Protocol # and Title). Additional search criteria fields can be found by clicking the ‘Advanced Search Options’ link.
Based on the selection criteria and security access, protocols are filtered and displayed. All information displayed on this page is read only and, therefore, cannot be modified. The following columns appear in the search results grid; Protocol #, PI Name, Title, Sponsor Name, Overall Status, Consent Form, Pending IRB and Approval Expires. All columns, except Consent Form and Pending IRB, can be sorted by clicking on the column header title link.
The arrow indicates the screen is sorted to that column in either ascending (up) or descending (down) order. The default sort order of the data is descending Protocol #, in which the protocols submitted most recently are displayed at the top of the grid. The text for Title and Sponsor Name has been limited on the screen for display purposes, but the entire contents can be viewed by placing the cursor over the field. The Title is a link which, if selected, navigates the user further into the record to the Protocol Details page.
The page displays 20 records per page. If a user has access to more than 20 records, the paging links located at the top right or bottom right of the grid (First Page | Previous Page | Next Page | Last Page) will allow the user to scroll through all records.
Information can be downloaded by clicking on the ‘Download to Excel’ link or the ‘Download to PDF’ link located on the page title bar.
Screenshot with Expanded Search option:
Main Screen Elements
Column Name |
Description |
Protocol # |
A unique number assigned by Research Express for tracking the protocol. This number will remain throughout the entire lifecycle of the protocol. |
PI Name |
The name of the Principal Investigator staffed to the protocol (in the format Last Name, First Name). |
Title |
The title of the protocol. |
Sponsor Name |
The name of the sponsor. |
Overall Status |
The overall status of the protocol, including the project status. |
Consent Form |
Consent forms for the study will be shown in a read-only PDF view. Multiple consent forms may exist for a single protocol. If this is the case, the user will be prompted for the Study Population. |
Pending IRB |
A list of the submissions for the protocol that are pending review by the IRB, i.e. Continuing Reviews, and Amendments. |
Approval Expires |
The date the protocol needs to be reviewed by in order to maintain an Active status. |
The Humans Active Protocols tracking page has a ‘Consent Form’ column that contains any approved consent forms for the study. The consent forms will be read-only PDF’s that cannot be modified, but can be viewed and printed for easy use by the research community. If there are multiple consent forms, a selection page will allow the user to select the correct consent form for viewing/printing. Consent forms will include the footer at the bottom with the correct approval dates.
Screenshot showing the Consent Form column:
Screenshot showing consent form selection when multiples exist:
Consent forms can be uploaded electronically on the Attachments page for a particular protocol. The consent form is available to the user on the Active Protocols page once it has been published by the Protocol Administrator.
For legacy protocols, an Amendment can be submitted with an electronic Consent Form which will then allow the Consent Form to be available in Insight. The title given to the consent form will become the study population name for the approval footer. Consent forms will not be visible on the Active Protocols page until the Protocol Administrator for that specific protocol publishes the consent forms. This can be done from a grid on the Protocol Details page. In addition to publishing the correct consent forms, the administrator can also select the appropriate Amendment #, if applicable, to include on the footer.
Screenshot showing adding consent form attachments:
Screenshot showing how to publish consent forms: