For Humans, the Data Management Page is used for maintaining master lists for drugs and devices. Research Express (ReX) allows for maintenance of drugs and devices that will be used as part of human-subjects research via the Drugs & Biologics and the Devices modules respectively. Although ReX contains these master lists, there is no validation to prevent duplicate entries and there is no cross-reference from ReX to the Insight application.
The following columns appear on the Humans Data Management page: Category, Protocol, Requested On, Name, Submitter, Accept, Reject. All columns, except Accept or Reject 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 ascending Requested On, so items appear in the order of the date / time they were requested on.
The page displays 20 records per page. If there are 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.
An UPDATE button is located at the bottom right of the grid just below the (First Page | Previous Page | Next Page | Last Page) links and functions as follows:
‘UPDATE’ – Clicking this button will save the changes from the Accept, Reject boxes. All items that were updated will then be removed from the page.
Sample Screenshot
Humans Data Management
Main Screen Elements:
Column Name |
Description |
Category |
Indicates if the new entry is a ‘Drug’, ‘Biologic’, ‘Dietary Supplement’ or ‘Device’. (Not displayed for Conflict of Interest). |
Protocol # |
Once a protocol is submitted the protocol number will display on the page. The Protocol # will not be a link, as protocols that are Work in Progress do not have protocol numbers. (Not displayed for Conflict of Interest). |
Requested On |
The date the new drug or device was requested to be added. |
Name |
The name is a link that navigates the user to the appropriate form for administrative evaluation. |
Submitter |
The person who is creating the new protocol application within Insight, and is therefore designated as the Submitter. |
Accept |
The check box in the ‘Accept’ column allows the administrator to accept the new drug or device, so the record will remain in the drug/device table and continue to be available for selection. |
Reject |
The check box in the ‘Reject’ column allows the administrator to reject the new drug or device, so the record will be deleted from the drug/device table and no longer be available for selection. |