The initial questionnaire for new protocol creation will ask the submitter if the study involves the use of any devices, as shown below.
If the submitter answers ‘Yes’ to this question, or later adds the Medical Device form to the study using Add / Delete Forms, then a 2-step process to select or add the device to the database and complete the form will follow. The same process will be used for adding/modifying any devices during an amendment.
In this screen shot below, P-Scan has already been added. At this point, the submitter can add another device by clicking the ‘Add Medical Device’ link or remove P-Scan from the study through the Add/Delete Forms page.
Note: that if the user answered ‘No’ to the Device question on the initial questionnaire, the ‘Add Medical Device’ link will not appear unless the Medical Device form is added through the Add/Delete Forms page
To add a new device from the Forms page, click on the ‘Add Medical Device’ link; this will launch a device search page allowing the user to search and select a device. If the device cannot be found, the user can add the new device directly through the page.
Devices can be searched for using either of the categories by selecting the appropriate radio button:
Proprietary Device Name
Common/Generic Name
To find a device, select the appropriate radio button and enter any amount of letters in the ‘name of device’ text box. Click the ‘Search’ button for results. The dropdown list will have all applicable results (i.e. all devices starting with the letters ‘pa’) with the specified name and manufacturer. The manufacturer is displayed in all caps and in brackets.
If the user selects a device from the list, the ‘Next’ button will navigate to the Medical Device form for completion of the device information for the protocol. If the device is not found in the search results, check the ‘Add New Device’ checkbox and then the ‘Next’ button. The ‘Add New Device’ checkbox will not be enabled unless the user first searches for the device.
In the screenshots below, the user has searched for the device using specific search criteria and clicked the ‘Next’ button to navigate to the Device form to complete the information for PainMatcher.
When the submitter checks the ‘Add New Device’ checkbox, the data fields to be manually entered by the submitter will be displayed on the page.
The following information will be requested for any new device:
Type of Device (dropdown box: Proprietary Device Name or Common/Generic Name)
Proprietary Device Name (text)
Common/Generic Name (text)
Manufacturer (text)
Required fields are one of the two Name fields, Manufacturer and the Type of Device (Proprietary Device Name or Common/Generic Name). The ‘Next’ button will bring up the Device questionnaire for the submitter to complete the Device form regarding the use of the device in the research study. The device name associated with the new device questionnaire will be that specified by the radio button selection.
In the screenshot below, the user has clicked on the ‘Add New Device’ checkbox and completed the information for adding a new Proprietary Device. The user then clicks the ‘Next’ button to navigate to the Device form to complete the information for drug named Proprietary 1.