Required Fields for Saving Document

A self-explanatory section, the four fields collect a minimum amount of basic information to uniquely identify the new document. Once filled out, you have the ability to click the global save button at the bottom, center of the screen. A successful save provides you with the ability to sign out of KC and return at a later time to continue to populate other fields in the Protocol document.

	For more information about initiating a document, see “Initiating a Document” on page 107 in Common E-Doc Operations.
	For more information about saving a document, see “Saving a Document” on page Error! Bookmark not defined. in Common E-Doc Operations.
	For more information about searching for a saved document, see “Searching for a Document” on page 114 in Common E-Doc Operations.

Figure 1103 Protocol Document Protocol Page - Required Fields for Saving Document Section

Table 319 Protocol Document Protocol Page - Required Fields for Saving Document Section Descriptions

Field	Description
Protocol Type	Required. Indicates the intended use of the protocol. This may imply the level of review the protocol likely will require, however, the final determination is typically made by the IRB prior to review. Select one of the following options: Emergency Use, Exempt, Expedited, Full Board, Humanitarian Use Device (HUD), Single Patient Use or Standard. By default, the system defaults to Standard. Use the drop-down menu by clicking the down arrow to display the list, and then click on an item in the list to highlight and select it to populate the box with your selection. Your institution may have modified or added to these available values. See the Protocol Type maintenance document for more information.
Title	Required. Click within the text box (or press the tab key from a previous field) to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter text in the box as necessary to provide the appropriate information. Click the add note icon to view/edit/paste text in a new browser window, then click the continue button to return to the text entry field in the document. After saved, click the green arrow symbol to view full text in a separate browser window.
Principal Investigator	Required. Click the lookup icon to search for and return the value to populate the box automatically with the Principal Investigator you want to designate (either Employee or Non-Employee). The display of this selection becomes read-only after saving.
Lead Unit	Required. By default, this is the primary home unit of the PI, as defined in the KC Person table. It is automatically populated after selection of the Principal Investigator in the preceding field. Type the suspected value in the box and click the direct inquiry icon or click the lookup icon to search for and return the value to populate the box automatically. This value becomes read-only after saving. Additional units may be specified on the Personnel page.

The Description field in the Document Overview section is the one field outside this section that is also required to save a draft of a new Protocol document.