Risk Level

 

 

The Risk Level maintenance document is used to establish and maintain numeric codes and textual description values which are stored in database tables.  This data serves as reference information that is made available for display and selection in various areas of the system, including other e-docs.

Document Layout

Figure 1102 Risk Level Maintenance Document Example Layout

Edit Risk Level Section

The Edit Risk Level section of the Risk Level maintenance document is a unique section that allows you to specify and maintain the details associated with the reference table record in fields.

Table 762 Risk Level Maintenance Document - Edit Risk Level Section Field Descriptions

Field	Description
Risk Level Code	Required.  Enter a numeric value that uniquely identifies the risk level table record in the system.  Click within the text box to relocate the cursor to the field, and then type (or paste from virtual clipboard) to enter the desired value in the box as necessary.
Description	Required.  Enter the full textual name of the risk level as it is commonly referred to (see examples below).  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.  To work with larger screen real estate, 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.

Examples

1.  No greater than minimal risk.

2.  Greater than minimal risk but potential for direct benefit for participant

3.  Moderate Risk

4.  Research involving greater than minimal risk, with no potential for benefit to participant, but likely to yield generalizable knowledge about the participant's condition

5.  High Risk

Common Features

This maintenance document includes the following features that are common to most KC maintenance documents:

Table 763 Links to Common Maintenance Document Component Instructions

Common Maintenance E-Doc Component	Cross-Reference Links To Usage Instructions
Document Header	For more information, see “Header Area” on page 99 in E-Doc Fundamentals.
Document Overview Section	For more information, see “Document Overview” on page 103 in Common E-Doc Tabbed Sections.
Notes and Attachments Section	For more information, see “Notes and Attachments” on page 104 in Common E-Doc Tabbed Sections.
Ad Hoc Recipients Section	For more information, see “Ad Hoc Recipients” on page 106 in Common E-Doc Tabbed Sections.
Route Log Section	For more information, see “Route Log” on page 107 in Common E-Doc Tabbed Sections.
Action Buttons	For more information, see  “Action Buttons” on page 81 in Selection, Entry and Action Tools.

Process

For information about searching for, initiating, editing, copying, submitting, saving, closing, canceling, and/or routing a maintenance document, see “Common Maintenance E-Doc Operations” on page 129 in the Overview section.