Protocol Status

 

 

The Protocol Status 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.

The Protocol Status is the primary status indicator for the IRB protocol as it moves through various stages of its lifecycle. Together with the Submission Status, it provides complete information about the current state of the IRB protocol. The Protocol Status is automatically set by the system when a protocol action is performed.

 

Existing Value Modification:  Existing values may be edited as long as the description is synonymous with the original term.  New values can be added.  You should not delete existing values.

Document Layout

Figure 1939 Protocol Status Maintenance Document Example Layout

Edit Protocol Status Section

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

Table 888 Protocol Status Maintenance Document - Edit Protocol Status Section Field Descriptions

Field	Description
Protocol Status Code	Required.  Enter a numeric value that uniquely identifies the protocol status 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 protocol status 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

Figure 1940 Protocol Status Maintenance Document Example Values

Common Features

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

Table 889 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” in E-Doc Fundamentals.
Document Overview Section	For more information, see “Document Overview”  in Common E-Doc Tabbed Sections.
Notes and Attachments Section	For more information, see “Notes and Attachments”  in Common E-Doc Tabbed Sections.
Ad Hoc Recipients Section	For more information, see “Ad Hoc Recipients”  in Common E-Doc Tabbed Sections.
Route Log Section	For more information, see “Route Log” in Common E-Doc Tabbed Sections.
Action Buttons	For more information, see  “Action Buttons”  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”  in the Overview section.