Protocol Contingency

 

The Protocol Contingency 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 values in the Protocol Contingency maintenance table become available for selection by reviewers and IRB administrators as a review comment for the IRB protocol. Institutes can establish commonly used review comments within the Protocol Contingency maintenance table. The comments stored in Protocol Contingency maintenance table can be accessed by activating the “Standard Comment” lookup icon within the review comment panel.

Document Layout

Figure 1923 Protocol Contingency Maintenance Document Example Layout

Edit Protocol Contingency Section

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

Table 873 Protocol Contingency Maintenance Document - Edit Protocol Contingency Section Field Descriptions

Field

Description

Protocol Contingency Code

Required.  Enter a numeric value that uniquely identifies the protocol contingency 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 description of the protocol contingency (long description text content).  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 1924 Protocol Contingency Maintenance Document Example Values

Common Features

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

Table 874 Links to Common Maintenance Document Component Instructions

Common Maintenance E-Doc Component

Cross-Reference Links To Usage Instructions

Document Header

link.png  For more information, see “Header Area” in E-Doc Fundamentals.

Document Overview Section

link.png  For more information, see “Document Overview”  in Common E-Doc Tabbed Sections.

Notes and Attachments Section

link.png  For more information, see “Notes and Attachments”  in Common E-Doc Tabbed Sections.

Ad Hoc Recipients Section

link.png  For more information, see “Ad Hoc Recipients”  in Common E-Doc Tabbed Sections.

Route Log Section

link.png  For more information, see “Route Log” in Common E-Doc Tabbed Sections.

Action Buttons

link.png  For more information, see  “Action Buttons”  in Selection, Entry and Action Tools.

Process

link.png

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.