Protocol Action Type

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Protocol Action Type

The Protocol Action Type maintenance document is used to create new and edit existing action codes and names. Each name for an action has a numeric value associated with it, and the out-of-box product contains approximately 40 of them.

These records are 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.

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 1070 Protocol Action Type Maintenance Document Example Layout

Edit Protocol Action Type Section

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

Table 732 Protocol Action Type Maintenance Document - Edit Protocol Action Type Section Field Descriptions

Field	Description
Protocol Action Type Code	Type a numeric value to uniquely represent the protocol action type in the system table record. You may want to group related or similar protocol action types by choosing a 3-digit value so that each is represented at 100-level increments for ease of reference.
Description	Type the textual name of the type of protocol action to which it is commonly referred as (for example, Protocol Created, Submitted to IRB, Renewal Created, Amendment Created, Request For Termination, Request To Close, Request For Suspension, Request for Withdrawal, Request to Close Enrollment, Notified Committee, Correspondence Generated, Renewal Reminder Generated, Reminder to IRB Notification Generated, Administrative Correction, Request for Data Analysis Only, Request to Re-open Enrollment, Notify IRB, Assigned to Agenda, Deferred, Substantive Revisions Required, Specific Minor Revisions Required, Approved, Expedited Approval, Exemption Granted, Closed for Enrollment, Response Approval, IRB Acknowledgement, IRB review not required, Data Analysis Only, Re-open Enrollment, Closed (Administratively closed), Terminated, Suspended, Withdrawn, Disapproved, Expired, Suspended by DSMB, and Record Committee Decision.)
Trigger Submission	Select if you want this action, when taken, to also cause a submission action to occur.
Trigger Correspondence	Select if you want this action, when taken, to also cause a correspondence notification to be sent.
Final Action for Batch Correspondence	Select if you want this action, when taken, to also cause a final disposition action for batch correspondence.

Examples

Figure 1071 Protocol Action Type Description Value Examples

Common Features

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

Table 733 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.