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.

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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 2040 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 1056 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. 

tip.png  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review not required, Data Analysis Only, Re-open Enrollment, Closed (Administratively closed), Terminated, Suspended, Withdrawn, Disapproved, Expired, Suspended by DSMB, and Record Committee Decision.)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 2041 Protocol Action Type Description Value Examples

Common Features

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

Table 1057 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” on page Error! Bookmark not defined. in E-Doc Fundamentals.

Document Overview Section

link.png  For more information, see “Document Overview” on page 94 in Common E-Doc Tabbed Sections.

Notes and Attachments Section

link.png  For more information, see “Notes and Attachments” on page 95 in Common E-Doc Tabbed Sections.

Ad Hoc Recipients Section

link.png  For more information, see “Ad Hoc Recipients” on page 97 in Common E-Doc Tabbed Sections.

Route Log Section

link.png  For more information, see “Route Log” on page 98 in Common E-Doc Tabbed Sections.

Action Buttons

link.png  For more information, see  “Action Buttons” on page 71 in Selection, Entry and Action Tools.

Process

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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 Error! Bookmark not defined. in the Overview section.