The Protocol Action Type maintenance document is used to maintain existing protocol 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.
The Protocol Action Type maintenance table provides multiple controls associated to protocol actions. Flags associated to each protocol action determines whether the protocol action will trigger a correspondence letter, will be used as a final action for batch correspondence and if it will trigger a submission action.
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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. |

Figure 1910 Protocol Action Type Maintenance Document Example Layout
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 861 Protocol Action Type Maintenance Document - Edit Protocol Action Type Section Field Descriptions
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Field |
Description |
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Protocol Action Type Code |
Type a numeric value to uniquely represent the protocol action type in the system table record.
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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.) |
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Trigger Submission |
Select if you want this action, when taken, to also cause a submission action to occur. |
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Trigger Correspondence |
Select if you want this action, when taken, to also cause a correspondence letter to be generated. |
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Final Action for Batch Correspondence |
Select if you want this action, when taken, to also cause a final disposition action for batch correspondence.
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Figure 1911 Protocol Action Type Description Value Examples
Figure 1912 Protocol Action Type and Trigger Submission, Trigger Correspondence and Final Action for Batch Correspondence flags.
This maintenance document includes the following features that are common to most KC maintenance documents:
Table 862 Links to Common Maintenance Document Component Instructions
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Common Maintenance E-Doc Component |
Cross-Reference Links To Usage Instructions |
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Document Header |
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Document Overview Section |
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Notes and Attachments Section |
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Ad Hoc Recipients Section |
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Route Log Section |
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Action Buttons |
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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” in the Overview section. |