Help Topics - DTL Site Guide

The Delegation of Tasks Log (DTL) Site DTL Help Page

Site DTL Browser Overview

The Site DTL Browser is visible to all user types and is accessed from the Site DTL Browser link along the menu bar or the View/Manage Single DTL Quick Link within the site Dashboard (site users only). It allows you to view all DTLs for your affiliated sites and organizations.

Available information on each DTL includes:

Site – CTEP site code
LPO – Lead Protocol Organization for the protocol
Protocol
Protocol Status
DTL Status (More Info) - the default setting includes all statuses except Retired. If there is a status reason associated with the status (e.g., reasons why a DTL is Unapproved), you can click on the hyperlinked status to see the status reason(s) in a popup
Status Date – date on which the site DTL reached its current status
Last Clinical Investigator (CI) Approval Date – the date the CI last signed the site DTL; will be blank if not yet signed
Clinical Investigator – the CI named on the Site DTL (any task status except Inactive) regardless of the DTL Status
Updated Date – the date the latest update of any kind was made to the site DTL, whether by a user or by the system
Updated By – the individual who made the last update (can be System)
Actions – the icons that appear will depend upon the status of the DTL, your user type (site, NCI, LPO, etc.), and your task assignments (i.e., whether you are a DTL Administrator (DTLA) or CI for a given site DTL)

All columns in the browser are sortable by clicking on the column header. You may also filter for available DTLs using the filter fields for all the column headings (except for the Actions column). Once you have set your filters use the Apply Filters button just below the filter fields. Use the Reset Filters link to reset (i.e., clear) all the filters and return them to their default state.

Outside of the browser grid, there are five additional functions available; some are only visible to site users.

A toggle allows you to view only DTLs where there are patients enrolled to that study/site combination.
A View control allows you to view all possible site DTLs or site DTLs where you are the DTLA, the CI, or are assigned any tasks. This control is visible for site users only.
The Initiate Site DTL button allows you to create a new site DTL (see Initiating and Cloning Site DTLs for more information). This button is visible for site users only.
The Filter icon allows you to show/hide the filters within the browser table.
The Export icon allows you to export the current contents of the browser display table to Excel. The export includes additional columns that are not visible in the grid, i.e., Status Reason, CI CTEP ID, and Template Revision.

Figure 1: Site DTL Browser.

Action icons will appear in the Action column of the Site DTL Browser depending on the user type, and for site users, whether you are assigned the CI or DTLA task. The visible action icons also depend on the status of the given site DTL. Of note, all users can view and use the View DTL Audit History Audit History icon on Site DTL Browser icon, the Generate DTL Summary Report DTL Summary Report icon icon, and the View DTL View DTL icon icon for each site DTL. The i buttons next to the Site, Protocol, Updated By, and Clinical Investigator provide additional information on the institution, protocol, Clinical Investigator, and person, respectively.

See the legend at the bottom of the Site DTL screen for more information about the different icons used in the Site DTL Browser.

DTL and Task Audit History

You can view the audit history for an entire DTL or for an individual task.

You can access an individual site DTL’s audit history from multiple screens, including the Site DTL Browser and the Manage Site DTL screen via the History Icon to view DTL audit history icon (see Figure 2).

Figure 2: Site DTL Browser - Audit History Icon.

When selected at the DTL level (vs. task level), the default view is the DTL Audit History (see Figure 3).

The most recent action displays at the top of the list.
The history includes the date of the DTL action, the user who made the update (may be the System), the update itself, and the starting and finished states showing the change from the previous DTL status to the current DTL status.
You may also view status changes in a specified data range using the Set Date Range date picker controls above the table.
For Approved DTLs, you may select the PDF icon in the Action column to view or print the signed DTL form.
The Filter icon allows you to show/hide the filters within the audit history table.

Figure 3: DTL Audit History.

You can view a task’s assignment history via the Task Assignment Browser (see Figure 4), the Manage Site DTL screen, or by selecting to view the history By Task at the top of the DTL Audit History screen.

Figure 4: Task Assignment History Icon.

The Task Assignment History displays information on the action date, the user who made the update, the task assigned and the assignee, and the starting and finished states (see Figure 5).

Figure 5: Task Assignment History.

DTL and Task Status Definitions and Status Reasons

DTL Status Definitions

Initiated: The site DTL has been started but has not been submitted for Clinical Investigator (CI) sign-off. Note: you may save DTLs with partial assignments in this status. You may also permanently delete a DTL in this status as long as the last Updated By is an individual, not System.
Awaiting CI Approval: The site DTL is complete and has been submitted to the CI for sign-off but has not yet been signed. If necessary, the CI or a DTL Administrator (DTLA) may revert a DTL from this status back to Initiated status.
Unapproved: The last person assigned a mandatory or required task is no longer active or failed another required check, or the DTL is past its annual signature date.
Approved: All required tasks are assigned, and the CI has signed the DTL.
Retiring: The DTL version is about to be retired due to the release of a new DTL template version. Once a site DTL enters this state, a new site DTL is automatically initiated using the new DTL template version. No changes can be made to a DTL in this status.
Retired: The DTL version is no longer active due to the release of a new DTL template version (and the grace period for obtaining approval for the new version at the site level has passed), the site has a withdrawn site registration status, or the study has gone to a FDAAA/IRB Completed status (shows as a complete site registration status).

Task Status Definitions

Active: The assignee has an active CTEP status, active roster status on a participating roster at the site (required for most tasks), appropriate CTEP registration type, and has completed any required task training. Note that once a site DTL has been signed, tasks that do not require CI sign-off can become active immediately upon assignment.
Pending: The assignee has a suspended CTEP status, is suspended on all participating site rosters, does not have the associated role on the site roster (when applicable), or has not completed required task training. The reason(s) for a Pending task status will display in the Status Reason column.
Awaiting CI Approval: The task assignment requires CI sign-off and does not have outstanding task status reasons. In a DTL that has never been signed, all approvable task assignments will have this status.
Inactive: The assignee has a CTEP status of other than active or suspended, is withdrawn from all participating rosters, no longer holds the appropriate CTEP registration level, or was manually inactivated by the DTLA or CI.

Summary of Status Reasons at the DTL and Task Level

Table 1: DTL Status Reasons
DTL Status Reason	What to Do
Some Required Tasks are not Active.	Ensure all required tasks are assigned and approvable; ensure the site DTL is approved/signed by the CI.
Some Required Tasks are not Assigned.	Ensure all required tasks are assigned and approvable.
Template Associated with this DTL is Retiring.	Locate the site DTL for this site/study that has been initiated on the new template version and make all updates there.
Missing Task Assignment/Signature for Primary Task.	Ensure that the CI and DTLA tasks have been assigned and are ready for approval/signature.

Table 2: Task Status Reasons
Task Assignment Status Reason	What to Do
CTEP Registration Status is other than Active.	The individual must re-register through the Registration and Credential Repository (RCR) (if an Investigator [IVR], Non-Physician Investigator [NPIVR], or Associate Plus [AP]) or through CTEP-IAM (if an Associate).
CTEP Registration Type is not allowed to perform this task.	The individual must re-register through the RCR with a registration type required for the task or somebody else with the appropriate registration task must be assigned to the task.
Member role status is not Active or Follow-up status.	The individual must be at the site on a participating roster. The primary contact at the site for the roster owner can add the individual to the site in the Roster Update Management System (RUMS), or, in the case of an NCORP, in NCORP-SYS.
IRB number for the CI is not valid.	Update the IRB number in the CI’s RCR profile to include the IRB number associated with the site’s IRB approval for the study.
The IRB number on the person’s 1572 does not match the site’s IRB.	For the CI, Enrolling Person/Treating Investigator, and Consenting Person tasks, the individual must put the IRB number associated with the IRB approval in their RCR profile before these tasks can be active.
No IRB approval on file for this site.	This will appear in the rows for the CI, Enrolling Person/Treating Investigator, and Consenting Person tasks. Submit the IRB approval to the CTSU Regulatory Office (for sites using a local IRB) or complete the Study-Specific Worksheet in IRBManager (for sites using the CIRB). You can build a DTL with this status reason in place, but it must be resolved prior to submitting for CI approval.
Required training not complete.	Complete the required training assignment(s) in the Compliance, Learning, and SOP Solutions (CLASS) system.
This task requires the assignee to have the corresponding institutional level role.	This message typically applies to the OPEN and Rave-related tasks, in which case, assign the individual the appropriate role(s) at the site in RUMS to activate the task.
Minimum number of assignments not met for this task.	Assign additional qualified staff to the task.

DTL Notification Emails

The email notifications associated with the DTL application are described in Table 3.

Table 3: Email Notifications
Email	Generated By	Goes To	Trigger
Bi-monthly CI Signing Notification	The system (automatic)	CI and DTLA(s)	Sent on the 1st and 15th of every month and includes all DTLs that require CI sign-off. Subject line: Bi-monthly CI Signing Notification
On Demand Email Notification	DTLA	CI and DTLA(s)	DTLA generates an email to alert the CI of an urgent request to sign an individual DTL. Subject line: DTL for [study #] at [site #] is Ready for CI Approval
Unapproved DTL	The system (automatic)	CI and DTLA(s)	Sent when a DTL goes from an Approved to an Unapproved status. Subject line: Unapproved DTL for [study #] at site [site #]
New DTL Template	The system (automatic)	CI and DTLA(s)	Sent when a new version of a DTL is released and the existing site DTL goes to a Retiring status. Subject line: New DTL Template for [study #] at [site #]
Summary of Signed DTLs	The system (automatic) based on subscription	Subscribed DTLA(s)	CTSU Report and Subscription Portal (CRISP) notification that provides an alert to the DTLA when a DTL has been signed. Can be sent daily, weekly, or monthly. Subject line: CRISP [Frequency] Notification - Summary of Recently Signed DTL(s)

Note the following:

These email notifications go to the DTL-specific Clinical Investigator (CI) and DTL Administrators (DTLAs) whose task assignments are in any status except Inactive.
These email notifications go to the email address on file within each user’s CTEP/Registration Credential Repository (RCR) account. If you believe you are not receiving DTL-related emails that you should, check your CTEP account to ensure your email address is correct; also check your spam folder.
Many institutional email systems strip active hyperlinks from external emails. If a direct hyperlink within a DTL notification email does not work, follow the instructions within the email for an alternative way to access the DTL.

Post Date: xx-Feb-2025