PSC Column: Cancer: DTL Overview

09/12/2024

Written by Belinda Buehl, Regulatory Coordinator, University of Wisconsin Hospital and Clinics, Department of Human Oncology -Radiation Oncology

The DTL or Delegation of Tasks Log application within the CTSU is utilized to document the delegation of tasks for the study team. The site-level Clinical Investigator or CI delegates the tasks to the appropriately trained team members at the site for individual studies. Delegated tasks can vary per protocol. Signed/approved DTLs are required to obtain site registration approval. Without a signed DTL, sites cannot enroll subjects via the Oncology Patient Enrollment Network (OPEN).

DTLs are utilized to ensure site CIs delegate appropriate study related tasks to study team members, improve the ability to track study-specific training for study team members, ensure tasks are delegated prior to study enrollment, and to provide a complete list and history of study team members who contribute to the clinical data for each study. The DTL application interfaces with the Regulatory Support System (RSS), OPEN, and Medidata Rave.

A quick overview of the DTL process is as follows: The LPO (Lead Protocol Organization) creates and maintains the DTL templates. Clinical site staff are assigned access depending on their role to view, create, maintain and approve the study site DTLs.

It is very important for study integrity for the DTLs to be properly maintained. This has been a challenge for clinical sites and has been noted to be a recurring finding during the auditing process by the NRG Oncology Audit team. A major deficiency may be found at the time of audit if study-related tasks are performed by staff who are not on the DTL, performing tasks not assigned to the individual, for allowing the annual renewal to lapse, or if tasks are performed while a DTL is not approved.

The most common deficiencies are approval/renewal gaps and or missing approvals, and inactive DTLs.

Approval/Renewal Gaps and Missing approvals:

DTLs must be signed by the CI and approved prior to site registration approval for newly activated studies.Sites have 60 days to complete DTLs in order to have an approved registration status for studies where the DTL was released after activation or if an updated version of a DTL is available. DTLs need to be approved prior to the performance of any study related activities.

Expired DTLs are a common finding during the audit process. CIs are required to re-sign DTLs by the one year anniversary of the last signing. Reminders should be sent out automatically at 30 days, 14 days and 1 day prior to the renewal date.

Automatic system notifications regarding approvals and renewals are sent to the CI and DTLA (DTL Administrator) for the specific DTL when there is a DTL is ready for approval, but there can be problems receiving the notifications. The notifications are sent to the email address on file within the Registration Credential Repository (RCR) system.If that email is incorrect the notifications will not be received. Another helpful tip is to ensure CIs know to check the spam folder. Unfortunately, automatic notifications are commonly routed to the spam folder, so it is important to encourage CIs to regularly check for email notificationsDTLAs can also generate emails outside of the automatic system notifications to remind CIs to sign or renew DTLs.

Blank DTLs

With the newest update to the DTL application – it has been noted by auditors that the DTL will appear blank if it has not been signed. This can be a problem because on the initiator side, it may appear that the DTL is filled out, but many sites mistakenly think that as long as the DTL is filled out with tasks listed, then they can begin to perform study related activities. This is not the case, the tasks must be assigned and approved by the CI before initiating any study related activities. If the auditor is trying to review the DTL and it is not signed, it could appear blank to them, and it would seem like no tasks have been assigned or approved. Performing tasks without an approved DTL is a major deficiency.

Inactivated DTLs

If the RCR registration is suspended for anyone on the DTL, an end date will show up and the DTL will change to unapproved, and the status will be set to Pending.In this case, the study team member with the expired RCR will need to be removed and then reactivated once they have renewed their RCR. This can cause a problem during an audit if it is not known that an RCR has expired. If the DTL is set to pending it needs to be re-signed and reactivated by the CI in order to be accepted, major deficiencies can occur if the status has reverted back to pending.

A good tip for sites who struggle with any of these findings would be to create a DTL tracker internally that is checked at minimum monthly. When it is 30 days prior to renewal for a DTL it can be helpful to add reminders in a personal calendar or set up auto-reminders. DTLAs, or other assigned team members can personally email the CIs to ensure they are aware ahead of time when a renewal is required. This way sites can plan around possible time off and hopefully ensure the DTLs are renewed timely. Smartsheets are a great option for creating internal trackers for sites. Smartsheets can be personalized to fit the site and can be shared so multiple team members have the ability to update the trackerAnother great resource to troubleshoot common issues with DTLs is on the CTSU website – A Compiled DTL Site Guide is available with many useful topics to assist with the maintenance of DTLs.

Hopefully this overview of the importance of DTLs and discussion of common findings will be helpful to encourage sites to create personalized trackers to help avoid findings at future audits.