Delegation of Task Log (DTL) Master Task List

Delegation of Task Log (DTL) Master Task List
Task Name Primary Task Required Task Allowed Registration Types
(Protocol Dependent)		 Site Roster Requirement Clinical Investigator (CI) Signature Requirement Min Max Associated with Institutional Role Validation Type Task Description
Clinical Investigator (CI) Yes Yes IVR, NPIVR
(for DCP studies)		 Yes Yes 1 1 No System Investigator at the site responsible for signing the DTL for a given protocol and with overall responsibility for the study conduct at the site.
DTL Administrator (DTLA) Yes Yes IVR, NPIVR, AP Yes Yes 1 3 No System Person assigned by the CI to manage the DTL.
Authorized User Prescribing No No IVR No
No roster requirement at the enrolling site, but person must be claimed at a TRF Provider that is linked to the enrolling site		 Yes 1 NA No System, Audit Investigator at the site responsible for writing a patient order for a CTEP IND radiopharmaceutical as a licensed Authorized User for the radioisotope in a licensed facility for the radioisotope.
Authorized User Drug Mailing No No IVR, NPIVR, AP No
No roster requirement at the enrolling site, but person must be claimed at a TRF Provider that is linked to the enrolling site		 Yes 2 NA No System, Audit Individual at the site responsible for receiving, storing, and dispensing a CTEP IND radiopharmaceutical as a licensed, trained, or qualified Authorized User or handler for the radioisotope in a licensed facility for the radioisotope.
Authorized User for Medical Use No No IVR, NPIVR, AP No
No roster requirement at the enrolling site, but person must be claimed at a TRF Provider that is linked to the enrolling site		 Yes NA NA No System, Audit Individual at the site licensed as an Authorized User for medical use of the radioisotope in a licensed facility for the radioisotope for a CTEP IND radiopharmaceutical.
Consenting Person No Yes IVR, NPIVR, AP Yes Yes 1 NA No System, Audit Person listed in OPEN as having responsibility for consent.
Eligibility Assessments No Yes IVR, NPIVR Yes Yes 1 NA No Audit Individual responsible for verification of eligibility.
End Point Assessment No Yes IVR, NPIVR Yes Yes 1 NA No Audit Individual responsible for assessing study end points.
Enrolling Person/Treating Investigator No Yes IVR, NPIVR
(for DCP studies)		 Yes Yes 1 NA No System Investigator listed in OPEN as having responsibility for subject treatment (aka, Enrolling Investigator).
History and Physical (H&P) Assessments No Yes IVR, NPIVR Yes No 1 NA No Audit Individual responsible for conducting physical exams and assessments.
IND Prescribing No Yes IVR, NPIVR Yes Yes NA NA No Audit Individual responsible for writing patient treatment orders for IND agents.
Investigational Product Accountability No Yes IVR, NPIVR, AP, A No No 1 NA No Audit Individual responsible for tracking receipt, distribution, dispensing, and final disposition of study-provided agents.
OPEN Registrar No Yes IVR, NPIVR, AP Yes No 1 NA Registrar System Provides OPEN registration write access to the individual responsible for enrolling patients in OPEN.
Pathology Lab Support No No IVR, NPIVR, AP, A No No NA NA No Audit Pathology lab support.
Patient Screening/Recruiting No No IVR, NPIVR, AP Yes No NA NA No Audit Responsible for screening and recruiting subjects.
Primary Study/Site Contact No No IVR, NPIVR, AP Yes No NA NA No Audit The point of contact for the study.
Rave CRA No Yes IVR, NPIVR, AP Yes No 1 NA Rave CRA System Provides Rave write access to the individuals responsible for data management activities within Rave.
Rave Investigator No No IVR, NPIVR Yes Yes NA NA Site Investigator System Investigator assigned to sign off on the CRFs in Rave.
Regulatory Contact No No IVR, NPIVR, AP No No NA NA No Audit Site staff responsible for regulatory submissions and maintaining essential documents.
RT/Imaging Support No No IVR, NPIVR, AP, A No No NA NA No Audit RT/imaging support (primarily TRIAD-related, but could be other).
Source Documentation Completion No No IVR, NPIVR, AP Yes No NA NA No Audit Responsible for collecting data on study-related assessments.
Study-Related Interventions No No IVR, NPIVR, AP, A No No NA NA No Audit Responsible for coordinating and/or administering study-related interventions and procedures.
Toxicity Assessment No Yes IVR, NPIVR Yes Yes 1 NA No Audit Responsible for assessing adverse events.
Unblinded Study Personnel No No IVR, NPIVR, AP Yes Yes 2 NA No System Study personnel responsible for handling, preparing, and labeling study agents to ensure blinded study randomization is protected at the site. Must have a signed Pharmacy Agreement on file. At a minimum, one of the listed personnel must be the Shipping Designee at the drug shipment site.

*A=Associate; AP=Associate Plus; IVR=Investigator; NPIVR=Non-Physician Investigator



Post Date: 29-Dec-2023