Page 194 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration Department SOP No: R-Reg-103 SOP Title: Creating Study Logs
5.3 Delegation of Authority Log (DOA): The delegation log is important for defining the study team, each study team member’s role, and each of their delegated tasks. The PI is responsible for the entire study, unless a study team member is assigned a study role and the appropriate study tasks for their role on the DOA. The study team member will be responsible for their role and the delegated tasks that the PI delegates to them on the DOA, under the oversight and authority of the PI.
GCP requires that any person taking part in the study be defined on the 1572, approved by the IRB, and documented on the DOA. In order that a person can take part in the delegated role and tasks, they must have the appropriate qualifications and training. As such, the DOA is important for keeping track of all study team members involved on the study, so that the study team, the study team member roles, and study tasks are well defined. Also, the sponsor and regulatory agencies can refer to the DOA in order to ensure that only delegated individuals are participating in the conduct of the research and that each participating team member’s qualifications and study specific training are confirmed, completed, and properly documented in the essential study files in the regulatory binder.
Where there is no mandatory outline of the DOA, it is important to list the protocol title, protocol number, site name/number, PI name, and sponsor name in the header of each page of the DOA. Also, the page number in the sequence of pages included in the DOA is typically seen in the footer of the DOA. Additionally, the team member’s name, signature, initials, start date, end date, role, and study tasks are displayed as columns in the DOA with the PI initials and date in the far right column. Please, see the example below for reference.
It is important that the start date reflect the date when the study coordinator has confirmed and documented the qualifications and training (i.e., credentials, curriculum vitae, license, GCP training, conflict of interest, and study-specific, required training, and IRB approval) for the study team member. The PI should initial and date prior to the team member’s involvement in the study. Also, it is important to enter the end date as the day that the team member ceased all involvement and responsibility for their role and delegated tasks. The PI will provide their full signature and date once the study is completed, closed, or terminated. Additionally, an index should be provided at the bottom of the log to define the study tasks. Please, see the example below for reference.
The study coordinator is required to keep this log up-to-date with the current study team members and their assigned tasks. The latest version of the log is to be uploaded into VELOS for IDS to view delegation authority of the member responsible for drug dispensing.
When submitting a Performance Site Review, the Study Team form required for completion of study submission via UTSW IRB (see SOP Study Submission) may serve dually as the DOA.
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