These FAQs are related to the completion of the DAIDS Delegation of Duties Log template as outlined in the CRS Personnel Qualifications, Training and Responsibilities section of the DAIDS Site Clinical Operations and Research Essentials (SCORE) manual. Please contact your OCSO PO with any additional questions.
General Questions on the Delegation of Duties (DoD) Log Template
Yes, as long as all the required elements from the DAIDS template DoD log are included.
Yes, the DAIDS DoD template is a word document and includes “fillable” fields. Additional lines may be added.
As long as the dating format is kept consistent to (day/month/year), the form allows you to type it as (DD/MMM/YYYYY) or (DD/MM/YYYY). The site can use either of the two formats as long as it is clear for monitors.
Required elements mean mandated concepts not mandated terminology. In this case, principal investigator and investigator are fine.
Use the full first and last name and ensure the names always appear in the same order. Middle name is not required except when there are 2 people with the same initials. Use the same initials on the DoD log as you would use when initialing source documents.
Questions on Delegation of Roles and Responsibilities
- By definition, delegation of duties is entrusting someone else to do parts of your job. In clinical research, this means investigators can delegate study-related tasks to their staff members to perform on their behalf, but they never relinquish responsibility for those tasks and their outcomes.
- The investigator is responsible for identifying key personnel to be included in the DoD Log. Key personnel can be described as clinical staff who are responsible for the following: study coordination, data collection, data management, recruitment, enrollment, informed consent, and regulatory compliance.
- In this case, list both responsibilities on the DoD log
PPD has reviewed and provided feedback on these FAQs. If the task can be done by a contracted service or done by individuals not specifically designated by the investigator, then they do not need to be listed in the DoD Log.
If the activities are required by the study then and these individuals will be performing the procedure routinely as part of the study, then they need to be listed on the DoD log.
The investigator is responsible for identifying key personnel to be included in the DoD Log. Key personnel can be described as clinical staff who are responsible for the following: study coordination, data collection, data management, recruitment, enrollment, informed consent, and regulatory compliance.
Personnel considered “fee for service” who are in supporting roles such as couriers, drivers, receptionists and administrative staff do not need to be listed on the delegation logs.
Personnel in supportive roles such as couriers, drivers, receptionists, and administrative staff do not need to be listed on the DoD log.
No. The IoR is responsible for the overall conduct of the trial. The IoR documents delegation of specific duties to site personnel using the DoD log. Any duties not delegated remain with the IoR; however, these duties do not need to be documented on the DoD log. The IoR signs the DoD Log and initials next to all tasks that have been delegated.
Questions on Significant Study Duty/Task Key Items
If the responsibility can be done by a contracted service or done by individuals not specifically designated, then they don’t need to be listed in the DoD Log. The investigator is responsible for identifying key personnel to be included in the DoD Log. Key personnel can be described as clinical staff who are responsible for the following: study coordination, data collection, data management, recruitment, enrollment, informed consent, and regulatory compliance. It is important for sites to focus on study-specific responsibilities and the individual’s level of involvement in the research rather than the procedures.
Any clinical staff involved in the assessment must be listed under this category. If the term is confusing or sites prefer different categories, please use the “Other” sections to add more categories.
The term Study Product Management was chosen based on feedback from our external stakeholders. The category is broad to make it easier to include different responsibilities. In this case the term refers to pharmacist/associate pharmacist. If the term is confusing or sites prefer different categories, please use the “Other” sections to add more categories.
It is important for sites to focus on the individual’s level of involvement in the research rather than the procedures. If a study has a specific person designated solely to perform a task for the study that requires special training like a lumbar puncture, then that person must be on the DoD Log. If the procedure is done by a contracted service or done by individuals not specifically designated by the investigator, then they do not need to be listed on the DoD Log.