Delegation of Duties Frequently Asked Questions

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.

1. Can I modify the DAIDS DoD log template?

Yes, as long as all the required elements from the DAIDS template DoD log are included.

2. Can the DAIDS DoD template be fillable?

Yes, the DAIDS DoD template is a word document and includes “fillable” fields. Additional lines may be added.

3. To avoid confusion, can we use the format of DD/MMM/YYYY or is the dating format set as referenced?

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.

4. The DAIDS guidance indicates that the DoD Log must include all elements of the DAIDS template. Does “all elements” extend to exact wording? For instance, we changed “Investigator” to “Principal Investigator” and made some language clarifications to the task key.

Required elements mean mandated concepts not mandated terminology. In this case, principal investigator and investigator are fine.

5. Header for the site staff names section says, “Site Staff Full Legal Name”. What is meant by “Full Legal Name”? Does it mean we need to spell out middle names? Or is it more about, for instance, someone named “Susan” should not write their name as “Sue” or “Susie”?

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.

6. Which study roles should be listed? Should all roles be included, or do certain roles supersede others? Ex. for a nurse that is a study coordinator and sub-investigator, should both or only one be listed?

  • 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

7. Are DAIDS and the PPD monitors on the same page with the sites as to what is considered ancillary services versus duties performed by study staff? Sites may have an interpretation of what needs to be added to the delegation logs.

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.

8. The protocol is asking for participants to be linked to ancillary clinic staff to discuss adherence, compliance, etc. Are those individuals going to fall under the “ancillary staff exemption”? They will be providing care and supportive services that they are trained to do, and they work with this population on a regular basis. They are not providing “research” duties per se. However, the activities they will be performing will be required per the study.

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.

9. What about sites not associated within a clinic that will have to find staff to perform these duties? Do these need to be included on the DoD log? Will DAIDS clarify who are the essential individuals that need to be on the delegation logs for this type of situation? Is this just CRS staff listed on the FDA Form 1572?

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.

10. In the past anything considered “fee for service” was not included on the delegation logs. Is that still the expectation? If you are paying personnel to do it, then it is fee for service.

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.

11. Should the IOR include a driver/s on the DoD log if responsible for specimen transport?

Personnel in supportive roles such as couriers, drivers, receptionists, and administrative staff do not need to be listed on the DoD log.

12. Item 11 - Lab/Sample Collection. Do you mean phlebotomy by collection? Phlebotomy is a contracted service at many sites and the phlebotomist is not on our current delegation logs.

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.

13. Item 21 – Assess AEs/SAEs/EAEs. One site states the research nurse does the initial assessment. The investigator then determines causality. What exactly is meant by “assess”?

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.

14. Item 22 - Study Product Management. What exactly does “management” mean? Does this just apply to the pharmacist? Does this also include the study coordinator receiving returned drug from the subject?

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.

15. Item 26 - Leukapheresis is added as a study-specific procedure rather than a contract procedure. Leukapheresis is a contracted service at many sites. Per the note at the top of Page 4 of the template, ancillary clinical staff with only an occasional role in the conduct of the research do not need to be included on the delegation log. How do sites justify what this is a contracted service that is not performed by study staff?

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

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