Applicable “Ongoing” studies
Q: Do I need to use the new DAIDS DoD log template for a registrational trial that is closed to follow-up and the data has been locked or data lock is before 14 June 2019?
Q: My site’s study specific DoD Log has all the elements included in the DAIDS DoD template. Can I continue to use the site’s DoD Log?
A: Yes, for current ongoing studies including ongoing registrational trials IF they contain all the required elements. New studies need to use the DAIDS DoD Log.
Completion of the New DoD Template
Q: Can I modify the DAIDS DoD log?
A: No, the DAIDS DoD log cannot be modified, however, sites may add study tasks using the “other” lines.
Q: Can the DAIDS DoD template be fillable?
A: Yes, the DAIDS DoD template has been modified and includes “fillable” fields.
Q: What happens if we need extra pages?
A: Additional pages for staff and research related duties have been added. These pages can be found in the Division of AIDS Clinical Research Policies and Standard Procedures Documents website: DOD Template (Staff Information Additional Lines Fillable) and DOD Template (Research Related Duties Additional Lines Fillable)
Q: To avoid confusion, can we use the format of DD/MMM/YYYY or is the dating format set as referenced?
A: 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’s clear for monitors.
Q: Which version number do I include on the new DoD log template if transferring data from a prior DoD log?
A: When starting a new DoD log, the previous DoD log should be closed so include a new version in the new DoD log.
Q: I cannot type the title into the document except as a one-line entry, and given the length of our study titles, the document is unreadable if I try to type in the title.
A: The Protocol title line in the DAIDS DoD template has been modified to expand as you write.
Q: I am having a difficult time downloading the DAIDS DoD template.
A: Certain conditions on your computer, such as security settings or browser cookies, can prevent you from correctly downloading a PDF. Often, the fastest solution is to try to open the page using a different browser.
Q: The DAIDS guidance indicates that the DoD Log must include all elements of DAIDS template. Does “all elements” extend to exact wording? For instance, we changed “Investigator” to “Principal Investigator” and also made some language clarifications to the task key.
A: Required elements mean mandated concepts not mandated terminology. In this case, principal investigator and investigator are fine.
Q: DAIDS Delegation of Duties Log Instructions state: “Be sure to keep the numbers in sequential order” on page 1 (2nd bullet, under “General”) and page 4 (line 3). We have re-arranged the tasks in the task key and have re-assigned the numbers so that the numbers are in sequential order. Does “keep[ing] the numbers in sequential order” extend to the tasks themselves? Does DAIDS require the tasks to stay in their original order?
A: The format of the DAIDS Log cannot change. If additional tasks need to be included, use the “other” lines to include additional tasks.
Q: 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”? We want to make sure we are in compliance. Most of our investigators and study staff do not routinely include their middle name in documents. A few of them might, at most, include their middle initial but no more. We are just not sure about how strictly we must interpret “Full Legal Name”, especially if that is not exactly how staff actually sign off on documents.
A: Use the full first and last name. 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.
Delegation of Roles and Responsibilities
Q: What 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?
- A: 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 behalves, 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.
Q: Should the IOR include a driver/s on the DoD log if responsible for specimen transport?
A: Personnel in supportive roles such as couriers, drivers, receptionists, and administrative staff do not need to be listed on the DoD log.
Q: Item 22 on Delegation Log Template - 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?
A: 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 is referring to pharmacist/associate pharmacist. If the term is confusing or sites prefer different categories, please use the “Other” sections to add more categories.
Q: Item #26 on Delegation Log Template. 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?
A: It is important for sites to focus on the individual’s level of involvement in the research instead of the procedures. If a study has a specific person designated to solely perform a task for the study that requires special training like a lumbar puncture, then that person needs to be in the DoD Log. If the procedure is done by a contracted service or done by individuals not specifically designated by the investigator, then they don’t need to be listed in the DoD Log.
Q: Item #11 on Template. 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.
- A: 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 instead of the procedures.
Q: Log Template 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”?
A: Any clinical staff involved in the assessment needs to be listed under this category. If the term is confusing or sites prefer different categories, please use the “Other” sections to add more categories.
Q: 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.
A: 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 don’t need to be listed in the DoD Log.
Q: 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.
A: 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.
Q: 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 1572?
A: 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.
Q: In the past anything considered “fee for service” was not included on the delegation logs. Is that still the expectation? If you are paying them to do it, then it is fee for service.
A: Personnel “fee for service” and who are in supporting roles such as couriers, drivers, receptionists and administrative staff do not need to be listed on the delegation logs.
Transferring Data from the “Old” Form to the New DoD Template
Q: When the site transitions to the DAIDS DoD template, would they indicate an ‘end date’ on the current site DoD log for each delegated task, and include that same date as the ‘start date’ on the DAIDS DoD log?
A: Sites need to close out current DoD log by entering the current date in the end date column. The DAIDS DoD log should be filled out listing current staff and their delegated duty(ies), and be updated, as applicable with new staff delegations; the start date for the current staff delegated duties should be entered with the same date as entered in the old log’s end date.
Q: Per memo, no timelines given to sites with no study specific log for ongoing studies. Should Sites implement DAIDS DoD log using the 90 days / June 14 timeframe.
A: For current studies who have no study specific DoD Log, a DoD log needs to be established as soon as possible using the DAIDS DoD log.