Can you identify any other clinical trial protocol elements, not currently listed, that could have an impact on the workload of clinical trial staff at an investigative site?

Review: NCI Trial Complexity Elements & Scoring Model
This model was developed to identify common components of a clinical trial protocol that could, depending on their complexity, impact the workload of clinical trial personnel, which could impact the resource costs at the clinical site. Familiarize yourself with the trial elements and how each scoring level (i.e. standard, moderate, and high) is defined for each element.
Respond to the following questions:
Can you identify any other clinical trial protocol elements, not currently listed, that could have an impact on the workload of clinical trial staff at an investigative site? Justify your answer.
Should consideration also be given to the level of skill, knowledge, and experience of the clinical trial personnel (e.g. Investigator, Clinical Research Associate, Research Nurse, etc.) at an investigative site? Explain your answer.
Should this scoring model be used to assess elements of clinical trial complexity more than once during the conduct of the clinical trial? Why or why not?