WIRB's Suggested Guidelines for Evaluating Staff Levels at the
Site
WIRB's initial review submission forms
asks for information about staffing levels at the site. WIRB evaluates site staffing
levels based on a variety of criteria.
At a minimum, all clinical sites should have the following:
- Enough trained investigators and staff to administer the protocol without deviations
that impact subject safety or data integrity
- Enough trained investigators and staff to ensure there is sufficient time available
for staff to interact with the subjects as much as is necessary for good clinical
care
- Enough trained investigators and staff to provide coverage for emergencies
In addition, the Board considers what level of staffing would be required to execute
the protocol. For example:
- How many subjects are already enrolled and what is the predicted rate of accrual?
- How many visits are required by the protocol?
- What type of visits are required and will the subject need to see the investigator
at each visit?
- Are the required procedures complex or lengthy?
- Does the administration of the study drug require supervision or extensive instruction?
- Are the subjects generally healthy, seriously ill, or suffering from multiple conditions?
- Is the disease involved acute or unpredictable?
- Are the side effects of the intervention expected to be numerous or serious?
- Are the subjects considered vulnerable?
The particular composition and expertise of the study staff also is a consideration:
- Does the investigator have experience in conducting research? (This variable can
affect overall management of the research staff and functions.)
- Are the staff members experienced in conducting research? Are they skilled at maintaining
accurate and complete study records?
- Do the investigator and staff have experience with the type of treatment in the
protocol?
- Does the site have other ongoing protocols?
For example, the Board might determine that an experienced research coordinator
can administer 3 to 5 drug protocols that require weekly or biweekly visits of ½
hour to 2 hours and enrollment of 5 to 15 subjects. However, if the site's ratio
amounted to 7-10 of these studies per experienced coordinator, the Board might table
the research and recommend the site adjust the staffing levels. The Board would
also expect to see at least one physician sub-investigator appointed to provide
back-up for the principal investigator.
Different types of protocols, however, require different levels of staff time and
expertise. Because of their narrow inclusion criteria, oncology protocols normally
don't rapidly accrue subjects, and because they are often carried out by groups
of oncology specialists, the Board might tolerate a high protocol-to-staff ratio.
In these cases, the Board's focus might shift from the number of staff, to the ability
of a large staff to successfully coordinate a subject's care and execute the study
plan.
In the case of a non-treatment protocol, the question of staff levels may be immaterial.
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