Page 576 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Adm-003
SOP Title: Measuring Productivity: Monthly Report
given a weight of 1 as it is comparable to what constitutes a 1 vs. 0 on the other workload inventory factors. Some other examples:
• Completing a quality review for the study: .20 increment for each quality review completed in a given week.
• Subject populations that require additional accommodations that fall to a the CRC (not ancillary staff) .20 increment for each additional workload accommodation
• CRC having to travel to Plano or another remote location an increment of .5 may be added as additional weight.
• CRC having intensive redacting, transmittal and data entry .20 increment for each additional workload factor (e.g., imaging, neuropsyc battery) beyond what would normally be expected or covered by the workload factor of “Multiple questionnaires”
6) What is ‘study stage weight’? Are things like study startup, whether the study is open to enrollment, closed to enrollment but has active patients vs active patients and follow-up patients vs only follow-up patients, etc. taken into consideration here (or elsewhere)?
Study Stage weight: is the status of the study:
• .25 is study start-up (study is not active and enrolling)
• 1.0 is active and enrolling (screening and recruitment are onboard)
• .5 is F/U on actively enrolled subjects (screening and recruitment are not
longer in effect)
7) What does ‘withdrawn’ mean for purposes of this tool? Patients completely off study because they have completed all protocol requirements? Patients who have verbally withdrawn their consent or moved to a different institution? Patients who have completed therapy but are still being followed on study for the purposes of submitting long-term follow-up data? Please explain.
Columns “Y, Z, and AA” (Y (active subjects) = Y – (Z + AA)) determine the # of active subjects that will be multiplied toward the CRWT multiplier to determine the workload for that CRC. Therefore, it is important that you manipulate these field to give the appropriate credit to the CRC who is responsible or completing the workload for X number of subjects.
• Y (total number of subjects enrolled) is the total number of subjects enrolled.
• Z (total # of subjects completed/withdrawn) is the number of subjects you
want to subtract from Y in conjunction with AA to equal the total number of subject that CRC is covering on the study.
i. Withdrawn can be for any reason the subject is no longer on the study
ii. Completed can be for any reason (including that some of the total sum
of subjects enrolled are covered by another CRC)
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