Page 575 - 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
Frequently Asked Questions:
1) How do we properly define ‘Research Assistant’ support? Is this field assigned only to coordinators managing the study as primary coordinator? Or, is it assigned to coordinators managing patients only?
(When it applies, Co-Coordinator or RN Support)
2) How is the field ‘duration of treatment or number of follow up visits’ defined? What does ‘duration’ mean specifically? The yes/no option doesn’t seem to make sense in this case; it seems like it should be quantitative value.
Study Duration: Length of study visit (> 4 hours)
# of Study Visits: Once subject is passed screening and on treatment, if study visit intervals occur more frequently than every 6 weeks
3) ‘Mentoring new staff’: is this meant to apply to a brand-new coordinator in training only, or does it also serve to give some merit/weight to training for backup staff as well? Ultimately, what is this field intended for?
Mentoring Staff: Precepting new CRC, educating ancillary team members beyond what would normally be expected.
4) How are both monitoring questions meant to be handled? For example, if we select yes for one of the monitoring fields, what do we do with the other monitoring field? Can both be yes, both be no, select one yes and one no? Please explain the intention here.
Both monitor fields are independent of each other.
In Person Monitoring: Yes, if in person monitoring occurs more frequently than every 12 weeks.
Remote Monitoring: Yes, if remote monitoring occurs longer than 2 hours in duration (a given session) a month.
5) How do we score the ‘other weight’ field properly? What types of action are supposed to be considered/count here? (wide range of actions with varying time commitments: echoes, pKs, questionnaries, etc.) When assigning the numerical value, does each action hold the same value? How do you know what value to assign anything/what increments are appropriate? Are there different point classifications for certain tasks/task groups? What is the value of having such tiny increments? How do we give weight to extra things when they each take different amounts of time? How does that impact score properly, if at all?
The added weight is meant to cover any additional workload factors not already covered by the inventory of the tool. It is added cumulatively with the additional work load factors and CRWT score. For example, duration of visit may cover a PK day (if the PK did not require the CRC come in at night), however, a sleep study or a study required overnight stays would not be covered by this workload factor and would be
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