Page 573 - 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
The CRWT algorithm collectively reflects these factors which are ultimately multiplied by the number of total active patients.
This the CRWT score adjusted for the appropriate roles each team member contributes toward the study.
This is a binary entry and additional workload factor. Answer yes to this item if the in-person monitoring happens at a frequency <3months. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the study is an industry or CRO sponsored study. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the study visit intervals happen at a frequency > 6 weeks, or the study visits last > 4 hours. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the study routinely involves > 3 questionnaires in a given study visit. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the study takes place in the inpatient, or non-outpatient setting. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the scoree is precepting someone on the study or is required to be highly engaged with the ancillary staff for purposes of carrying out the study visits. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the scoree is r is required to be highly engaged with the subjects outside of the usual study windows for purposes of carrying out the study visits. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra point in the collective protocol weight that will ultimately get multiplied to the number of active subjects.
This is a binary entry and additional workload factor. Answer yes to this item if the remote monitoring happens at a frequency > 2hours/month. Answering "yes" will generate a "1" on this report and will result in the addition of "1" extra
CRWT modifications (deductions in score) for RA, RC, DM
In-Person Monitoring (Frequency < 3 months)
Industry Sponsor/CRO factor
Duration of treatment or number of follow-up visits
Multiple surveys/Questionnaires
Protocol Mandated In- Patient
Mentoring New Staff
Following Subjects at Satellite
Remote Monitoring (>2 hours/month)
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