Page 47 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-002 SOP Title: Study Assignments & Productivity
carryout these decisions with their teams and track the progress and outcomes of these decisions in subsequent CRWT.
4.2 Once, the coverage plan has been assigned, the primary CRC or CRA is responsible for acquiring and granting the required accesses (i.e., IRB, Velos, EDC, IWRS, study records and materials, etc.) and training to the back-up. The team lead should be included in Velos and eIRB as “Other Study Personnel”. The back-up CRC or CRA should be included in the PACT meetings and be fully informed of the study status, patient status, and schedule of study visits. These functions are defined along with other necessary information in the study hand-off, transition & coverage facilitation form, which is expected to be kept updated and in available to the team lead and in the front pocket of the coordinator manual for the study. Both the primary and back-up should have a reliable means of communicating the study needs and coverage.
5. SPECIFIC PROCEDURE
5.1 Each month by noon on Friday the CRCs and CRAs are asked to turn in their Monthly Report for progress on each of the studies for which they play an active role to their team lead. An entry is made in a separate row in their Monthly report for each study they take part. Though each column represents a necessary element for the study review, the two middle columns; 1) total ACTIVE patients on the study, and 2) total FOLLOW-UP patients highlighted in grey, are important for computing the CRWT- based study workload for each study. Please, see Table 5.1 for a display of the Monthly Report completed by the study team.
Table 5.1 Team Monthly report
5.1.1 The team member should complete the Monthly report comprised of 8 columns for each study they take part.
5.1.2 The team member should send the form to their team lead by noon each Friday.
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