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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-002 SOP Title: Study Assignments & Productivity
5.1.3 The team member should be attentive to answer questions and provide information regarding study management and progress.
5.1.3 Each month when the Monthly reports are received from the team, the team leads should enter the data into the CRWT tool sand recalibrate the data reference. Team leads should inquire about any anomalies they identify with their team and then submit the Monthly Report to clinical manager and director for their review (See SOP A009 Monthly Report & CRWT for more information on CRWT analysis).
5.2 When a study is first assigned, it is important that leadership makes an informed decision about who the primary and back-up CRC or CRA will be for that study. In order to make the best decision, it is advised to follow the decision tree presented in Figure 5.1.1.
Figure 5.1.1
PI Prefrence
Workload Assesment
Calibration
Study Allocation Meeting
Is the CRC/A on contract or fully dedicated?
Is the CRC/A a skills match (e.g., infusion nurse)?
Current Workload
Projected Workload
What can be done to reassign study roles or studies to create more bandwidth?
What can be done to prepare additional support to offload future projected workload demands?
Hold study allocation meeting with team to review proposed coverage plans
Incorporate the team's feedback and ideas for how to optimize coverage.
Study Assignment
Submit study coverage plans to director for approval.
Hold PI introductory meeting to develop enrollment plan
Hold PACT with study team to ensure onboarding
5.3 Upon assignment, the primary CRC or CRA should complete the following to successfully onboard the study team onto the study.
✓ Hold PI Introductory meeting
✓ Grant all necessary accesses (include Team Lead as “Other Study Personnel in
eIRB and Velos): o eIRB
o Velos
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