Page 46 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-002 SOP Title: Study Assignments & Productivity
and skills, as well as service line preferences. Therefore, it is crucial that the team member’s complete a Monthly Report and the team leads complete the CRWT analysis of the existing and new studies or portfolio’s and feasibility assessments of the portfolio for new studies.
Team Member’s Responsibilities
All CRCs and CRAs are to communicate anticipated or emergent coverage needs with as much notice as can be afforded to their team leads. Additionally, for their existing portfolios, it is asked that team members are to complete a Monthly Report of their study progress. Their Monthly Report is due by the fourth business day of each month on their respective Share Point reports. Each CRC and CRA is expected to provide the following in their Monthly report for each study for which they take an active role:
• Study IRB Number
• Total Number of Patients Enrolled on the Study
• Total Number Expected to be Enrolled on the Study
• Total Active Patients on the Study
• Total Patients on Follow-up
• Total patients enrolled this month
• Total Number of Patients Screened
• Date of Last Contact with the PI
Team Leads Responsibilities
Each month the team leads receive their team’s Monthly reports. The expectation is that the team leads enter the data from each Monthly report into the Monthly Report spreadsheet and then recalibrate the data reference for each dashboard including the RA Study Descriptives Dashboard for a portrayal of RA productivity. Once the data entry and calibration has been completed, the CRWT report is sent to the clinical manager and director.
Prior to submission of the Monthly Report to the director, the team leads should review the report to identify anomalies including out of range or inconsistent data points. If anomalies are identified, the team leads should seek more information to the responsible team member. Following submission of the report, the team leads should be attentive to answer questions regarding any aspect of the report to clarify or explain contributing people or process dynamics from the clinical manager and director. Suggestions for making changes to the data collected from the team members on the Monthly reports, identifying if retraining is needed, and providing a supporting report with the Monthly Report data are expected to be addressed by the team leads and are guided by the direction of clinical manager and director.
Following a thorough review of the CRWT and discussion with higher management about the workload analysis and information gathered from meetings with the study team to understand the people and process dynamics, collective decisions are made in regarding study assignments, as well as the distribution of support for particular responsibilities on each study (e.g., screening, regulatory, etc). The team leads
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