Page 49 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-002 SOP Title: Study Assignments & Productivity
o Interactive Web Response System (IWRS) o ElectronicDataCapture(EDC)
o Badgeaccess,studyrecords&materials
✓ Obtain certificates for all required trainings (e.g., CITI, sponsor-specific) ✓ Obtain signed CV and credentials
✓ Financial Disclosure Forms (FDF)
✓ Delegation log
✓ PACT Meetings, patient information & study visit schedules 6. PROCEDURE PROCESS MAP
D050
Obtain CV /
Grant Accesses Licensure / Certifications /
Training
Obtain Financial Disclosure Form(s)
Update Delegation
of Authority and Conduct PACT to
Upload into Velos integrate to team
Decide the Back-Up
Notify CRC and Backup
7. CHANGE HISTORY
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R003
10/01/20
Added productivity reporting; clarified the collaboration of the team member and team lead in study coverage and productivity reporting
R003
R003
04/01/20
Revised from back-ups coverage only; add study allocation process
D013
R003
04/01/21
Revised from weekly to monthly
R003
R002
08/01/2022
Updates online Monthly Report Process
R003
Page 6 of 6
Team Lead CRC / CRA Start
Finish