Page 468 - eBook Version 8 Book 1 of 2 JUL 2022
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STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-101
SOP Title: P.A.C.T
P.A.C.T. WORKSHEET
P.A.C.T. member’s roles and responsibilities are listed in the chart below. (Use the key to list letters and numbers corresponding to roles/responsibilities). The list below is not intended to be a complete list of all responsibilities, duties, and skills required. Changes must be approved by manager and communicated to team members by primary coordinator.
Team Member
Role(s)
Responsibilities
Initials
Roles
a. Primary Coordinator
b. Back-up Coordinator
c. Co-Coordinator
d. Data Support
e. Research Associate
f. Research RN
g. Research RRT
h. Medical Assistant
i. Other (Specify)
j. PI/Co-PI
Responsibilities
1. IRB/Regulatory/Budget submission/Coordinator binder
2. Screen
3. Enroll/Randomize
4. Consent
5. Source Documentation
6. Complete/enter CRF’s
7. SAE/AE Reporting/Med watch
8. Query resolution
9. Lab Orders
10. Specimen Collection
11. Specimen Processing
12. Vital signs, weight, EKG, etc.
13. Drug Administration
14. Family Education: requiring license
15. Family Education: non-licensed
16. Shipping
17. StudyManager
18. Other (specify)
__________________________ __________________________ _____________________
Manager (Printed) Manager (Signature) Date
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