Page 466 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Com-101
SOP Title: P.A.C.T
g. Inclusion/Exclusion criteria (cohorts, ages, any expected challenges with recruiting?)
h. Number of patients to be screened? Enrolled? Locations (special issues/key personnel)? Where? When? How? Contacts for each performance site?
i. On-study activities. Timing? Length?
j. Involvement of Pharmacy, Laboratory (shipping/storage), x-ray, MRI/CT, ECHO, EKG, other.
k. Weekend, holiday or night coverage
l. Human resource requirements. Roles and their scope, including: expected study knowledge, activities, procedures, expected time input to meet coverage requirements.
m. Study Team Coverage Structure
n. Study Team Communication Chain
i. Expectations for communication within team and outside team (other departments, sponsor, IRB, etc.)
ii. Expectations for problem resolution
iii. Expectations for self-auditing within team.
o. Draft version of Coordinator’s Checklist/Hand Off Tool.
2. Schedule an appointment time and send an Outlook Invite to the study team.
3. Provide study report to potential team members, plan for team and individual priorities and organize meetings to discuss roles and responsibilities.
a. Primary coordinator is the leader of the group (or shared if co-coordinating).
b. Preferred methods of communication should be discussed. How will Primary Coordinator keep team members informed (email, face to face meetings)?
c. Review human resource needs: Primary Coordinator, back-up coordinator, co-coordinator, and support staff. What skills and experience are needed for each role? Openly discuss expectations relating to the specific protocol.
i. Structure of team
ii. Roles/responsibilities (what is needed and who will be responsible for what).
• Local regulatory (IRB/Children’s/PHHS/UTSW, etc.)
• Study manager
• Screening
• Consenting
• Enrolment/Randomization
• Visits
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