Page 470 - 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
• Roles/responsibilities (what is needed and who will be responsible for what).
o Localregulatory(IRB/Children’s/PHHS,etc.) o StudyManager
o Screening
o Consenting
o Enrollment/Randomization o Visits
o Labs/Shipping
o Datacollection
o Data entry/CRF completion
o Other
d. Discuss typical work days for team members.
e. Create study training plan for each team member (how, when, where).
f. Structure plan for unexpected absences
g. Define notification method to be used for PTO days (ie: use of the “study
communication tool”)
h. Structure plan to provide feedback for process improvement including
communication – how can we be most effective?
i. Schedule for team meetings (date for “all team members” PACT meeting with
manager).
j. How will team members keep Primary Coordinator informed of activities?
k. Create team contact sheet (how to reach each team member and preferred
method of communication).
Frequently Asked Questions for P.A.C.T. Study Team Members
1. What are the expectations for study knowledge and coverage as I assume backup responsibilities in the absence of the primary coordinator?
It is the back-up coordinator’s responsibility to gain the knowledge required to assume responsibilities of the primary coordinator in various situations such as planned or unexpected absences. This should be discussed during the defining of roles and responsibilities as the P.A.C.T. is formed.
2. What is the plan for study specific training? When and how?
The primary coordinator is responsible for coordinating study specific training.
3. Will the primary coordinator expect back-up only when (s)he is off campus or will I provide additional support daily or periodically? At what level and how often?
This depends on the study and the situation and should be discussed at a P.A.C.T. meeting.
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