Page 469 - 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
P.A.C.T. Guidance
This guide is meant as a tool to help Research Coordinators and study team members form an effective P.A.C.T. (Professional Accountable Coordinated Team). Use of this guide is meant to be individualized to the study the P.A.C.T. will be supporting and the team. Checklists and other appropriate local study documents may be developed based on which guidance makes most sense for the individual study. All studies will need some of the items listed, but only some studies will need all. You are encouraged to develop your own additions to this guide and to expand and contract it as appropriate.
Forming an effective PACT from a Primary (Co) Coordinator’s Standpoint
1. Put together a study report of information about the study such as:
a. PI/ Sponsor/CRO/Industry vs. Investigator Initiated
b. Type of study
• Inpatient and/or Outpatient
• Observational vs. Treatment
• Safety/Efficacy
• Randomization, Stratification, etc. • CRF system, training
• Expected study start date
c. Inclusion/Exclusion criteria (cohorts, ages, any expected challenges with recruiting?)
d. Number of patients to be screened? Enrolled? Locations (special issues/key personnel)? Where? When? How?
e. On-Study activities. Timing? Length?
f. Involvement of Pharmacy, Laboratory (shipping/storage), x-ray, MRI/CT,
ECHO, EKG, other.
g. Weekend, holiday or night coverage
h. Human resource requirements. Roles and their scope, including: expected
study knowledge, activities, procedures, expected time input to meet coverage
requirements.
i. Draft version of Coordinator’s Checklist/Hand Off Tool.
j. Study Team Coverage Structure
k. Study Team Communication Chain
• Expectations for communication within team and outside team (other departments, sponsor, IRB, etc.)
• Expectations for problem resolution
• Expectations for self-auditing within team
2. 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?
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.
• Structure of team
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