Audit Preparation Checklist

PNGIMR / Case Western Reserve University Audit Preparation Checklist

PRINCIPAL INVESTIGATOR’S NAME

Peter A. Zimmerman, PhD

INSTITUTION NAME

Case Western Reserve University

STUDY NAME / PROTOCOL NO.

Susceptibility to Plasmodium vivax Infection and Malaria during Early Childhood / DMID Protocol No. 02-004

1. Ensure that arrangements have been made for the audit □ Conference room is arranged/reserved

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Appropriate personnel have been notified and are available All requested materials are available The investigator will be available to meet with the auditors

2. Ensure that the following materials have been checked and are ready for audit:

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Copies of signed informed consent forms for all subjects entered in the study Copies of all case report forms for all subjects □ Copies of any corrections made, queries, etc. Source documents for all subjects (office charts, test results, etc.) Study document file

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All study initiation records List of involved study personnel and dates of involvement All IRB communications Sponsor communications Study notes, etc. Grant information should not be present

Drug dispensing records for all subjects Overall drug accountability forms Other materials, as requested or as appropriate

Audit Preparation Checklist – 15 February 2005

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