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PNGIMR / Case Western Reserve University

Audit Preparation Checklist

PRINCIPAL INVESTIGATOR’S NAME INSTITUTION NAME STUDY NAME / PROTOCOL NO.

Susceptibility to Plasmodium vivax Infection


Case Western Reserve
Peter A. Zimmerman, PhD and Malaria during Early Childhood / DMID
University
Protocol No. 02-004

1. Ensure that arrangements have been made for the audit


□ Conference room is arranged/reserved
□ 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:
□ 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
□ 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 Page ____ of ____