1. Module J Audits and Inspections Patricia E. Koziol 1Module J Final Version 1-May-2010

2. Guideline for Good Clinical Practice Audit Purpose The purpose of a Sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions should be to evaluate trial conduct and compliance with the Protocol, SOPs, GCP and the applicable regulatory requirements. Sec. 5.19.1 2Module J Final Version 1-May-2010

3. Selection/Qualification Auditors The Sponsor should appoint individuals who are independent of the clinical trial/data collection system(s) to conduct audits. The Sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. Sec. 5.19.2 3Module J Final Version 1-May-2010

4. Corrective and Preventative Action (CAPA) A corrective and preventative action plan is a strategy for correcting or eliminating a nonconformance that has occurred and preventing a nonconformance from occurring in the future. Module J Final Version 1-May-20104