Audits

Click Here to Begin Lesson

Upon completion of this activity, learners will be able to:
Explain the purpose and scope of an audit.
Define the two conditions for audits.
List the common compliance areas reviewed during an audit.

Reference
Modules:  Introduction and Preparing for a Site Audit
https://www.advarra.com/resource-library/preparing-for-and-responding-to-an-fda-inspection/
https://nccih.nih.gov/sites/nccam.nih.gov/files/cr-toolbox/regulatory_binder_checklist_ver3_07-17-2015.docx
https://mtnstopshiv.org/sites/default/files/attachments/Site_FDA_Inspection_Preparation_Checklist_v1[1].0_22Nov10.doc

Module:  Participating in a Site Audit
https://oprs.usc.edu/files/2017/05/FDA-SHEDDING-LIGHT-PRESENT-for-USC-Oct-2016.pptx
https://nbscience.files.wordpress.com/2014/12/audit2.ppt
https://www.fdanews.com/ext/resources/files/The_Food_And_Drug_Letter/2013/Inspection-Readiness-ExecSeries.pdf
http://www.med.upenn.edu/ocrobjects/library/HowtoSurviveFDA_Audit.pdf
https://www.advarra.com/resource-library/preparing-for-and-responding-to-an-fda-inspection/

Module:  Addressing the Findings
https://research.unc.edu/files/2018/02/2.7.18-ctqa-common-findings-presentation.pdf
http://compliance.emory.edu/documents/AuditFindingsinClinicalTrials.pdf
https://www.fda.gov/media/87613/download

Raju S, Vijaya Lakshmi N, Sathish M. Audit of an investigator site – a crucial task in clinical research to ensure a reliable clinical trial: review of planning, methodology and techniques. International Journal of Research and Development in Pharmacy and Life Sciences 2016;5(4):13-29.

Developer: Dana Shaw-Bailey, M.Ed.
Contributors: Darri Scalzo; Candi Langmaid; Kurtis Kulbeth, BS; Carol Sikes, RN, MScN; Phyllis Nader, BSE
Narrator:  Kristina Foster, MS, RN