Conducting CI Site Audit samplepresentation

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Presentation Description

This course explains how to select clinical investigator sites for an audit. Additionally, it teaches attendees how to write an audit pan, prepare for an audit, conduct an audit and how to write an audit report.

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Presentation Transcript

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Sarah Wilson, BS., MS., CCRP President, WQATS, LLC Quality Assurance Expert

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Attendees will learn how to: Select clinical investigator (CI) sites for an audit. Choose Auditors. Prepare for a CI site audit (i.e. audit letter, audit plan, etc.). Audit the CI site. Write an audit report. Conduct audit follow-up.

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Selecting Clinical Investigator Sites

Conducting Clinical Investigator Site Audits – Things to Consider: 

Conducting Clinical Investigator Site Audits – Things to Consider Number of clinical investigators conducting the clinical trial. High enrollers. Large number of Adverse Events/ SAEs/Endpoints. High number of subject withdrawals.

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Choosing Your Auditor

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Tips for a successful audit Respect the auditee and demand respect in return. Respect boundaries. …………

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits Questions? Feel free to email questions to wqats@ureach.com

Conducting Clinical Investigator Site Audits: 

Conducting Clinical Investigator Site Audits For more training opportunities, please visit my website at www.wqats.com or contact me at wqats@ureach.com. Phone: 1-877-847-2186.

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