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.
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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.