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Auditor

Clinical Research

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Geethika Gummadi
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246 views11 pages

Auditor

Clinical Research

Uploaded by

Geethika Gummadi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF or read online on Scribd
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AUDIT * Audit is a systematic and independent examination of trial- related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analysed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practices (GCP), and the applicable regulatory requirements DIFFERENT TYPES OF AUDITS Investivational site audit sponsor central file Clinical department audit process audit Clinical laboratory Data management audit audit Safety department audit TYPES OF INVESTIGATIVE AUDIT * to evaluate the compliance of the study team * usually performed when study is in process or after completion * to verify the suspected non compliance by the study team based on the complaints by CRA, sponsor or IRB * commonly performed Clinical Auditor The auditors are independent individuals appointed by sponsors/regulatory authorities to conduct a systematic and in depth examination of trial conduct, and compliance with Protocol, SOPs, GCP. GLP, GPP and the applicable 1 gulatory requirements * medicine / life science /pharmacy background * clinical research methodology and management * GCP and regulatory guidelines * SOPs and protocol * Therapeutic areas * Excellent communication and interpersonal skills Positive attitude Diplomacy Confident and assertive nature Time management Training Before The Audit * Notification to the site: about date and detailed agenda about time * Reviews: . case report forms local regulation and guideline Project specific guideline © ~=Relevant SOPs Also contacts the monitor to ask few questions about centre Data query and diary cards During The Audit OPENING THE MEETI Perera Pen Rate) Pico temic team(investigators team) 2.Briefly explain a ‘ope, purpose , Perea cel Pre bts DOCUMENT REVIEW AND ECTING INFORMATION AUDITORS CHECK LIST neck list to answer the questions raised during the AUDIT OBSERVATIONS Peon) Poo teen eee Cones) SIS cegiay tate cee PO Ooe i a standard requirements PUG Rue ee PTET) nr aed Sly cei) ee CCCs ea After The Audit

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