Good Clinical Practice Inspections and Audits

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements.

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements.

The module describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.

Module overview - An outline of the module’s scope and objectives, and notes on terminology.

Principles of GCP inspections and audits - Principles, applicable in any regulatory jurisdiction, of inspections and audits: their purpose, who carries them out, in what circumstances, and their possible consequences; routine versus targeted inspections; system versus study-specific inspections.

Preparing for an inspection - Actions you can take to prepare your site for a GCP inspection, whether you work for a sponsor or CRO or as a clinical investigator.

European regulators’ inspection of sponsor and CRO sites - Procedure for in spection of the site of a sponsor or CRO by the regulatory authority of a member state of the European Economic Area: pre-inspection provision of an inspection request and plan to the inspectee; quality system inspection; study-specific inspection.

European regulators’ inspection of investigator sites - Inspection of legal and administrative aspects, organisational aspects, informed consent provisions, subject data, and management of investigational medicinal products.

FDA inspection of sponsor and CRO sites - An outline of pre-inspection activity among the relevant FDA oces is followed by detailed description of what the inspectors examine as regards organisation and personnel, study registration, selection and monitoring of investigators, study monitoring, quality assurance, safety and adverse event reporting, data collection and handling, record retention, financial disclosure, computer systems, electronic records and signatures, and investigational product

FDA inspection of investigator sites - An outline of investigators’ legal obligations and the possible scope of an inspection is followed by detailed description of what the inspectors examine as regards authority and administration, clinical protocol, institutional review board, informed consent, source documents, CRFs, financial disclosure, investigational product control, records retention, reports to sponsor, and monitoring.

Action after an inspection or audit - This session describes post-inspection actions by regulators, and responses by inspected parties, with particular reference to European and US regulators: meetings at the close of inspections, inspection reports, classification of findings, responses and action plans, post-inspectional correspondence, and possible consequences of serious deficiencies.

This module will benefit all those involved in clinical research who already understand the basics of GCP. It will be of value to staff working in clinical, medical and QA depart- ments of pharmaceutical companies and CROs, to independent clinical research associates, and to healthcare professionals conducting clinical studies.

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1. What is included with the course?
Each course will include access to e-learning content, quizzes, and proof of completion. Additional resources may also be included and this will vary by course.

2. Can I pause the course and log in to it anytime?
Certainly. The course allows the learner to take a break and return to it within the defined access period (typically 365 days).

3. Are there any quizzes in the middle of the course?
Our e-learning courses are designed to promote interaction between learner and content and often include quizzes. Quizzes are designed to help understand where successful learning has been achieved, and where opportunities for additional review exist.

4. Can I get a refund if I cancel my enrollment?
Refunds cannot be provided once a course is activated. Please be sure to review course information prior to activation.

5. What happens if I don’t finish the course within the access period?
The standard access period is 365 days to allow sufficient time to complete your course.