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Clinical Trials: Preparing for an Audit or Inspection

Certification Training
Rated 4.50/5
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Program/Course ID: GCP006
Enrollment Period: 3 months.
Average Learning Time: ~150 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2.5 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $225.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: Clinical Trials: Preparing for an Audit or Inspection
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

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.

This module describes what investigational medicinal product sponsors, contract research organizations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators.

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.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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 inspection 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, organizational 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 offices is followed by detailed description of what the inspectors examine as regards organization 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.

Multiple-choice mastery assessment.


Who will benefit from this module?
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 departments of pharmaceutical companies and CROs, to independent clinical research associates, and to healthcare professionals conducting clinical studies.

Learning objectives
  • Discuss principles of GCP inspections and audits
  • Specify activities to be carried out in preparation for an inspection
  • Describe what happens when a European regulator inspects the site of a sponsor or contract research organisation
  • Describe what happens when a European regulator inspects the site of a clinical investigator
  • Describe what happens when the US Food and Drug Administration inspects the site of a sponsor or contract research organisation
  • Describe what happens when the US Food and Drug Administration inspects the site of a clinical investigator
  • Specify post-inspection actions by the regulator and the inspected party

Clinical Trials: Preparing for an Audit or Inspection is Included in the Following Professional Certification Program(s):

Professional Certification Program:

Clinical Trials Monitoring Professional Certification Program for CRAs
Course ID: GCP00A
Price: $695.00 (USD) | Learn more

Professional Certification Program:

Clinical Trials Management (US & EU) Professional Certification Program
Course ID: GCP00A1
Price: $1295.00 (USD) | Learn more

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Online Training: The Benefits of Remote Learning & eLearning

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