Audit/Inspection Preparedness for Clinical Research/Site Coordinators

Why Should You Attend:

The Clinical Research Coordinator (CRC) plays a key role in the site’s success at audits/inspections, and must therefore know how to ensure the site is ready for an audit or inspection at all times.

In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of the clinical research at the site complies with them. The site coordinator must know how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. Following the audit or inspection, the site coordinator should be able to appropriately act upon the audit or inspection findings.

This 60-minute presentation will detail the responsibilities of the Investigator and the clinical research coordinator during and after Site Audits/Inspections. We will discuss how you can prepare your clinical site for audits/inspections and ensure readiness at all times. This webinar will provide valuable assistance to the Clinical Research Personnel in the Pharmaceutical, Biotech and Medical Device industries.

Learning Objectives:

• Understand what Audits/Inspections are all about.
• Learn how to ensure Audit/Inspection readiness are maintained at all times.
• Learn how to prepare for a planned Audit/Inspection.
• Become familiar with the DOs and DON'Ts prior and during an Audit or Inspection.
• Understand what actions are required following an Audit/Inspection.

Areas Covered in the Seminar:

• Audits and Inspections: Definitions, Goals, Causes and Procedures.
• Clinical Site Audits/Inspections findings and FDA warning letters.
• Responsibilities of the Investigator and the clinical research coordinator
• Keeping site's continuous Audit/Inspection preparedness.
• Preparation for a planned Audit/Inspection.
• Appropriate conduct during the Audit/Inspection.
• Completion and follow up after the Audit/inspection.
• DOs and DON'Ts prior to, during and after an Audit/Inspection.

Who will Benefit:

This webinar will provide valuable assistance to the following Clinical Research Personnel in the Pharma, Biotech and Medical Device industries:

• Clinical Research/Site Coordinators
• Clinical Research Investigators
• Clinical Research Associates / Monitors
• Clinical Research / Project Assistants
• Clinical Research Trainers
• Clinical Team managers
• Regulatory Compliance Associates and Managers

Instructor Profile:

Ornat Katzir , MSc., MHA

Over 15 years of experience in clinical research:

• CRA and GCP manager in a US international pharmaceutical company
• Sr.CRA, Principal CRA, Team manager and The Israeli Associate Clinical Operations manager of a large US CRO
• Quality Management Systems Associate of a large US international CRO
• Independent Clinical Research Consultant, GCP auditor and trainer

Hands on experience in various aspects of clinical research:

• Monitoring and management of all stages of clinical research
• Development and review and assessment of clinical research documents and tools (Protocols, Informed Consent Forms, Case Report Forms, Questionnaires etc.) for compliance with applicable standards and regulations
• Development, review and assessment of internal systems/processes, standard operating procedures and working practice documents for compliance with applicable standards and regulations
• Systems and process audits and development of methodology and tools for these audits/reviews
• Development and quality check of documents summarizing the requirements for clinical trials in specific regions/countries
• Conduct of sponsors, CROs, sites and vendors GCP Audits
• Training clinical research personnel (sponsor/CRO and research sites teams)

Topic Background:

The investigator is responsible to conduct the clinical research in accordance with the signed agreement, relevant, current protocol(s) and the applicable regulatory requirements and international guidelines. The investigator may delegate many tasks to the clinical research/site coordinator (CRC). The CRC oversees the daily clinical activities and may represent the investigator when interfacing with the sponsor, the subjects, the site staff and other involved parties. The role of the site coordinator is therefore crucial – a dedicated, knowledgeable CRC is the key for the appropriate conduct of the clinical research activities at the clinical site throughout the clinical trial.

The most acceptable way for the sponsors, CROs or regulatory authorities to confirm that the clinical investigators/sites conduct the study in compliance with the applicable regulatory and sponsor requirements, guidelines and SOPs, is to conduct an audit or an inspection of the clinical site. Audits and inspections follow similar processes with similar outcomes although they are handled differently. QA audits are scheduled way in advance whereas regulatory authority inspections might occur without or with a very short prior notice. The site coordinator will be required to prepare the site for the audit/inspection as well as attend any audit or inspection held at the site, to facilitate the auditor/inspector’s work and answer their questions.
Following the audit/inspection the findings will be communicated to the site and the site coordinator might be delegated the responsibility to answer the auditor or the regulatory authority, and conduct the corrective actions required.

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