Name: CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Price: 98 GBP
Availability: InStock

<p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;"><span style="color: rgb(84, 89, 95); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(84, 89, 95);">This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).</span></p>

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

Zenosis

Good Manufacturing Practice (GMP)

Biotechnology

Pharmaceutical

Pharmacology

Drug Safety

Medical

GXP01- Good Practices (GxP) in Drug Development and Manufacturing

General Admission

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);"><span style="color: rgb(51, 51, 51); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(51, 51, 51);">This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).</span></p>

Healthcare

GXP01: Good Practices (GxP) in Drug Development and Manufacturing

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation&#39;s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH&rsquo;s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.</p>

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

CT03a - ICH, harmonisation, and principles of Good Clinical Practice

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation&rsquo;s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This module introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonisation and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">The module is fully up to date with Revision 2 of ICH GCP.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This training meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.</p>

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
This module introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonisation and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
The module is fully up to date with Revision 2 of ICH GCP.
This training meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Healthcare IT

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

CT03: ICH Good Clinical Practice

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);">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.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">This module describes what investigational medicinal product sponsors, contract research organisations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators.</p><p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" fr-original-style=" color: rgb(51, 51, 51);">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.</p>

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 organisations 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.

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.

CT09: Good Clinical Practice Inspections and Audits

<div><h2> About Course</h2><div> <strong>Understand the Ethical and Regulatory Framework for Conducting Clinical Trials</strong>  <div></div><div><div><div></div></div></div><div></div><div><div><div><p><strong>Course Description</strong></p><p>This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into <span>the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring</span> you grasp the essential standards for conducting clinical research.</p><p><strong>Course Objectives</strong></p><p>By the end of this course, you will be able to:</p><ul><li>Articulate the definition, purpose, and historical context of GCP.</li><li>Explain the importance of GCP in protecting human subjects and ensuring data integrity.</li><li>Identify key international organizations involved in establishing GCP standards.</li><li>Apply ethical principles and informed consent procedures in clinical research.</li><li>Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.</li><li>Design and conduct clinical trials according to ICH E8 and E9 guidelines.</li><li>Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.</li><li>Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.</li><li>Navigate regulatory compliance and inspections related to clinical trials.</li></ul><p><strong>Target Audience</strong></p><p>This course is designed for individuals who:</p><ul><li>Are interested in pursuing a career in clinical research or clinical trial management.</li><li>Work in the pharmaceutical, biotechnology, or medical device industry.</li><li>Seek to gain a comprehensive understanding of GCP principles and practices.</li></ul><p><strong>Prerequisites</strong></p><p>No prior experience in clinical research is required. However, a basic understanding of research methodology and medical terminology is recommended.</p><p><strong>Please Note:</strong></p><p>This course is strictly theoretical and <strong>does not qualify participants for clinical practice</strong> in the industry. Additional training and certifications may be required for hands-on experience.</p></div></div></div></div></div> <div><h3> What Will You Learn?</h3><ul><li> <span></span> <span>Articulate the definition, purpose, and historical context of GCP.</span></li><li> <span></span> <span>Explain the importance of GCP in protecting human subjects and ensuring data integrity.</span></li><li> <span></span> <span>Identify key international organizations involved in establishing GCP standards.</span></li><li> <span></span> <span>Apply ethical principles and informed consent procedures in clinical research.</span></li><li> <span></span> <span>Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.</span></li><li> <span></span> <span>Design and conduct clinical trials according to ICH E8 and E9 guidelines.</span></li><li> <span></span> <span>Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.</span></li><li> <span></span> <span>Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.</span></li><li> <span></span> <span>Navigate regulatory compliance and inspections related to clinical trials.</span></li></ul></div><div><h3> Course Content</h3><div><div><h4> Introduction to Good Clinical Practice (GCP) and ICH Guidelines</h4><div><div><ul><li><div> <span></span><h5> Introduction to Good Clinical Practice (GCP) and ICH Guidelines</h5></div><div> </div></li></ul></div></div></div><div><h4> Ethical Principles, Informed Consent, and ICH E6(R2)</h4><div><div><ul><li><div> <span></span><h5> Ethical Principles, Informed Consent, and ICH E6(R2)</h5></div><div> </div></li></ul></div></div></div><div><h4> Designing and Conducting Clinical Trials with ICH E8 and E9</h4><div><div><ul><li><div> <span></span><h5> Designing and Conducting Clinical Trials with ICH E8 and E9</h5></div><div> </div></li></ul></div></div></div><div><h4> Data Management and Reporting with ICH E6(R2)</h4><div><div><ul><li><div> <span></span><h5> Data Management and Reporting with ICH E6(R2)</h5></div><div> </div></li></ul></div></div></div><div><h4> Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3)</h4><div><div><ul><li><div> <span></span><h5> Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3)</h5></div><div> </div></li></ul></div></div></div><div><h4> Regulatory Compliance, Inspections, and ICH E6(R3)</h4><div><div><ul><li><div> <span></span><h5> Regulatory Compliance, Inspections, and ICH E6(R3)</h5></div><div> </div></li></ul></div></div></div></div></div>A course by  Xpert Learning  RequirementsA basic understanding of research methodology and medical terminology is recommended. Audience  Individuals who are interested in pursuing a career in clinical research or clinical trial management.  Individuals who work in the pharmaceutical, biotechnology, or medical device industry.  Individuals who seek to gain a comprehensive understanding of GCP principles and practices.<h3> Audience</h3><ul><li> <span></span> <span>Individuals who are interested in pursuing a career in clinical research or clinical trial management.</span></li><li> <span></span> <span>Individuals who work in the pharmaceutical, biotechnology, or medical device industry.</span></li><li> <span></span> <span>Individuals who seek to gain a comprehensive understanding of GCP principles and practices.</span></li></ul>

 About Course
Understand the Ethical and Regulatory Framework for Conducting Clinical Trials
Course Description
This comprehensive Good Clinical Practices (GCP) course provides a thorough understanding of the ethical and regulatory principles governing clinical trials. It delves into the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, ensuring you grasp the essential standards for conducting clinical research.
Course Objectives
By the end of this course, you will be able to:
Articulate the definition, purpose, and historical context of GCP.
Explain the importance of GCP in protecting human subjects and ensuring data integrity.
Identify key international organizations involved in establishing GCP standards.
Apply ethical principles and informed consent procedures in clinical research.
Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
Design and conduct clinical trials according to ICH E8 and E9 guidelines.
Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
Navigate regulatory compliance and inspections related to clinical trials.
Target Audience
This course is designed for individuals who:
Are interested in pursuing a career in clinical research or clinical trial management.
Work in the pharmaceutical, biotechnology, or medical device industry.
Seek to gain a comprehensive understanding of GCP principles and practices.
Prerequisites
No prior experience in clinical research is required. However, a basic understanding of research methodology and medical terminology is recommended.
Please Note:
This course is strictly theoretical and does not qualify participants for clinical practice in the industry. Additional training and certifications may be required for hands-on experience.
 What Will You Learn?
Articulate the definition, purpose, and historical context of GCP.
Explain the importance of GCP in protecting human subjects and ensuring data integrity.
Identify key international organizations involved in establishing GCP standards.
Apply ethical principles and informed consent procedures in clinical research.
Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
Design and conduct clinical trials according to ICH E8 and E9 guidelines.
Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.
Navigate regulatory compliance and inspections related to clinical trials.
 Course Content
Introduction to Good Clinical Practice (GCP) and ICH Guidelines
Introduction to Good Clinical Practice (GCP) and ICH Guidelines
Ethical Principles, Informed Consent, and ICH E6(R2)
Ethical Principles, Informed Consent, and ICH E6(R2)
Designing and Conducting Clinical Trials with ICH E8 and E9
Designing and Conducting Clinical Trials with ICH E8 and E9
Data Management and Reporting with ICH E6(R2)
Data Management and Reporting with ICH E6(R2)
Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3)
Safety and Monitoring in Clinical Trials with ICH E6(R2) and E6(R3)
Regulatory Compliance, Inspections, and ICH E6(R3)
Regulatory Compliance, Inspections, and ICH E6(R3)
A course by Xpert Learning RequirementsA basic understanding of research methodology and medical terminology is recommended. Audience Individuals who are interested in pursuing a career in clinical research or clinical trial management. Individuals who work in the pharmaceutical, biotechnology, or medical device industry. Individuals who seek to gain a comprehensive understanding of GCP principles and practices.
 Audience
Individuals who are interested in pursuing a career in clinical research or clinical trial management.
Individuals who work in the pharmaceutical, biotechnology, or medical device industry.
Individuals who seek to gain a comprehensive understanding of GCP principles and practices.

Xpert Learning

Good Laboratory Practice (GLP)

Clinical Governance

Clinical Research

RCGP

Good Clinical Practice (GCP)

Good Clinical Practices: A Practical Guide to GCP Compliance

Hayes

Course Information
Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines.
How is this course run?
Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys.
What will I learn?
A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments
Solid grounding in quality assurance activities aligned with regulatory standards
Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues
Clarity on the roles and responsibilities inherent to clinical trials auditing
Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents
A nuanced understanding of regulatory inspectors' activities
Expanded professional networks to propel your auditing career forward.
Benefits include:
A clear understanding of the role of the auditor under Good Clinical Practice improved audits
Improved Good Clinical Practice compliance for your clinical trials.
This course is structured to encourage delegates to:
Discuss and develop ideas
Solve specific problems
Examine particular aspects of Good Clinical Practice.





Tutors
Tutors will be comprised of (click the photos for biographies):

Rosemarie Corrigan
EVP Global Quality, Worldwide Clinical Trials

Cathy Dove
Director and Owner, Dove Quality Solutions

Julie Kelly
Associate Director, Clinical Quality Assurance, Corcept Therapeutics

Susana Tavares
Director of Research Quality Assurance, -



Programme
Please note timings may be subject to alteration.


Day 1
12:30
Registration
13:00
Welcome and Objectives for the first day of the course
13:30
Laying the Foundations
Introduction to the clinical development process, the concepts of quality assurance, quality control and audit.
14:30
Break
15:00
Patient Protection
Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise.
16:05
Workshop 1 - Case Study on Informed Consent
16:45
End of Day Questions and Answers
17:00
Close of Day


Day 2
08:50
Questions and Answers from Day 1
09:00
Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
09:40
Workshop 1 - Planning the Effective Audit
10:30
Break
10:45
Source Data Verification
The need for and purpose of verifying data.
11:25
Workshop 2 - Source Data Verification
12:30
Lunch
13:30
IMP Management
The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction.
14:15
Critical Document Audits
The conduct of other study specific audits including protocols, databases and reports.
15:00
Break
15:15
Non-compliance
Determining the acceptability of data.
16:00
Fraud - Fact or Fiction?
How to identify fraud and its consequences
16:45
End of Day Questions and Answers
17:00
Close of Day


Day 3
08:50
Questions and Answers from Days 1 and 2
09:00
Auditing Third Parties
A review of audits of contract research organisations.
10:00
System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.
10:45
Break
11:00
Workshop 3 - Process Mapping
11:45
Effective Audits
Where theory meets reality.
12:30
Lunch
13:20
Audit Reports - Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit.
14:20
Workshop 4 - Audit Reports
Audit reports, corrective and preventive action.
15:00
Break
15:10
Regulatory Inspection
Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection.
15:55
Final Questions and Answers
16:10
Close of Course



Extra Information


Face-to-face course
Course Material
Course material will be available in PDF format for delegates attending this course. The advantages of this include:
Ability for delegates to keep material on a mobile device
Ability to review material at any time pre and post course
Environmental benefits – less paper being used per course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.


Remote course
Course Material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
Ability for delegates to keep material on a mobile device
Ability to review material at any time pre and post course
Environmental benefits – less paper being used per course Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
CPD Points
17 Points
Development Level
Develop

Research Quality Association

Good Clinical Practice Auditing - Principles and Practice

RQA Member

Non Member

<p fr-original-style="" style="color: var(--text); font-size: var(--font-size); box-sizing: border-box;">GCP Good Clinical Practice</p>

NBScience

GCP Good Clinical Practice

Course Information
Join us for a two-day immersive course crafted to equip participants with an in-depth understanding of remote audit methodologies. Delve into the nuances between remote and face-to-face audits, dissecting their respective strengths and limitations. Through practical scenarios tailored for remote audit conduct, this course stands as an essential counterpart to our on-site audits course The Auditing Course.
Who Should Attend:
Applicable across various domains of regulated research and development, this course proves invaluable in contexts requiring a quality system for audit. Participants with firsthand audit experience stand to gain the most benefit from this programme.
Expanding on Previous Learning:
This course extends its relevance to all forms of audits and further amplifies concepts explored in RQA's suite of research quality assurance courses, including: 'Research Quality Assurance for Good Laboratory Practice,' 'Good Clinical Practice Auditing – Principles and Practice,' and 'Good Manufacturing Practice for Investigational Medicinal Products.'
Benefits include improved:
Understand the processes of planning, conducting, reporting and follow-up of audits
Recognising the importance of personal approach in developing positive audit outcomes
Ability to analyse evidence and present logical audit findings
Appreciate the importance of audit in continuing improvement.
This course is structured to encourage delegates to:
Discuss and develop ideas
Solve problems
Exchange information.





Tutors
Tutors will be comprised of (click the photos for biographies):

Andrew Waddell
Founder Director, Tower Mains Ltd
Rosemary Ichaba
Senior QA Associate, Tower Mains Ltd

Cate Ovington
Director, The Knowlogy Group Ltd

Jean McWilliam
Associate Director, Alexion



Programme
Please note timings may be subject to alteration.


Day 1
09:00
Course Registration
09:15
Welcome and Introductions
09:35
Introduction to Audits
Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements.
10:05
Introduction to Remote Audits
Presentation to introduce the major differences between face-to-face audits and remote audits. The major elements of audits will be examined to determine where there may be differences.
10:30
Break
10:45
Workshop 1 - Remote Audits
This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits.
11:15
Workshop 1 - Feedback
11:35
Audit Preparation
The essential steps in preparation for audits will be discussed with emphasis on remote audits.
12:05
Workshop 2 - Remote Audit Preparation
Factors relating to the preparation for remote audits will be considered in discussion groups.
12:35
Workshop 2 - Feedback
12:50
Lunch
13:30
Audit Logistics
Preparation for the audit includes many arrangements other than the audit content.
14:00
Workshop 3 - Audit Logistics
Delegates will discuss some of the issues that may occur during the set up and conduct of remote audits and how to resolve them.
14:30
Workshop 3 - Feedback
14:45
Break
15:00
The Opening Meeting
Presentation regarding the importance and content of the opening meeting.
15:20
Workshop 4 - Opening Meeting
Delegates will consider the practicalities of arranging and conducting an opening meeting.
15:45
Workshop 4 - Feedback
16:10
Audit Conduct Tools
Practical advice on preparation of some of the tools that will be valuable in the conduct of audits.
16:40
Questions and Answers
An overview of the first day and a chance to ask questions
17:00
Close of Day


Day 2
09:00
Reflections on Day 1
Recap on the topics covered and a chance for delegates to raise points.
09:15
Gathering Evidence
Presentation on challenges of gathering evidence and conducting interviews during remote audits.
09:45
Workshop 5 - Remote Interviews
Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach.
10:15
Break
10:30
Creating Audit Findings
Ideas regarding how to create good audit findings will be discussed during this short presentation.
10:50
Workshop 6 - Creating Audit Findings
Delegates will be provided with examples of evidence from an audit. They will discuss these and create their audit findings for presentation at the closing meeting.
11:35
The Closing Meeting
The content and conduct of the closing meeting will be discussed.
11:55
Workshop 7(a) - Preparing for the Closing Meeting
The findings from workshop 6 will be reviewed and a Lead Auditor selected to provide feedback in workshop 7(b)
12:15
Workshop 7(b) - The Closing Meeting
The Lead Auditor from each group will hold a meeting to present the results (role play).
12:45
Lunch
13:30
The Audit Report
This presentation will cover not only the essential contents of the audit report but also how to write the report in a manner that will generate the most positive reaction.
14:00
Workshop 8 - The Audit Report
Delegates will be provided with an audit report from an audit conducted remotely and will conduct a peer review of the report in their breakout groups.
15:00
Workshop 8 - Feedback
15:20
Break
15:35
Audit Closure
Presentation on how to conclude the audit with reference to post-audit activities.
15:55
Open Forum
16:30
Close of Course





Extra Information


Course material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
Ability for delegates to keep material on a mobile device
Ability to review material at any time pre and post course
Environmental benefits – less paper being used per course Access to an online course group to enhance networking
You will need a stable internet connection, a microphone and a webcam.
 

The Remote Auditing Course

<p style="color: rgb(51, 51, 51); font-size: var(--font-size); box-sizing: border-box;" id="isPasted" fr-original-style=" color: rgb(51, 51, 51);"><span style="color: rgb(51, 51, 51); box-sizing: border-box;" id="isPasted" fr-original-style="color: rgb(51, 51, 51);">The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.</span></p>

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

Educators providing Good Clinical Practice (GCP) courses delivered Online