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.
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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, -
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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
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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