This two and a half day course offers the ideal external training opportunity for those new to the auditing of clinical research and those moving into the area from monitoring or from auditing in other disciplines. It is directed principally towards the requirements of Good Clinical Practice and the methods for assuring that these requirements have been met. The first afternoon of the course provides an introduction to Good Clinical Practice. The remaining two days concentrate on the practicalities of clinical trial audit.
Managing Director, Strickland Quality Assurance Ltd (Course Principal)
Head of QA, Thrombogenics
Director and Owner, Dove Quality Solutions
Head of Research QA, BIAL-Portela & Companhia SA
"The course was really [excellently] prepared, presented and captured all relevant point of views of GCP practices."
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this 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.
Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.
Day 1 - GCP Introduction
12.00 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
14.20 Today’s Regulatory Framework
A brief review of the regulations and guidelines that describe Good Clinical Practice.
15.30 Patient Protection
Requirements for informed consent and ethics committees
Access to source documentation
Including a patient protection exercise
17.30 Questions and Answers
17.45 Close of day
8.50 Welcome and Course Objectives
9.00 Effective Site Audits
The procedures involved in selecting and setting up audits at investigator sites.
9.35 Introduction to Workshops
9.45 Workshop 1 – Planning the Effective Audit
10.50 IMP Management
The requirements surrounding the distribution of investigational medicinal products
Accountability from release to destruction
11.30 Workshop 2 –Drug Accountability
12.15 Workshop 2 – Feedback
13.25 Source Data Verification
The need for and purpose of verifying data.
13.55 Workshop 3 – Source Data Verification
15.10 Workshop 3 – Feedback
16.00 Critical Document Audits
The conduct of other study specific audits including protocols, databases and reports.
16.45 Non-compliance Determining the acceptability of data
17.30 Close of day
8.50 Questions and Answers
9.20 Auditing Third Parties
A review of audits of contract research organisations.
10.40 System Audits
The concept of auditing processes across many clinical trials, including a practical exercise in process mapping.
11.15 Workshop 4 – Process Mapping
11.55 Effective Audits
Where theory meets reality.
13.10 Audit Reports – Closing the Loop
An examination of the processes which follow the evidence gathering phase of the audit.
13.25 Workshop 5 – Audit Reports
Audit reports, corrective and preventive action.
14.40 The Role of the Regulatory Agencies
16.05 Fraud – Fact or Fiction?
A final opportunity to get answers to outstanding questions.
16.40 Close of course
A Monitor’s Guide to Investigator Site Audits Booklet
CAPA: Effective approaches to improvement
Good Clinical Practice Regulatory Authority Inspections Booklet
Investigators Guide to Investigator Site Audits Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments
C9082 The Auditing Course
(11th Sep 2018 - 12th Sep 2018)
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)
C9101 Implementing GCLP (3rd Oct 2018 - 4th Oct 2018)
C9102 Implementing GCLP (12th Mar 2019 - 13th Mar 2019)
C9212 Audit Programmes and Risk Assessment (9th Apr 2019)
C9411 Advanced Auditing Skills: Audit Planning and Performance (3rd Sep 2018 - 4th Sep 2018)
C9421 Advanced Auditing Skills: Audit Analysis and Reporting (5th Sep 2018 - 6th Sep 2018)