Clinical Research Professionals
A professionally developed, interactive and engaging online training course.
Delivering unique, exciting and interactive e-learning technology courses.
ABOUT THE COURSE
Since 1996, when the ICH GCP E6 guidance was established, the role of the monitor has evolved, becoming increasingly accountable and complex. More sponsors have implemented risk-based monitoring approaches. E6 R2 discusses this risk-based approach in more detail and how this impacts the reporting and monitoring plan.
This interactive an engaging online course has been designed to provide an in depth understanding of the roles and responsibilities of a Clinical Research Professional. It is mainly aimed at the role of a CRA/monitor but it is also suitable for other roles that support a monitor such as a Clinical Trials Assistant, Project Managers or site staff wanting to gain a greater understanding of Clinical research. A. On completion of this training, participants will be able to apply their knowledge and skills to become an effective Clinical Research Professional. A certificate will be available once the assessment at the end of this course is completed with a pass rate of 80% or more.
Finally an online learning platform thats fun, engaging and can be taken on any device, anywhere, anytime.
HOW LONG
WlLL THE COURSE TAKE?
This course takes approx. 2-3 hrs to complete. This time will vary depending on the users previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Clinical Research Professionals
£349.00 (inc VAT)
COURSE CONTENTS
Chapter 1 - What is Clinical Research?
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Introduction to clinical research
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Sponsor responsibilities
Chapter 2 - Ethics Committees / IRB
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Ethics Committees/Institutional Review Boards
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IEC and Competent Authorities (CA)
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Review of IEC/CA responsibilities
Chapter 3 - Monitoring
- Introduction to monitoring
- Why Monitor a Trial?
- Types of monitoring
- Risk based monitoring
Chapter 4 - Informed Consent
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Informed Consent-introduction
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The 5 Steps of the Informed Consent Process
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Informed Consent in detail
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What should an ICF contain?
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How to monitor the informed Consent process
Chapter 5 - Patient Safety
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Patient safety- introduction
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The reasons for and elements of safety reporting
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What to do when AE, SAE or SUSAR occur
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Monitoring and reporting-patient safety
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Reporting of ADR and SUSAR
Chapter 6 - Essential Documents
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Essential Documents
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Documentation before, during and after a clinical trial
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General rules for archiving Essential Documents
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Monitor Responsibilities- Essential Documents
Chapter 7 - Investigation Product
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Investigational Products
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How to monitor IP
Chapter 8 - Source Document Verification
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What is source documentation?
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Verifying Subject data, the monitoring report and plan.
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Types of data- knowledge check
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ALCOA+
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Late entries and corrections
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Electronic Medical Records (EMR)
Chapter 9 - Questionable Data
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Definitions
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What should a monitor look for?
Chapter 10 - Queries
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What are queries?
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Dealing with queries
Chapter 11 - Audit and Inspection
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What are audits and inspections?
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Monitor conduct-Audits and Inspections
Chapter 12 - Knowledge Check
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Phone
0161 633 4594
Address
82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT