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IRAS Training - ONLINE
(Spaces available: )
This online module is designed to support the use of the Integrated Research Application System (IRAS), including how to access the help and guidance available.
This module will take approximately one hour.
This module is for anyone who is doing health and community care research
No need to register - go straight to:
www.myresearchproject.org.uk/Elearning/
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Research and human tissue legislation - ONLINE
(Spaces available: 499)
This online learning module provides an overview of Human Tissue Act 2004 and Human Tissue (Scotland) Act 2006.
When the Acts apply
What constitutes best practice
Top tips to support compliance
Where to find help
No need to register - go straight to:
www.rsclearn.mrc.ac.uk
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Options
Request a place on this on-line learning
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Investigational Medicinal Product Management at the Investigator Site: Regulatory Inspectors' Views
(Spaces available: 47)
Wednesday 18 August 2010 15:00
to 16:30
ACRP (UK Office) is working closely with the UK Regulatory Authority, Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate group to deliver 4 educational webinars on areas of concern particularly at Investigator Sites. The first webinar will be on the topic of Investigational Medicinal Product (IMP) management at the investigator site and will be provided by a Good Manufacturing Practice (GMP) Inspector and Good Clinical Practice (GCP) Inspector.
The inspectors will discuss the inspection findings from the results of their UK Good Clinical Practice Inspections. The Good Clinical Practice (GCP) Inspectorate is part of the Inspections & Standards Division of the MHRA. It assesses the compliance of organisations conducting clinical trials using investigational medicinal products with UK and EU legislation and take enforcement action where necessary. The webinar will cover the key challenges of IMP management at the investigator site, including primary care and university settings for both commercial and non-commercial sponsors. Critical findings from GCP Inspections and the recommended actions will be discussed in relation to IMP management and compliance with the regulations. The role of the qualified person (QP) will also be explained as their responsibilities can cause some confusion. The aim of the webinar is to learn from the GCP inspection findings, improve investigator site performance, IMP management and safety and also improve future inspection findings and importantly adherence to the regulations. Auditors, CRAs/Monitors will learn more about monitoring compliance in the area of IMP management and be able to advise the investigator site on recommended actions
Cost
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£15.00
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NHS/University rate
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Options
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Good Clinical Practice & EU Directive Half Day UPDATE
(Spaces available: 22)
Thursday 19 August 2010 09:30
to 13:00
For personnel with previous GCP training. Mixture of lectures and workshops.
1) Amendments to the regulations principles of GCP
2) Preparing for an MHRA inspection
3) Standard Operating Procedures - interactive session
4) Trail Master Files
5) Pharmacovigilance - series of case studies
Cost
There is a cancellation date of Thursday 05 August 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Consent for Tissue - Collecting, storing and using Human Tissue
(Spaces available: 25)
Monday 06 September 2010 14:00
to 16:00
This course will provide information on the ethical and legal principles of consent to collect, use and store human tissue. Group discussions will focus the consent requirements using ‘real-life’ scenarios involving the collection and use of human tissue from patients, healthy volunteers and colleagues.
Cost
There is a cancellation date of Monday 23 August 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Literature Searching with Medline
(Spaces available: 5)
Wednesday 08 September 2010 10:00
to 16:00
A combination of demonstrations & hands-on practical sessions using the biomedical database Medline, starting at an introductory level and working up to advanced searches during the course of the day.
Cost
There is a cancellation date of Wednesday 25 August 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Introduction to Sample Size & Power Calculation for Clinical Research
(Spaces available: 29)
Wednesday 06 October 2010 13:00
to 15:00
An introductory seminar describing the necessary background knowledge & information required to carry out a sample size calculation
Cost
There is a cancellation date of Wednesday 22 September 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Good Clinical Practice & EU Directive
(Spaces available: 18)
Tuesday 12 October 2010 10:00
to 16:30
Through a mixture of lectures and workshops this course:
1) Provides a history of clinical trials and the development of GCP
2) Deciding what is a clinical trial as per EU Directive discussion of informed consent - the ethical and statutory imperatives with particular reference to vulnerable groups
3) Responsibilities of research personnel and the process for obtaining approvals to conduct clinical trials
4) Overview of the 14 principles of GCP
5) Pharmacovigilance - definitions and a series of case studies are discussed
6) 'Monitoring' exercise - group exercise to highlight examples of breaches of GCP and documentation discrepancies that can occur
Cost
There is a cancellation date of Tuesday 28 September 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Good Clinical Practice & EU Directive Half Day UPDATE
(Spaces available: 23)
Wednesday 13 October 2010 09:30
to 13:00
For personnel with previous GCP training. Mixture of lectures and workshops.
1) Amendments to the regulations principles of GCP
2) Preparing for an MHRA inspection
3) Standard Operating Procedures - interactive session
4) Trail Master Files
5) Pharmacovigilance - series of case studies
Cost
There is a cancellation date of Wednesday 29 September 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
Request a place on this course
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How to Practice Evidence-Based Healthcare
(Spaces available: 20)
Thursday 14 October 2010 09:15
to 17:00
This 2 day introductory course is aimed at health care professionals and researchers who wish to gain knowledge of critical appraisal and experience in the practice of evidence-based health care. With a focus on quantitative research* and covering basic statistics, the course includes plenary sessions & small group work on:
•Appraisal of Clinical Trials
•Risk & Prognosis
•Systematic Reviews
•Literature Searching
*The course now also includes an optional session on critical appraisal of qualitative research.
Sessions
Thursday 14 October 2010 09:15
to 17:00
EBP in Practice,
Literature Searching,
Appraisal of Clinical Trials,
Small Group Work
Friday 15 October 2010 09:00
to 17:00
Risk & Prognosis,
Systematic Reviews,
Small Group Work
Cost
There is a cancellation date of Thursday 30 September 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
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Statistics for Clinical Researchers
(Spaces available: 10)
Wednesday 27 October 2010 09:15
to 16:00
A detailed & practical statistics course, run for 1 day a week over 5 weeks, covering basic statistical analyses and how to critically appraise analyses in the literature.
Sessions
Wednesday 27 October 2010 09:15
to 16:00
Presenting Experimental Results
Wednesday 03 November 2010 09:15
to 16:00
Understanding Confidence Intervals
Wednesday 10 November 2010 09:15
to 16:00
Understanding Hypothesis Tests and p-values
Wednesday 17 November 2010 09:15
to 16:00
Confidence Intervals and Hypothesis Testing
Qualitative (categorical) data
Wednesday 24 November 2010 09:15
to 16:00
Non-parametric Methods, Choosing the Statistical Method,
Power Calculations, Analysis of Variance
Cost
There is a cancellation date of Wednesday 13 October 2010. You will be charged if you cancel after this date.
Documents
Flyer
Registration Form
Registration Form
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Options
Request a place on this course
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