Start date
06-Jul-09
End date
06-Jul-09
Location
ICR, Bourne End
Contact Details
Event Details
Course overview
The aim of this course is to examine how clinical trial data are collected, reviewed at the site by the monitor and what happens to the data once it is scrutinised by the Sponsor’s data management function. This course will enable study site personal to get a Sponsor’s perspective on clinical study data and its management in the context of the clinical trial process. The ultimate aim is to ease the data handling process at site and minimise the number of data queries for the benefit of both the Study Site Team and the Sponsor.
Who should attend?
This one day course is aimed at Study Site Personnel such as Investigators, Research Nurses and Study Coordinators who work closely with Sponsors’ monitors. It will be particularly helpful for those personnel who are responsible for entering data in Case Report Forms.
Content
· ICH GCP and its relation to data integrity
· The drug development process and its relevance to data management
· Overview of process of data collection in a clinical trial
· The role of data management in trial design and conduct
· The impact of data quality on the outcome of a clinical trial
· Definition of source data
· The role of a clinical research monitor
· Various approaches to monitoring
· Concepts in CRF design
· The impact of the eCRF
· Review of other data collection tools and their significance
· Common causes of data errors/queries and their prevention and mitigation
By the end of this course you will be able to:
· Describe the key steps of a typical clinical trial
· Summarise the process of data management during a clinical study
· Outline the regulatory background and its relevance to clinical data management
· Review data from the perspective of a Sponsor
· Describe some of the common causes of data errors
· Apply techniques for minimising data errors
Course format
This is a one day classroom course run by an experienced data management professional and a clinical research trainer. The course is highly interactive, workshop style and includes a variety of trainer input, case studies, group activities and personal reflection. Participants will be encouraged to interact with each-other, contribute to class discussions and share their experiences.
Online Booking
This course will be held at Institute of Clinical Research, Bourne End
Please view our terms and conditions before proceeding with your booking
Price: £570
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Price: £570
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