A Guide to GCP for Clinical Data Management Book

A Guide to GCP for Clinical Data Management Book
Product Code: A Guide to GCP for Clinical Data Management Book
Availability: In Stock
Price: £8.95

50 or more £7.75
100 or more £6.95
250 or more £5.95
500 or more £4.95
1000 or more £3.95

PLEASE NOTE: If you are booking for more than one participant or on behalf of someone else within your organisation you will be required to complete an 'Online Course Registration' form which can be downloaded by clicking here. Please ensure you click the 'Send to Brookwood Academy by E-mail' button at the bottom left of the form once completed. Failing to complete the form will cause delays in processing your order

Qty:     - OR -   Add to Wish List
Add to Compare

A brand new book for data management teams. Written by experienced head of data management, Mark Elsley, in conjunction with Professor David Hutchinson.
 This book covers the key ICH GCP E6(R2) requirements relevant to members of the data management team. It also provides valuable practical advice gained from the author’s extensive experience in this field.


Content is based on a GCP checklist providing more detail on the following general requirements
• Ensure that staff are suitably qualified and trained
• Create, maintain and follow sops describing the clinical data management processes
• Validate and control all computerized systems used to collect and handle clinical data
• Ensure that the flow of data from the source to the database is well documented
• Ensure that source data meet ALCOA+ standards
• Create a user-friendly CRF and database
• Check CRF data for accuracy, consistency and completeness
• Produce, maintain and archive high-quality documentation
• Ensure that CROs are suitably qualified and experienced
• Use a risk register at functional and study level
• Have input into risk-based approaches to trial management

The book includes a GCP checklist for clinical data management

Write a review

Your Name:

Your Review: Note: HTML is not translated!

Rating: Bad           Good

Enter the code in the box below:

Powered By OpenCart
Brookwood Global © 2020