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 orderQty: - OR -
A brand new online training course for data management teams.
The online, on demand training with a quiz and certification is a fun interactive way for data management personnel to learn about their GCP responsibilities.
The training covers the key ICH GCP E6(R2) requirements relevant to members of the data management team. They also provide valuable practical advice gained from the author’s extensive experience in this field.
Content is based on the GCP checklist …..
• 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
• GCP checklist for clinical data management
Course Running time: Narrated version approx 60 minutes including certification quiz
A book to go with the with the online training, written by experienced Head of Data Management, Mark Elsley, in conjuction with Professor David Hutchinson, is also available.
Visit www.canarybooks.com for further details, to see page spreads and to order online.
Contact us for more details of pricing for groups of more than 5 participants.