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 -
***** ICH GCP E6 (R2) compliant *****
by Prof David Hutchinson
The code of Federal Regulations (21 CFR Part 312) applies to all studies performed in accordance with an Investigational New Drug Application (IND) in the USA. In addition, Good Clinical Practice (GCP) is a global quality process that is applied to the conduct of all clinical trials on new medicinal products. Study investigators, including physicians and other healthcare professionals at all levels of experience, have GCP responsibilities, but most researchers do not full understand what this involves. Investigators who do not work in accordance with GCP will be unable to perform trials on new products in the future.
This quick and easy to read, illustrated, 'bullet point' guide to IND requirements and ICH GCP is ideal for investigators and other members of the study team.
This popular book will help investigators comply with ICH GCP investigator responsibilities and items on the monitor's wish list. The book contains relevant extracts from the guidelines.
It presents 15 golden rules for investigators and members of the study team who need to be aware of their responsibilities when performing a trial in accordance with the US Investigational New Drug (IND) application requirements (21CFR Part 312).