Overview: ICH GCP E6(R2) Integrated Addendum
On 15 December 2016, the International Council for Harmonistion (ICH) adopted the revised E6 guideline. Now, regulatory implementation is carried out according to the same national/regional procedures that apply to other regulatory guidelines and requirements. This resource answers question about the guideline and provides a breakdown of the revisions by section.
Are You Thinking About Being in a Research Study?
Before deciding to participate in a research study, you should learn about what to expect and where to find more information. This resource covers subject’s rights, questions that should be asked about the study, informed consent, and definitions of commonly used terms.