- Protocol Writing Technology
- Protocol Builder® reinforces best practices for developing clinical research protocols taught by CITI Program. This secure cloud-based technology helps ensure quality and consistency so protocols can move through internal and IRB review processes more efficiently. Special pricing is available to CITI Program organizational subscribers. Sign up for a free trial.
- Regulatory Binder Tabs
- The set of regulatory binder tabs help principal investigators (PIs) and research teams organize the information that is required to be retained in the course of their clinical research study. While some may use electronic systems or a mix of paper and electronic systems, it is very beneficial to have a central “repository” that details where and how everything can be found. Download the regulatory binder tabs on our Resources page.
- Overview of ICH E6 (R2) Revisions
- 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. Download the overview on our Resources page.
Back to April 2017 Newsletter