Free Resources on Final Rule Revisions
CITI Program has developed resources to help the research community understand the revisions to the Common Rule before they take effect in January 2018. They include overviews, handouts, and presentations developed by expert authors and reviewed by peers.
VIEW FINAL RULE RESOURCES
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.
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.
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Regulatory Binder Tabs
This set of regulatory binder tabs is intended to 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 you 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.
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HRP Consulting Group (HRP): Research and Ethics Consulting
With over 150 years of combined experience in human research protections, HRP provides services including the development of human research protections programs, training and education, assistance with accreditation, IRB administration and auditing.