The purpose of this document is to establish internal procedures for the identification and evaluation of consensus standards in research practice. Adherence to the principles of good clinical practice is universally recognized as a critical requirement to the conduct of human subject’s research. Although this study is not conducted in the US, The Food and Drug Administration (US FDA) regulations is used as guidance to assist clinical investigators in the assurance that the rights, safety, well-being and confidentiality of study participants are protected.
This standard operating procedure (SOP) describes the process and documentation required by this institution for the initial and ongoing education of the principal investigator and research staff in Good Clinical Practices (GCPs) and the ethical conduct of research conducted at our multi-center research sites.
Applicable References to SOPs, Regulations or Guidelines
21 CFR 312.60 General responsibilities of investigators
45 CFR 46 Protection of Human Subjects
21 CFR 812 Subpart E Responsibilities of Investigators
May 1997 ICH Good Clinical Practice: Consolidated Guideline (E6 4.2.4)
Feb 5, 2010 FDA Internal Compliance Program Guidance Manual for Clinical
Aug 25, 2000
NIH Notice OD-00-029: Required Education in the Protection of
Human Research Participants
Sept. 12, 2001 Clarification on June 5, 2000 Notice (OD-00-39)
All personnel must completed present training documentation in good clinical practices. The NIH online training and certificate link is as follows http://clinicalcenter.nih.gov/training/training/crt.html