02. EU Commission Directive 2005/28/EC (UPDATED LINK)
03. EU Commission Directive 2003/94/EC (UPDATED LINK)
14. NIHR Clinical Trials Toolkit
15. MHRA Good Clinical Practice Guide (Grey Guide) (UPDATED LINK)
Click here to view the process that covers inspection types, routine inspection process flowchart, submissions, what to expect during routine inspections, findings and reporting of routine inspections, and triggered inspections.
US Department of Health and Human Services link to laws, regulations, and guidelines that govern human subjects research in 104 countries and the standards from several international and regional organisations. Click here.
The Japan Society of Quality Assurance (JSQA), the Society of Quality Assurance (SQA) and the RQA has published an agreed Global GCP Auditing Guideline and supplemental Appendices on many specific audit types, effective April 2014. This is a unique, collaborative effort between the three societies to provide our members with guidance and a best practice approach to GCP auditing across regions.
Click here to view an archived regulations and guidelines document - while this information is no longer updated and may not be the most current, it may be beneficial from a historical perspective.
RQA's Good Clinical Practice webpage Click here