Good Clinical Practice (GCP) Regulations and Guidelines
QA Legislative Update
MHRA Good Clinical Practice: The Inspection Process
Click here to view the process which covers types of inspection, routine inspection process flowchart, submissions, what to expect during ruotine inspections, findings and reporting of ruotine inspections and triggered inspections.
International Compilation of Human Research Standards- 2013 Edition
US Department of Health and Human Services link to to laws, regulations, and guidelines that govern human subjects research in 104 countries, as well as the standards from a number of international and regional organisations. Click here.
The Global Guideline for GCP Audit
This guideline was completed based on global discussions among SQA, RQA and JSQA. The guideline includes the mission and the organisation of a sponsor's auditing department and establishes the principles for planning, performing and reporting audits. Click here for the latest version.
Regulations and Guidelines Archive 2009
Click here to view an archived regulations and guidelines document - while this information is not the most current, it may nonetheless be beneficial from a historical perspective.