It is LSHTM policy that all clinical trials involving human participants follow the principles of Good Clinical Practice, as outlined in the ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996).
LSHTM has invested in robust quality assurance systems to ensure adherence to these and other research governance standards aided primarily through the employment of a Quality and Governance Manager. The Quality and Governance Manager regularly audits studies to assess and assure the reliability and integrity of a study’s quality control systems and are a way of measuring performance against recognised standards such as ICH GCP.
Standard Operating Procedures are available to help researchers at the School with all aspects of study processes including writing a protocol to standards detailed in GCP, informed consent, ethics approval and monitoring (quality control). Our team have been trained in GCP and Data Management. The courses are run by LSHTM by our Quality and Governance Manager who is a Trained Auditor by the British Association of Research Quality Assurance (BARQA) and has more than seven years experience as a GCP Trainer.