The Global Health Network is proud to announce the launch of a new e-learning short course; How to Conduct GCP Inspections/Audits at the Clinical Investigator Site: https://globalhealthtrials.tghn.org/elearning/education/elearning-courses/how-to-conduct-gcp-inspectionsaudits-at-the-clinical-investigator-site/1546/
This course is intended to benefit regulatory good clinical practice (GCP) inspectors and sponsor auditors who audit clinical trials and in particular:
1. regulatory authorities or sponsors in the process of building up their GCP inspection/audit team and an inspection/audit programme
2. regulatory authorities or sponsors which require further, up to date training in the planning, conduct and reporting of GCP inspections/audits for their inspection/audit team.
This course describes the procedures involved in planning, conducting and reporting inspections/audits, specifically at clinical investigator sites. However, some of the general principles described could be used when conducting inspections at other sites e.g. those of the sponsors and contract research organisations (CRO).
The course should take no more than 30 to 45 minutes to complete and it is recommended that before commencing this course, participants may find it valuable to complete the course ‘ICH Good Clinical Practice’ also available for free from The Global Health Network eLearning Centre: http://globalhealthtrials.tghn.org/elearning/other-resources/
There is the possibility for this course to be offered as a face to face training course in conjunction with an onsite national inspection at a clinical investigator site. This would provide the opportunity to gain hands-on experience in the conduct of an inspection by implementing the theoretical aspects of the course, into real life practice. For further information and details please contact firstname.lastname@example.org