Course Code: 9160CT204

Course Title: Regulatory affairs, good clinical practice and ethics

College: LSHTM

Course Director: Kendall Searle

Course Description: This module will cover the regulatory legislation and associated approvals and permissions required to conduct high-quality single-centre, national and international clinical trials. Integral to the legislation is Good Clinical Practice (GCP). You will gain a solid understanding of GCP and will explore ways of implementing GCP, including risk assessment and trial monitoring. A variety of clinical and geographical settings will be examined. Ethical issues will be considered throughout the module.

Assessment: Exam 80% - Written Assignment(s) 20%

Course Credit: All LSHTM Short Courses offer transfer of credit to LSTHM Certificate, Diploma or Masters-level programmes within 4 years of completion

Course Study Hours/Duration: 100 hrs over 35 weeks

Schedule of Availability: Oct - June (Enrolment deadline prior to Oct start - 30th June)

Delivery Mechanisms: Online VLE; CD-ROM

Cost: £857

How to apply: To enquire about applying for this course, or for any other information, please contact the Course Administrator using the online Enquiry Form below