Helpful links & docs

SA GCP Guideline

Ethics in Health Research Principles, Processes and Structures, Department of Health 2015, 2^nd Edition

Medicines and Related Substances Act 101 (SA)

Medical Devices and in vitro diagnostics (SA)

Emergency Procedures at Clinical Trial Site Nov15 V1 (includes Emergency Trolley Requirements Jun15 V1)

DOH NH Act 2003_Import export human tissue

EXPORT PERMIT BIOLOGICAL

IMPORT PERMIT BIOLOGICAL

International:

ICH GCP Guideline Amended

Declaration of Helsinki

EU Medical Device Regulations