FAQs |
How are clinical trial participants to be protected under the Regulations?
How are clinical trial participants to be protected under the Regulations?
The UK Regulations require that each trial has a sponsor who must obtain authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) and a favourable opinion of an ethics committee before the trial can commence. This gives assurance that the trial will not expose participants to unacceptable conditions or hazards. In addition, there will be a requirement that medicines used in trials are manufactured to standards of Good Manufacturing Practice (GCP) to prevent participants being exposed to unsafe medicines.