The final six principles of GCP are:
- Research personnel qualification
- Voluntary informed consent
- Data integrity
- Confidentiality of records
- Drug manufacturing standards
- Quality assurance systems
Research personnel qualification
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
Voluntary informed consent
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
Confidentiality of records
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
Drug manufacturing standards
Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
Quality assurance systems
Researchers and institutions should assure quality of every aspect of the trial.