The final six principles of GCP are:

  1. Research personnel qualification
  2. Voluntary informed consent
  3. Data integrity
  4. Confidentiality of records
  5. Drug manufacturing standards
  6. 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.

Data integrity

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.