ICH-GCP Guidelines

Purpose and Scope

ICH Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving human subjects.

Compliance provides public assurance that the rights, safety, and well-being of trial subjects are protected and that trial data are credible.

Investigator Responsibilities

Investigators must be qualified by education, training, and experience and must comply with the protocol, GCP, and applicable regulations.

Adequate resources, including qualified staff and facilities, must be available for the duration of the trial.

Investigators are responsible for obtaining and documenting informed consent and for reporting adverse events per protocol.

Protocol and Data Integrity

The protocol must be scientifically sound, clearly written, and approved by IRB/IEC before implementation.

All trial data must be recorded, handled, and stored to permit accurate reporting and verification.

Source documents must be retained to enable reconstruction and evaluation of the trial.

Monitoring, Auditing, and Inspection

Trials should be monitored to verify compliance with protocol, GCP, and regulatory requirements.

Regulatory authorities may inspect trial sites; investigators must permit access to source data and documents.

Quality management systems should address protocol deviations and corrective actions.