ICH - International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
GCP - Good Clinical Practice
ICH-GCP guidelines are internationally recognized ethical and scientific standards for designing, conducting, recording, and reporting clinical trials involving human participants. They ensure the protection of trial subjects and the credibility of clinical data.
Here are the 13 Core-Principles of ICH-GCP Guidelines:
The latest version E6(R3), was adopted from January, 2025, which also builds on earlier versions R1 and R2.
- Ethical conduct of clinical trials according to the declaration of Helsinki
- The Rights, Safety and Well-being of the trial participants are paramount
- Risks must outweigh anticipated benefits
- Adequate nonclinical and clinical information is available
- Scientifically sound protocol
- Prior approval from Institutional Ethics Committee (IEC)
- Qualified personnel to be employed for medical care and trial decisions
- Informed consent to be obtained from every participant
- Data integrity
- Confidentiality of trial records
- Good manufacturing practice of the investigational products
- Quality in the conduct of the trial
- Compliance with the protocol
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