When we talk about medical or clinical research, Good Clinical Practice is usually referred to the pivotal idea of compliance with certain regulations, guidelines, rules and laws which serve to ensure quality of data and guarantee for the well-being of the participants in a specific trial. In order to outline the importance of ICH-GCP, here we are listing 13 core principles:
1. Conduct trials according to:
- Ethical principles from DoH,
- Consistent with GCP
- Applicable regulatory requirement(s)
2. Before initiating, weigh risks against benefit (participant and society).
3. Rights, safety, and well-being of trial subjects prevail over interests of science and society.
4. Adequate nonclinical and clinical information on investigational product to support proposed trial.
5. Scientifically sound clinical trial; clear, detailed protocol.
6. RB-approved protocol (for Cosmetic studies)
- Should seek EC approval if invasive or presents residual risk to subjects
- Not required for acceptability testing
- Approval per study; not per design
7. Medical decisions – responsibility of a qualified physician.
- Examinations for cosmetics may be by other professional experts
8. Each team member should be qualified by education, training, and experience for his/her trial tasks.
- appropriate qualifications;
- training and experience in the field of the proposed study; and
- respected for ethical quality and professional integrity.
9. Freely given informed consent from every subject prior to participation.
10. Storage, recording and handling of all clinical trial info such that it is accurately reported, interpreted and verified.
- Allow full reconstruction of sampling procedures that were applied
11. Protect confidentiality of records; respect applicable privacy and confidentiality rules.
- e.g, UK’s Data Protection Act (1998), regulated and enforced by ICO
12. GMP manufacturing , handling and storage of IP. Use in accordance with approved protocol.
- Cosmetic test samples generally no full GMP. But full manufacturing process to be able to be reconstructed
13. Implement quality systems and procedures to assure the quality of every aspect of trial.
If you would like to upgrade your knowledge or you need to be certified specialist, you might consider to take our GCP course. Learn more here:Online Courses
