Good Clinical Practice (GCP): A review
Keywords:
CROs, Managing trial data, Clinical Trials, GCP
Abstract
Good Clinical Practice (GCP) is an international ethical and scientific quality standard designed to conduct, performance, monitor, audit, record, analyse and report clinical trials. It protects the rights, integrity and confidentiality of trial subjects. Clinical research trails are increasingly playing a role in various medical disciplines. GCP guidelines are used in clinical trials through out the globe with the main aim of protecting and preserving human rights. In this review article the historical background and the events that led up to the formation of these guidelines, key trial activities and principles of GCP are discussed.
References
1. Handbook for good clinical research practice(GCP): Guidance for implementation, 2002, 3- 20
2. Vijayananthan A, Nawawi O: The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J, 2008, 4(1):e5
3. Otte A, Maier-Lenz H, Dierckx RA: Good Clinical Practice: Historical background and key aspects. Nucl Med Com 2005, 26:563-74.
4. Office of Human Subjects Research. The Nuremberg Code, 1949, ohsr.od.nih.gov/guidelines/nuremberg.
5. The Doctors Trial (the Medical Case of the Subsequent Nuremberg Proceedings), ushmm.org/research/doctors/Nuremberg_Code.htm.
6. The World Medical Association. Declaration of Helsinki, 2004, wma.net/e/policy/b3.htm.
7. Vadivale M: ICH-GCP Guidelines for Clinical Trials. Berita MMA. 1999, 7:29 8. ICH E6: Good Clinical Practice: Consolidated Guideline 1996. ich.org/
2. Vijayananthan A, Nawawi O: The importance of Good Clinical Practice guidelines and its role in clinical trials. Biomed Imaging Interv J, 2008, 4(1):e5
3. Otte A, Maier-Lenz H, Dierckx RA: Good Clinical Practice: Historical background and key aspects. Nucl Med Com 2005, 26:563-74.
4. Office of Human Subjects Research. The Nuremberg Code, 1949, ohsr.od.nih.gov/guidelines/nuremberg.
5. The Doctors Trial (the Medical Case of the Subsequent Nuremberg Proceedings), ushmm.org/research/doctors/Nuremberg_Code.htm.
6. The World Medical Association. Declaration of Helsinki, 2004, wma.net/e/policy/b3.htm.
7. Vadivale M: ICH-GCP Guidelines for Clinical Trials. Berita MMA. 1999, 7:29 8. ICH E6: Good Clinical Practice: Consolidated Guideline 1996. ich.org/
Published
2014-09-01
How to Cite
[1]
Shamim, B. 2014. Good Clinical Practice (GCP): A review. PharmaTutor. 2, 9 (Sep. 2014), 20-29.
Section
Articles
