RESOURCES
FURTHER READINGS ON GCP
Reading materials for self-learning. These are organized according to the standard curriculum of the GCP training under the following headings:
A. Good Clinical Practice GCP
B. Ethics of Clinical Research
C. Investigators’ & Sponsors’ Responsibility
A. GOOD CLINICAL PRACTICE GCP
No. | Author(s) | Title | Publication-Year |
01. | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) | Guideline for Good Clinical Practice GCP | 1996 |
02. | National Committee for Clinical Research NCCR | Malaysian GCP Guideline (4rd Edition) | 2018 |
03. | International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) Current Step 2 version |
2015 |
04. | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) |
Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) Current Step 4 version |
2016 |
B. RESEARCH ETHICS
No. | Author(s) | Title | Publication-Year |
01. | Anon | Nuremberg Code | 1949 |
02. | World Medical Association | Declaration of Helsinki. As amended by the 52nd World Medical Assembly, Seoul | October 2008 |
03. | Council for International Organizations of Medical Sciences | International Ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS, 1993This document can be found here:http://www.cioms.ch/publications/layout_guide2002.pdf | 1993 |
04. | Anon | Belmont report: Ethical Principles and Guidelines for the Protection of human subjects of research. | Washington DC: US Government Printing Office, 1978. |
05. | Emanuel, Wendler, Grady | What makes clinical research ethical? | JAMA 2000. |
06. | Ellis W. Lader et al | The Clinician as Investigator : Participating in Clinical Trials in the Practice Setting | Journals of the American Heart Assoc. 2004 |
07. | Henry Silverman | Ethical issues during the conduct of clinical trials | American Thoracic Society Journal 2007 |
08. | Michael Sharp | Common problems with informed consent in clinical trials | Research practitioner 2004 |
09. | Martin H N Tattersall | Examining informed consent to cancer clinical trials | Lancet 2001 |
10. | M. Lou Palladino | Challenges in the informed consent process: Identifying design strategies that enhance communication in adult clinical trials | Research Practitioner |
11. | Donal P.O Mathuna | Ethical Issues surrounding the conduct of research with decisionally impaired adults | Research Practitioner |
12. | Daniel W. Fitzgerald et al | Comprehension during informed consent in a less-developed country | The Lancet 2002 |
13. | Michael Sharp | Can vulnerable patients ever freely volunteer? | GCP Journal 2004 |
14. | Alan M. Sugar | Ethical challenges that accompany conducting research in children | Research practitioner 2005 |
15. | Nylenna M. | Scientific misconduct: a new approach for prevention. | Lancet 2006 |
16. | Christine Laine et al | Clinical trial registration: looking back and moving ahead | CMAJ 2007 |
C. INVESTIGATORS’ & SPONSORS’ RESPONSIBILITY
No. | Author(s) | Title | Publication-Year |
01. | Molly Matthews | Best practices in patient enrollment | Research Practitioner 2005 |
02. | Guy P.Johnson | Five Ideas to make a Research Site More Friendly | Monitor 2006 |
03. | Lynn Ransom | Completing site start-up activities within expected timelines | Research Practitioner 2006 |
04. | Teresa G. Joshi et al | Bridging the clinical trial recruitment leap | Research Practitioner 2002 |
05. | Janos Demeter | Selecting Sites and Investigators | Applied Clinical Trials 2002 |
06. | Stephen Evans et al | Societal responsibilities of clinical trial sponsors | BMJ 2001 |
07. | Anna J. DeMarinis | Sponsor inspections: What, why and how | Research Practitioner |
Disclaimer:
CReST EvendZ is not responsible for the content of external sites