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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 (3rd Edition)	2011
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