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 (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

 

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'A theory is something nobody believes, except the person who made it. An experiment is something everybody believes, except the person who made it.'


Albert Einstein
Nobel Prize Laureate (Physics)