The need for 'good clinical practice' in health care research

Md Haris Robson Noorzurani, Noorazah Abd Aziz, Aznida Firzah Abdul Aziz, Mohd Z. Abd Hamid, Mohamed Mohamed, Sajaratulnisah Othman, N. Hussein

Research output: Contribution to journalArticle

Abstract

Randomised controlled trials form the foundation for 'evidence-based-medicine', but the results of such research can be relied upon only if it was conducted according to principles and standards collectively referred to as 'Good Clinical Practice' (GCP). The GCP was established as a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of research findings. It provides a framework for clinical investigators and pharmaceutical companies to conduct clinical trials according to similar rules and regulations, to ensure clinical research is consistently performed to high ethical and scientific standards and an assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Thus the GCP protects the rights, safety and well-being of subjects and ensures that investigations are scientifically sound and advance public health goals.

Original languageEnglish
Pages (from-to)202-205
Number of pages4
JournalSouth African Family Practice
Volume51
Issue number3
Publication statusPublished - 2009

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Health Services Research
Research
Evidence-Based Medicine
Confidentiality
Documentation
Randomized Controlled Trials
Public Health
Research Personnel
Clinical Trials
Safety
Pharmaceutical Preparations

Keywords

  • Ethical
  • GCP
  • Good clinical practice
  • Health
  • Research

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Noorzurani, M. H. R., Abd Aziz, N., Abdul Aziz, A. F., Abd Hamid, M. Z., Mohamed, M., Othman, S., & Hussein, N. (2009). The need for 'good clinical practice' in health care research. South African Family Practice, 51(3), 202-205.

The need for 'good clinical practice' in health care research. / Noorzurani, Md Haris Robson; Abd Aziz, Noorazah; Abdul Aziz, Aznida Firzah; Abd Hamid, Mohd Z.; Mohamed, Mohamed; Othman, Sajaratulnisah; Hussein, N.

In: South African Family Practice, Vol. 51, No. 3, 2009, p. 202-205.

Research output: Contribution to journalArticle

Noorzurani, MHR, Abd Aziz, N, Abdul Aziz, AF, Abd Hamid, MZ, Mohamed, M, Othman, S & Hussein, N 2009, 'The need for 'good clinical practice' in health care research', South African Family Practice, vol. 51, no. 3, pp. 202-205.
Noorzurani MHR, Abd Aziz N, Abdul Aziz AF, Abd Hamid MZ, Mohamed M, Othman S et al. The need for 'good clinical practice' in health care research. South African Family Practice. 2009;51(3):202-205.
Noorzurani, Md Haris Robson ; Abd Aziz, Noorazah ; Abdul Aziz, Aznida Firzah ; Abd Hamid, Mohd Z. ; Mohamed, Mohamed ; Othman, Sajaratulnisah ; Hussein, N. / The need for 'good clinical practice' in health care research. In: South African Family Practice. 2009 ; Vol. 51, No. 3. pp. 202-205.
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