Good clinical practice, a transparent way of life. A review.
Investigators are regarded as central to the concept of clinical trials. Apart from bearing scientific responsibility, they will be confronted with a great number of ethical dilemma's concerning, amongst others, the justification and design of the trial, subject selection and informed consent, and presentation of the trial results. The ethical principles of biomedical research should be observed in accordance with a consistent moral code. The moral code of Good Clinical Practice (GCP) was developed in order to rule out inconsistencies. The principal tenets are that clinical trials should be good science, verifiable, monitored, well documented, and that they comply with the highest ethical standards. The principles of GCP are the protection of the rights of human subjects, integrity and reproducibility of data, and transparency of conduct.
van Dongen
A J
AJ
Department of Nuclear Medicine, Division of Radiology, Radiotherapy and Nuclear Medicine, University Medical Center Utrecht, E 02.222, P.O. Box 85500, 3508 GA Utrecht, The Netherlands. alicej.vandongen@azu.nl
D002986:Clinical Trials as Topic / Q000592:standards*; D004992:Ethics, Medical; D005060:Europe; D019983:Guideline Adherence; D006801:Humans; D007258:Informed Consent; D007564:Japan; D018579:Patient Selection; D010818:Practice Patterns, Physicians' / Q000592:standards*; D012107:Research Design / Q000592:standards*; D014481:United States