title: [European guideline for the quality of non-commercial clinical trials: elegant implementation in the Netherlands via the amended Dutch Medical Research Involving Human Subjects Act].
abstract: As of May 2004, the new European directive 2001/20/EC will require European member states to follow Good Clinical Practice rules for non-commercial academic clinical investigations. For several member states this poses a serious threat to such investigations. In the Netherlands however, most items of the new directive can be incorporated in the Dutch Medical Research Involving Human Subjects Act. In fact, many of the items are already covered by this Act, notably with respect to data integrity and patient safety. However, an extra effort is needed to implement the quality control standards to which the registration research already complies. The Dutch Medical Research Involving Human Subjects Act is currently being amended to comply with the new European directive. This is also an ideal opportunity for enhancing the national climate of clinical research and ensuring an improved translation of local research ideas into clinical trial protocols.
authors.affiliation: Centre for Human Drug Research, Zernikedreef 10, 2333 CL Leiden. ac@chdr.nl
authors.forename: A F
authors.initials: AF
authors.lastname: Cohen
mesh_terms: D002985:Clinical Protocols; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D005062:European Union; D006801:Humans; D009426:Netherlands; D017410:Practice Guidelines as Topic / Q000592:standards*; D011787:Quality of Health Care; D036302:Therapeutic Human Experimentation / Q000331:legislation & jurisprudence*