Clinical Trials in Belgium: The Implementation of the European Clinical Trials Directive 2001/20/EC Into the Belgian Law of May 7, 2004 Concerning Experiments on the Human Person : Operational GuidanceIntersentia nv, 2004 - 258 pages In line with its strong position in clinical research, Belgium is one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the new law concerning experiments on the human person (May 7, 2004) reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. At its request, dr. iur. Caroline Trouet wrote an Operational Guidance, which analyses the new Belgian law from the perspective of the sponsor of a clinical trial, but addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials in the practical implementation of the new law, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added. The text is useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators etc.; by those who have had access to the manuscript, it is already qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law. |
Contents
BELGIUM AS A HOST COUNTRY FOR CLINICAL TRIALS | 3 |
OPERATIONAL GUIDANCE | 14 |
Informed consent | 19 |
CLINICAL TRIALS | 21 |
GENERAL PROVISIONS CONCERNING THE PROTECTION | 27 |
SPECIFIC PROVISION FOR THE PROTECTION | 35 |
OBTAINED DUE TO EMERGENCY | 42 |
1 | 50 |
VERIFICATION OF COMPLIANCE WITH GCP AND GMP | 111 |
NONINTERVENTIONAL TRIALS | 115 |
EXPERIMENTS FALLING UNDER THE | 130 |
INTERNET LINKS | 137 |
National clinical trial application | 152 |
Summary protocol French | 165 |
Curriculum vitae investigator | 182 |
Checklist of the information to be submitted | 191 |
PROCEDURES PRIOR TO THE BEGINNING OF | 63 |
PROCESS OF AUTHORIZATION AND ETHICAL REVIEW | 76 |
PROCEDURES DURING THE CONDUCT OF | 86 |
PROCEDURES AT THE END OF AN EXPERIMENT | 97 |
MANUFACTURE IMPORT AND DISTRIBUTION | 105 |
Royal Decree of June 30 2004 providing | 211 |
Royal Decree of July 15 2004 establishing | 237 |
Example of the contents of a full investigational | 247 |
Example of the contents of an investigators | 254 |
Common terms and phrases
2004 inzake experimenten aanvraag adverse reactions andere Annex Arrêté royal Article 11 autre Etat Belgian Belgium betreffende bevoegde bonnes pratiques clinical trial application Clinical Trials Directive clinique competent authority conformément coordinating investigator Decree of June Detailed guidance documents dossier ethics committee EudraCT number European Clinical Trials European Union européenne Europese Unie gedetailleerde gegevens Gelet gene therapy geneesmiddelen voor onderzoek genetically modified organisms hospital human person indien informed consent investigational medicinal products investigational product investigator's brochure issue the single koninklijk besluit kunnen l'article ligne directrice détaillée manufacturing manufacturing practice marketing authorization médicaments expérimentaux mei 2004 inzake Member menselijke persoon minister n-LEC notification of substantial notified opdrachtgever participate partij patient présent arrêté procedures product for human proeven promoteur protocol referred relative aux expérimentations request richtsnoeren Royal Decree single opinion sponsor substantial amendments Template UCB Pharma usage humain visée wordt zijn