title: [Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].
abstract: With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn. eckhardt@bfarm.de
authors.forename: K
authors.initials: K
authors.lastname: Eckhardt
authors.forename: P
authors.initials: P
authors.lastname: Cremer-Schaeffer
authors.forename: J
authors.initials: J
authors.lastname: König
authors.forename: N
authors.initials: N
authors.lastname: Paeschke
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D016208:Databases, Factual / Q000331:legislation & jurisprudence; D016903:Drug Monitoring; D015507:Drugs, Investigational / Q000009:adverse effects* / Q000627:therapeutic use; D017041:Ethics Committees / Q000331:legislation & jurisprudence; D005060:Europe; D005062:European Union; D005858:Germany; D019983:Guideline Adherence; D006801:Humans; D007391:International Cooperation; D007880:Legislation, Drug
chemical_list: D015507:Drugs, Investigational