TY - JOUR

T1 - Notification of suspected and unexpected serious adverse reactions according to the Clinical Trials Directive - A descriptive analysis of the legislation and the requirements in a European context

AU - Larsen, Ellen Frøsig Moseholm

AU - Grarup, Jesper

AU - Gey, Daniela Christine

AU - Jensen, Majken Karoline

AU - Kirk, Ole

PY - 2010/12

Y1 - 2010/12

N2 - The European Clinical Trials Directive (CTD) came into force on May 1st 2004. The CTD provides the legal basis for monitoring the safety of clinical trials and covers the requirements for notification of SUSAR. Implementation of the CTD into national legislation in each Member State has resulted in various interpretations of CTD requirements. The objective of this paper is to investigate how the European Member States administer the safety reporting requirements of the CTD and to clarify the requirements for SUSAR notification in the different Member States. Data was collected through publicly available sources and questionnaires sent to the Competent Authorities and Ethics Committees in 30 European countries. The results document that Competent Authorities and Ethics Committees in the different Member States administer the legislation very differently. This has resulted in different requirements for notification of SUSARs in the Member States, as well as different requirements between the Competent Authorities and Ethics Committees in the same Member State. These requirements have not previously been described and the present overview of the legislation and the requirements of SUSAR reporting is of immediate practical use to especially non-commercial sponsors when conducting clinical trials in Europe.

AB - The European Clinical Trials Directive (CTD) came into force on May 1st 2004. The CTD provides the legal basis for monitoring the safety of clinical trials and covers the requirements for notification of SUSAR. Implementation of the CTD into national legislation in each Member State has resulted in various interpretations of CTD requirements. The objective of this paper is to investigate how the European Member States administer the safety reporting requirements of the CTD and to clarify the requirements for SUSAR notification in the different Member States. Data was collected through publicly available sources and questionnaires sent to the Competent Authorities and Ethics Committees in 30 European countries. The results document that Competent Authorities and Ethics Committees in the different Member States administer the legislation very differently. This has resulted in different requirements for notification of SUSARs in the Member States, as well as different requirements between the Competent Authorities and Ethics Committees in the same Member State. These requirements have not previously been described and the present overview of the legislation and the requirements of SUSAR reporting is of immediate practical use to especially non-commercial sponsors when conducting clinical trials in Europe.

KW - Faculty of Health and Medical Sciences

KW - Clinical Trials Directive

KW - SUSAR

U2 - 10.3109/10601333.2010.507768

DO - 10.3109/10601333.2010.507768

M3 - Journal article

VL - 27

SP - 108

EP - 120

JO - Clinical Research and Regulatory Affairs

JF - Clinical Research and Regulatory Affairs

SN - 1060-1333

IS - 4

ER -