Ethical and regulatory aspects Ethics committee The clinical trial will not be started before favourable opinion of the competent ethics committee. At each trial site the clinical trial will not be initiated unless favourable opinion has been given concerning the suitability of the trial site and the qualification of the principal investigator and his/her deputy. Ethical considerations The present trial protocol and any amendments were and will be prepared in accordance with the principles of the Declaration of Helsinki. If necessary, critical ethical aspects of the clinical trial should be discussed again here. Legislation and guidelines The present clinical trial will be conducted in accordance with the principles of the guidelines for Good Clinical Practice (ICH-GCP) and applicable legislation. principles cover, amongst other aspects, ethics committee procedures, the obtaining of informed consent from trial subjects, adherence to the trial protocol, administrative documentation, documentation regarding the IMP, data collection, trial subjects’ medical records (source documents), documentation and reporting of adverse events (AEs), preparation for inspections and audits, and the archiving of trial documentation. All principal investigators and other staff involved in the trial will be informed that local and national competent authorities as well as competent authorities from foreign countries and authorised representatives of the sponsor have the right to review trial documentation and the trial subjects’ medical records at any time. Notification of the authorities, approval and registration Before the start of the clinical trial, all necessary documentation will be submitted to the competent authority for approval (Federal Institute for Drugs and Medical Products,
Ethical and regulatory aspects Ethics committee The clinical trial will not be started before favourable opinion of the competent ethics committee. At each trial site the clinical trial will not be initiated unless favourable opinion has been given concerning the suitability of the trial site and the qualification of the principal investigator and his/her deputy. Ethical considerations The present trial protocol and any amendments were and will be prepared in accordance with the principles of the Declaration of Helsinki. If necessary, critical ethical aspects of the clinical trial should be discussed again here. Legislation and guidelines The present clinical trial will be conducted in accordance with the principles of the guidelines for Good Clinical Practice (ICH-GCP) and applicable legislation. principles cover, amongst other aspects, ethics committee procedures, the obtaining of informed consent from trial subjects, adherence to the trial protocol, administrative documentation, documentation regarding the IMP, data collection, trial subjects’ medical records (source documents), documentation and reporting of adverse events (AEs), preparation for inspections and audits, and the archiving of trial documentation. All principal investigators and other staff involved in the trial will be informed that local and national competent authorities as well as competent authorities from foreign countries and authorised representatives of the sponsor have the right to review trial documentation and the trial subjects’ medical records at any time. Notification of the authorities, approval and registration Before the start of the clinical trial, all necessary documentation will be submitted to the competent authority for approval (Federal Institute for Drugs and Medical Products,
Trial_Protocol_Template_V08.docx