In accordance with
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (article 17) (pdf)
- Detailed guidance on the collection, verification and presentation of Adverse Reaction Reports arising from clinical trials on medicinal products for human use (pdf)
Responsibilities
The investigator shall report all Serious Adverse Events (SAEs) immediately to the sponsor except for those that the protocol or investigator’s brochure identifies as not requiring immediate reporting.
The sponsor is responsible for the prompt notification to all concerned investigator(s), the
Ethics Committee and Competent Authority of each concerned Member State of findings that could adversely affect the health of subjects, impact on the conduct of the trial or alter the competent authority’s authorisation to continue the trial in accordance with Directive 2001/20/EC.
The sponsor is responsible for arranging structures and written standard operating procedures to ensure that the necessary quality standards are observed in every step of the case documentation, data collection, validation, evaluation, archiving and reporting.
Notification of serious adverse reactions
The sponsor shall ensure that all relevant information about suspected unexpected serious adverse reactions (SUSARs) that are fatal or life-threatening is recorded and reported as soon as possible to the competent authorities in all the Member States concerned, and to the Ethics Committee, and in any case no later than seven days after knowledge by the sponsor of such a case and that relevant follow-up information is subsequently communicated within an additional eight days.
All other suspected serious unexpected adverse reactions (SUSARs) shall be reported to the competent authorities concerned and to the Ethics Committee concerned as soon as possible but within a maximum of fifteen days of first knowledge by the sponsor.
SUSARs recorded outside Norway shall be reported to the Norwegian Medical Agency only once a year.
Once a year throughout the clinical trial, the sponsor shall provide the Member States in whose territory the clinical trial is being conducted and the Ethics Committee with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects' safety.