Change in procedure competent authority

As competent authority, the CCMO has the task to check the European adverse reactions database, EudraVigilance, for suspected adverse reactions, for each primary submission of research with a medicinal product. Without full knowledge of the research file, however, it is difficult for the competent authority to determine whether a reported SUSAR is actually an unexpected adverse reaction.

For this reason, the competent authority will change its procedure. If SUSARs are found in EudraVigilance that were reported by the sponsor after the date of the Investigator's Brochure (data lock point), the findings from EudraVigilance will be fed back to the submitter. The submitter is provided with a list of the SUSAR codes of the SUSARs found in EudraVigilance and is requested to inform the reviewing MREC of all suspicions of unexpected serious adverse reactions, which may be relevant for the risk assessment of the study by the reviewing MREC. This procedure will become effective as of 1 October 2018.