Report of adverse events occuring during clinical trials („clinical report of adverse effects”)
Regulations concerning participants are the following:
Investigator
The sponsor has to be informed immediately about all serious adverse events by the investigator. After this notification a detailed written report has to be prepared and sent. Both the notification and the report have to contain the identification code of the participant.
The investigator has to inform the institutional Committee on the Ethics about the above mentioned facts and if required more information has to be given.
Sponsor
In Hungary all cases with Suspected Unexpected Serious Adverse Reaction (SUSAR) have to be reported to the National Institute of Pharmacy, to the Medical Research Council Ethics Committee for Clinical Pharmacology, to the EMEA, and in case of a multi-centered clinical trial to all investigators.
Deadline of sending the report: within 7, or 15 calendar days (lethal, life-threatening, or other serious, unexpected adverse effects) after acknowledgement.
In case of duble-blind tests any serious, unexpected events have to be reported urgently only if the relation between the experienced side effect and the examined preparation becomes clear after breaking the patient's code. Otherwise the case should be described in the final report and - during marketing of the medicinal product - in the Periodic Safety Update Report.
Consequential report has to be prepared if - in comparison with the previous report - any impotortant, new information becomes known.
Once a year a report should be sent to the National Institute of Pharmacy and to Medical Research Council Ethics Committee for Clinical Pharmacology during the clinical trial which has to include all serious adverse effects experienced and the estimation of the examined preparation concerning the risk-benefit rate.
National Institute of Pharmacy
Responsible for recording the reports on the serious, unexpected adverse effects.
Ethical Committees
Reports are handled according to own regulations of Medical Research Council Ethics Committee for Clinical Pharmacology.
