Regulation 35 Annual ... safety reportF7

the records of, and evaluation relating to, any serious adverse reactions and serious adverse events which have occurred during the reporting year, including suspected unexpected serious adverse reactions, kept or conducted under regulation A32;

the record of the taking of any measures referred to in regulation A32(2)(b);

a description of how any safety concerns in the clinical trial have been assessed and managed; and

a description of the overall safety profile of each investigational medicinal product being tested or used in the trials referred to in regulation A32(1), as well as a summary description of the processes adopted by the sponsor to monitor the overall safety profile of those products.

which emerge from the report under paragraph (1); or

which have otherwise come its attention, and raise concerns about the safety of the trial or the participants.

in the case of a product which has a marketing authorization, the earliest date on which any such authorization relating to that product was granted or issued; or

in any other case, the earliest date on which any clinical trial—

was authorised in an F4any country.

the date on which the trial was authorised by a regulatory body responsible for authorising clinical trials in that country; or

where the clinical trial was conducted in a country without a formal authorisation process, a date designated by the sponsor that is linked to the commencement of the first clinical trial.