Common use of Reporting Adverse Events Clause in Contracts

Reporting Adverse Events. “THE INSTITUTE” and “THE INVESTIGATOR” must report events that, according to the Official Mexican Regulation NOM-220-SSA1-2016, Installation and operation of pharmacovigilance, Guidelines of the “International Conference on Harmonisation (ICH)” and Good Clinical Practice, as well as “THE PROTOCOL”, are considered as serious or non-serious adverse events, from baseline and during the execution of the RESEARCH PROJECT or Protocol, without authorization to such effect being required by “THE SPONSOR”. These adverse events shall be reported within no more than (24) twenty-four hours after “THE INVESTIGATOR” and/or “THE INSTITUTE” have become aware of the event.

Reporting Adverse Events. “THE INSTITUTE” and “THE INVESTIGATOR” must report events that, according to the Official Mexican Regulation NOM-220-SSA1-2016, Installation and operation of pharmacovigilance, Guidelines of the “International Conference on Harmonisation (ICH)” and Good Clinical Practice, as well as “THE PROTOCOL”, are considered as serious or non-serious adverse events, from baseline and during the execution of the RESEARCH PROJECT or Protocol, without authorization to such effect being required by “THE SPONSOR”. These adverse events shall be reported within no more than (24) twenty-four hours after “THE INVESTIGATOR” and/or “THE INSTITUTE” have become aware of the event.