Safety Reporting. Institution and Investigator will report all serious adverse events,, special situation reports and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC and European Union Regulation EU No 536/2014. For the avoidance of doubt, each of the Investigator and the Institution will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements.
Appears in 1 contract
Samples: Clinical Trial Agreement
Safety Reporting. Institution and and/or Investigator will report all serious adverse events,, special situation reports reports, and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-ICH- E2A and the European Union Directive 2001/20/EC and European Union Regulation EU No 536/2014. For the avoidance of doubt, each of the Investigator and the Institution will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements.
Appears in 1 contract
Samples: Clinical Trial Agreement
Safety Reporting. Institution Provider and Investigator will report all serious adverse events,, special situation reports reports, and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-ICH- E2A and the European Union Directive 2001/20/EC and European Union Regulation EU No 536/2014. For the avoidance of doubt, each of the Investigator and the Institution Provider will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements.. 1.10
Appears in 1 contract
Samples: Clinical Trial Agreement
Safety Reporting. Institution and Investigator will report all serious adverse events,, special situation reports ,and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-E2A and the European Union Directive 2001/20/EC and European Union Regulation EU No 536/2014. For the avoidance of doubt, each of the Investigator and the Institution will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements.
Appears in 1 contract
Samples: Clinical Trial Agreement
Safety Reporting. Institution and Investigator will report all serious adverse events,, special situation reports reports, and other safety concerns as specified in the Protocol and in accordance with applicable laws, rules and regulations, including, but not limited to ICH-ICH- E2A and the European Union Directive 2001/20/EC and European Union Regulation EU No 536/2014. For the avoidance of doubt, each of the Investigator and the Institution will provide all reasonable assistance to Gilead to allow Gilead to comply with all applicable requirements.
Appears in 1 contract
Samples: Clinical Trial Agreement