E6: Safety Information

Question 1

5.16 - Safety Information

5.16.1

Answer 1

The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).

Question 2

Safety Information

5.16.2

Answer 2

The sponsor should promptly notify all concerned investigator(s)/institution(s) and the regulatory authority(ies) of findings that could affect adversely the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC’s approval/favourable opinion to continue the trial.

Question 3

5.17 Adverse Drug Reaction Reporting

5.17.1

Answer 3

The sponsor should expedite the reporting to all concerned investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the regulatory authority(ies) of all adverse drug reactions (ADRs) that are both serious and unexpected.

Question 4

Adverse Drug Reaction Reporting

5.17.2

Answer 4

Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

Question 5

Adverse Drug Reaction Reporting

5.17.3

Answer 5

The sponsor should submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s).