data will likely result in a process that does not add value because of the potential high amount of cases that will be reported. For an issue occurring at a single investigator site for a single patient a Sponsor QMS root cause analysis and full-blown CAPA process do not make sense from a risk management perspective. The above approach negates the direction provided by ICH-GCP revision to have a risked based approach. Please clarify alignment with risk based approach as described in ICH E6 revision Specific comments on text Line number(s) of the relevant Stakeholder Comment and rationale; proposed changes Outcome text number (If changes to the wording are suggested, they should (To be completed (e.g. Lines 20-23) (To be be highlighted using 'track changes') by the Agency) completed by the Agency) §1 Legal Requirement Comment: :” 2. For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree Line 39 the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.” Proposed change (if any): Would rather state it as serious breach if it did affect to a significant degree… (cfr App II initial assessment : line 213 : question is whether the breach does affect to a significant degree the safety of subject etc…)
data will likely result in a process that does not add value because of the potential high amount of cases that will be reported. For an issue occurring at a single investigator site for a single patient a Sponsor QMS root cause analysis and full-blown CAPA process do not make sense from a risk management perspective. The above approach negates the direction provided by ICH-GCP revision to have a risked based approach. Please clarify alignment with risk based approach as described in ICH E6 revision Specific comments on text Line number(s) of the relevant text (e.g. Lines 20-23) Stakeholder number (To be completed by the Agency) Comment and rationale; proposed changes (If changes to the wording are suggested, they should be highlighted using 'track changes') Outcome (To be completed by the Agency) §1 Legal Requirement Line 39 Comment: :” 2. For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.” Proposed change (if any): Would rather state it as serious breach if it did affect to a significant degree… (cfr App II initial assessment : line 213 : question is whether the breach does affect to a significant degree the safety of subject etc…)
efpia-response_guideline-on-serious-breaches_300817final.docx