Assess Feedback Follow-ups & Apply Learnings
Outcomes/Next Steps: Sponsor Stakeholders
Outcomes/Next Steps: Patient
Applied Learnings: Value Realization
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Outcomes/Next Steps: Sponsor Stakeholders
Outcomes/Next Steps: Sponsor Stakeholders
Outcomes/Next Steps: Patient
Applied Learnings: Value Realization
Outcomes/Next Steps: Sponsor Stakeholders
Scribe provides engagement output to sponsor team (compile raw data)
Review output with sponsor engagement team
- Ideally within first 2 weeks post-engagement
- Organize the engagement output for team use (Final Report), include insights and interpretations
- Determine suggested actions
- Consider regulatory impact
Disseminate final report to key sponsor stakeholders
- Ideally within 2 weeks post-sponsor engagement team review
- Evaluate suggested design changes and potential downstream impact
- Apply and document agreed-upon changes
- Track the impact of the patient engagement on key study performance indicators
Outcomes/Next Steps: Patient
Consider administering a Satisfaction Survey
- Timing dependent on engagement type
- The survey can be for the patient and study team
Show appreciation to the Patients for the support
- Ideally within 24-48 hours post engagement
Communicate back to the Patients
- Summarize where their feedback was utilized and/or how it influenced protocol design or other study elements (where appropriate)
- Consider to include where feedback could not be used, as appropriate, and the rationale
- Consider continuing to communicate with the patients throughout the lifecycle of the study, including awareness regarding why the study was discontinued early (as applicable)