Patient Protocol Engagement Toolkit

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)

Applied Learnings: Value Realization