• QSP SIG Working Group Survey QSP Model Credibility and Regulatory Use

  • Goal and Scope

    This survey aims to collect cross-industry perspectives on current practices for the execution and reporting of credibility assessments of QSP models intended for regulatory use.

    For the purposes of this survey, model credibility assessment refers to model evaluation activities used to determine whether a QSP model is physiologically reasonable, scientifically relevant, and fit for its intended context of use. Consistent with ICH M15 principles, these activities should be guided by the question of interest, intended use, and the risk and impact of the model-informed decision. The survey addresses how credibility assessments are implemented, documented, communicated, and reported for internal and regulatory purposes.

    Please answer based on your own first-hand experience and, where appropriate, your understanding of practices within your organization or QSP function. Responses may reflect individual project experience, broader organizational practices, or collective team experience. Please do not include confidential, proprietary, patient-level, or otherwise sensitive information.

    The survey covers methodological approaches, documentation standards, model evaluation strategies, communication practices, and alignment with regulatory guidance and expectations. It also explores internal stakeholder alignment, governance models, and cross-functional decision processes that influence whether and how QSP evidence is incorporated into regulatory strategies.

    The survey will be open from August 12 to October 17. The findings will be analyzed in aggregate, and individual respondents will not be identified in any outputs. Survey data will be accessible only to the organizers/analysis team and used solely to identify trends, areas of convergence or divergence, and opportunities to strengthen best practices in credibility assessment and regulatory communication of QSP models.

     

  • 1. Respondent and Organizational Context

  • What is your organization type? Please enter your function (e.g., Clinical Pharmacology)
  • What stages do your QSP models typically support? Select all that apply.
  • Have you used QSP models in regulatory interactions or submissions?
  • How would you characterize your organization's regulatory QSP maturity?
  • Does your company provide any training or onboarding materials related to regulatory use of QSP modeling?
  • What types of QSP modeling training are currently available within your organization? Select all that apply.
  • Who is the primary audience for QSP modeling training? Select one.
  • Does the training include regulatory communication of QSP modeling results? Select one.

  • 2. Regulatory Use Cases and Context of Use

  • For what regulatory purpose has QSP models been used. Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely (
    Rows
  • For which therapeutic areas have QSP been used in regulatory interactions? Select all that apply
  • At what development stages has QSP been used specifically in regulatory interactions? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely (
    Rows

  • 3. Regulatory Interaction and Submission Pathways

  • In which regions have QSP models been discussed with regulators? Select all that apply
  • What type of regulatory communication or submission vehicle included QSP model reporting? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely (
    Rows
  • Under which scenario(s) is QSP not included despite availability? Select all that apply

  • 4. Model Credibility Assessment Frameworks and Activities

  • Which model evaluation activities are routinely performed internally? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely (
    Rows
  • Which model evaluation activities are used for regulatory interactions? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely (
    Rows
  • How familiar are you with the ICH M15 guideline? Select one.
  • How is risk or model influence assessed in determining model evaluation requirements?
    Rows
  • How is risk or model influence assessed in determining model evaluation requirements?
  • Which framework is used to determine model evaluation requirements?

  • 5. Reporting Standards and Documentation Practices

  • How are credibility assessments documented?
  • Which standard has been used in reporting? Select all that apply
  • Do you use version control and archival practices for models and modeling reports intended for regulatory interactions?
  • Have you published QSP models as part of documentation strategy?

  • 6. QSP Content in Regulatory Meeting Packages and Submissions

  • In MIDD meetings, how often are the following QSP proposal elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • In other regulatory meetings, Type A, C, D, PIP, Scientific Advice, Protocol Advice, etc., how often are the following QSP proposal elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • In Phase 1 INDs, how often are the following QSP proposal elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • In Phase 2 INDs, how often are the following QSP proposal elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • In Phase 3 INDs, how often are the following QSP proposal elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • For QSP analyses included in BLA/NDA/MAA or supplements, how often are the following elements included? Frequency scale: Always (>80%), Often (50–80%), Sometimes (20–50%), Rarely(
    Rows
  • If eDATASETs are included for QSP analyses in BLA/NDA submissions, when are they submitted?

  • 7. QSP Summary and Technical Report Content

  • What elements do you typically include in a QSP summary report? Select all that apply.
  • What elements do you typically include in a QSP technical report? Select all that apply.

  • 8. Use of AI in QSP Modeling and Reporting

  • How do you use AI technologies for modeling and reporting activities? Select all that apply.

  • 9. Regulatory Feedback and Agency Expectations

  • Have regulators provided feedback specifically on model credibility documentation?
  • What was the outcome of the regulatory interaction with respect to the QSP evidence?
  • Have agencies expressed preferences regarding how QSP analyses should be documented?
  • Have agencies requested executable code or simulation packages if not provided in submissions?
  • Have you been asked to reformat or restructure QSP documentation following review?
  • Did agencies assess the submitted QSP credibility formally, e.g. explicit feedback/question on QSP model?

  • 10. Internal Stakeholder Alignment and Governance

    Optional to skip for CRO respondents

  • How is QSP positioned internally for regulatory use?
  • Is there existing internal QSP model evaluation SOPs or governance board?
  • What decides whether QSP is included in regulatory interactions? Check all that apply.
  • Rate importance of alignment with the following functions in QSP model usage in regulatory decisions. Rate importance on scale of 1-5, with 1 being the most important.
    Rows
  • Common alignment challenges. Select all that apply.
  • Is there a functional champion advocating for QSP inclusion?

  • 11. Cross-Functional Collaboration in Submissions

  • How are QSP analyses integrated into submission teams?
  • Which functions co-author QSP submissions content?
  • How effective has communication around QSP modeling been in the following areas? Rate on a scale of 1-5 with 1 being the most effective.
    Rows
  • Has inclusion of QSP ever been limited by submission timelines?

  • 12. External Collaboration and Pre-Competitive Alignment

  • Has your organization engaged in external collaborations specifically related to QSP model development, credibility assessment, or regulatory strategy? Select all that apply.
  • What are the key barriers to effective external collaboration for regulatory QSP? Select all that apply.
  • What forms of external collaboration would be most valuable to advance regulatory acceptance of QSP? Select top 3.

  • 13. Gaps, Barriers, and Future Needs

  • Would harmonized guidance specific to QSP credibility be valuable?
  • Should be Empty: