As a member of an Expert Advisory Panel to the FDA, I will use the data collected to provide the panel with a comprehensive view of the barriers to adopt and implement Risk Based Monitoring (RBM), eSource, and ICH E6(R2).

Thank you for participating in this survey.  The results provided will be anonymous.  If you would like to receive the results, please provide your contact information at the end of the survey. If you have questions, please contact me at pmanasco@manarbm.com or 919-556-9456.
- Penelope Manasco, M.D.

* 1. Please choose the Type of Organization.

* 2. Please choose the role that best describes your Organizational Responsibilities

* 3. Have you implemented RBM for your trials?

* 4. Who makes the decision to implement RBM?

* 5. If you have not implemented RBM or only implement RBM on a minority of studies, what are the barriers for adoption? Select all that apply.

* 6. What % of your studies implement RBM?

* 7. If you have implemented RBM, are you using strictly RBM or RBM and a hybrid approach?

* 8. In your studies that use RBM, what monitoring approaches are used? Select all that apply.

* 9. In your trials that have implemented RBM, what has been your outcome to date? Select all that apply.

* 10. If your organization has implemented RBM or you have participated in RBM studies, what were your challenges to implementing RBM?

* 11. Have you implemented electronic Source or Direct Data Entry from EDC as discussed in the FDA eSource Guidance?

* 12. If no, please provide the reason(s)

* 13. Have you implemented electronic Trial Master Files?

* 14. Have you implemented electronic Investigator Site Files?

* 15. If no, please provide the reason(s)

* 16. Have you implemented electronic Informed Consent?

* 17. If no, please provide the reason(s)

* 18. Have you implemented new CRO oversight approaches?

* 19. If no, please provide the reason(s)

* 20. Have you implemented new approaches to quality management since release of ICHE6(R2)?

* 21. If no, please provide the reason(s)

* 22. What could Regulators do to help implement the guidance on RBM and eSource and ICHE6(R2)?

* 23. What can Industry do to help implement the guidance on RBM, eSource, and ICHE6(R2)?

* 24. Please provide any additional comments

* 25. The results of this survey will be used to provide feedback on RBM Barriers to Adoption. If you would like a copy of the results, please provide your name and contact information.

* 26. Would you be willing to be contacted to provide additional input of RBM Adoption?

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