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* 1. Do you implement RBA in Investigator-initiated clinical trials or studies in your hospital?

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* 2. Who are the members in your hospital to carry out RBA? (Please select all that apply)

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* 3. Status of RBA introduction: Investigator-Initiated Trials, IITs (for NDA purpose) （Please select 「Others」 if RBA is not introduced to any IIT）

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* 4. Status of RBA introduction: Sponsor-Initiated Trials (for NDA purpose)(Please select 「Others」 if RBA is not introduced to such trials）

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* 5. Status of RBA introduction: Other clinical trials (Eg. IIT for academic/non NDA purpose)(Please select 「Others」 if RBA is not introduced to other clinical trials）

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* 6. As the main hospital where the overall PI is, how many trials have you introduced RBA to (including completed trials)?

Investigator-Initiated Trials, IITs (for NDA purpose).

 If no such trial please fill in 「０」

You could skip this question if no such data available

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* 7. As the main hospital where the overall PI is, how many trials have you introduced RBA to (including completed trials)?

Sponsor-Initiated Trials (for NDA purpose)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 8. As the main hospital where the overall PI is, how many trials have you introduced RBA to (including completed trials)?

Other clinical trials

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 9. How many trials have you conducted Risk-Based Monitoring (RBM) based on the agreed RBA as the main hospital where the overall PI is? (including completed trials)

Investigator-Initiated Trials, IITs (for NDA purpose)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 10. How many trials have you conducted Risk-Based Monitoring (RBM) based on the agreed RBA as the main hospital where the overall PI is? (including completed trials)

Sponsor-Initiated Trials (for NDA purpose)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 11. How many trials have you conducted Risk-Based Monitoring (RBM) based on the agreed RBA as the main hospital where the overall PI is? (including completed trials)

Other clinical trials

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 12. How many of the trials RBA was introduced have been audited in your hospital? (including outsourced to Clinical Research Organization, CRO)

Investigator-Initiated Trials, IITs (as the main hospital where the overall PI is)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 13. How many of the trials RBA was introduced have been audited in your hospital?  (including outsourced to Clinical Research Organization, CRO)

Investigator-Initiated Trials, IITs (as branch hospital or participating hospital)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 14. How many of the trials RBA was introduced have been audited in your hospital?  (including outsourced to Clinical Research Organization, CRO)

Sponsor-Initiated Trials (for NDA purpose)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 15. How many of the trials RBA was introduced have been audited in your hospital? (including outsourced to Clinical Research Organization, CRO)

Other clinical trials (Eg. IIT for academic/non NDA purpose)

If no such trial please fill in 「０」

You could skip this question if no such data available

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* 16. Is any education or training session arranged before RBA is introduced?

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* 17. Who conducts RBA training? (Please select all that apply)

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* 18. Who are the trainees of the RBA education?
(Please select all that apply)

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* 19. Please address the frequency and timing of RBA education
(For example: 1 training for researchers is performed before trial initiation)

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* 20. The readiness of SOPs and manuals in order to implement RBA

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* 21. Documents prepared for RBA implementation
(Such as Glossary, Risk evaluation form)

(Select all that apply)

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* 22. Is it possible to share the above documents with the Japan ARO secretariat (Chiba University)?
(These files are only for documentation in the secretariat and will not be shared)

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* 23. The readiness of audit policy/guidelines, audit manuals (samples/templates) etc for RBA

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* 24. Documents already prepared.

(Please select all that apply)

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* 25. From which stage of the trial do you identify important data processes?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply）

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* 26. When does risk identification begin?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply）

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* 27. Which criteria do you assess the risk you identify?

(Please select all that apply ）

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* 28. Do you use something like risk evaluation form to assess risks?

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* 29. If you answer “No” in Q.28, please share the reason with us.

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* 30. Any tools you use/refer for risk evaluation

(Please select all that apply)

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* 31. Do you specify mitigation actions for each risk identified?

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* 32. Do you set any risk indicators or risk thresholds that lead to direct review prior to the trial initiation?

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* 33. Do you have any criteria/standards for setting those risk indicators and thresholds?

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* 34. Do you prepare an integrated quality risk management plan etc for each trial so that the quality control activities of each department function properly?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply)

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* 35. Do you regularly conduct risk reviews after setting the frequency and criteria in advance?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply)

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* 36. Please address review frequency and criteria/standards in your hospital

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* 37. Number of trials implemented with central monitoring (for trials supported by Clinical Trial Center, or Clinical Trial Center serves as CRO)

If no such trial please fill in 「０」

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* 38. If you have central monitoring, do you utilize their results for on-site and off-site monitoring?

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* 39. If you change monitoring methods (on-site, off-site monitoring, central monitoring) for each trial, do you have any criteria for the selection?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Select all that apply)

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* 40. Who creates a monitoring plan when RBM is introduced based on RBA?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply)

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* 41. Do you create a template for the monitoring plan for each study type (Investigator-initiated clinical trial, sponsored clinical trial, other clinical trials)?

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* 42. After the trial starts, do you modify the monitoring plan according to the risk identified?

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* 43. Do the entire project team members (researchers, research supporters) understand “Quality Tolerance Limit” and set it properly?

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* 44. Is the Quality Tolerance Limit set before the trial initiation?

(If the situation differs from trial to trial, please separately address the situation in Others after answering the representative one.)

(Please select all that apply)

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* 45. Are any criteria/ standards of the Quality Tolerance Limit available?

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* 46. Is there an RBA manual for researcher education?

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* 47. Is there an RBA manual for research supporter education?

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* 48. What are the challenges for implementing RBA?

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* 49. Name of the hospital

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* 50. Your Full Name

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* 51. Your Email Address (for future contact)

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