Feedback on Virtual Course Title "IMPACT" Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes (CDRH)

Hello,

Thank you for joining us for the IMPACT Bootcamp today, hosted by Yale-Mayo CERSI and the Food and Drug Administration (FDA). We would really appreciate it if you could complete the following short survey by Friday, 3/12. Your feedback will be used to help improve the course: <survey link>

Please let me know if you have any questions.

Thanks,

Jaci Gosse

Yale-Mayo CERSI

OMB Control No: 0910-0360 Expiration Date: 10/31/2023

Feedback on IMPACT Bootcamp

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0360. The time required to complete this information collection is estimated to average 10 minutes per respondent, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

We invite you to share your feedback regarding the March 9, 2021 IMPACT Bootcamp: Navigation the Journey from Digital Health Technologies to Meaningful Patient Outcomes. We appreciate your candid responses.

Your participation/non-participation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. All respondent identification and information will be anonymous unless otherwise indicated. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept secure to the fullest extent allowed by law.

1. Overall, how would you rate the virtual bootcamp?

   1. 1 – Very Poor

   2. 2 – Poor

   3. 3— Average

   4. 4 – Good

   5. 5 – Excellent

2. How likely are you to recommend the IMPACT Bootcamp to a colleague?

1 (Not at all likely) – 10 (Extremely likely)

3. How would you rate the length of the virtual bootcamp?

   1. Too short

   2. About right

   3. Too long

4. Did you review the pre-bootcamp materials?

   1. Yes, all materials

   2. Yes, some materials

   3. No

5. After attending this event, do you have a greater understanding of at least one aspect of regulatory science (e.g., digital health technologies, patient preference information, clinical outcome assessments)?

   1. Yes

   2. No

6. For each of the below sessions, please evaluate the statement “This session was informative” [Strongly Disagree, Disagree, Neither Agree or Disagree, Agree, Strongly Agree]

   1. Pre-bootcamp videos

   2. Recap and Application of Concepts 1: Digital Health Technologies (DHTs) (Speaker: Bakul Patel)

   3. Recap and Application of Concepts 2: Patient Input and Clinical Outcome Assessments (Speaker: Michelle Tarver)

   4. Hands-On Practice 1: Patient Input to Support Your DHT Development

   5. Hands-On Practice 2: Developing Your DHT to be Used to Support Clinical Investigations

   6. Hands-On Practice 3: Developing Your DHT to be Used Outside of Clinical Investigations (i.e., to Diagnose, Treat, or Promote General Wellness)

7. What is one thing that you learned that you may apply to your work?

8. Please share any other feedback you may have:

9. What topics would you like to see covered in future CERSI-FDA courses?