List of Appendices (original submission and resubmission to complete study)

FDA Generic List of Appendices for OMB 2.18.22.docx

Data to Support Drug Product Communications

List of Appendices (original submission and resubmission to complete study)

OMB: 0910-0695

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Appendix Name

Status

Appendix A: Youth Generic Screener (DPI)

Not included in 2022 resubmission

Appendix B: Youth Generic Screener (AI)

After being updated for virtual data collection, it is now Appendix N

Appendix C: Adult Screener (DPI)

Not included in 2022 resubmission

Append D: Adult Screener (AI)

After being updated for virtual data collection, it is now Appendix O

Appendix E: Adult Consent Form

After being updated for virtual data collection, it is now Appendix Q

Appendix F: Youth Assent Form

After being updated for virtual data collection, it is now Appendix R

Appendix G: Parental Permission Form

After being updated for virtual data collection, it is now Appendix S

Appendix H: Worksheet and workbook

The pre-group worksheet was not included in 2022 submission as it will not be used in the virtual focus groups. The workbook changed only slightly as we removed Exercise 1 but kept Exercise 2 (the journey mapping exercise) as is. We realized we needed to update the workbook and submit the change to IRB. After being updated for virtual data collection, the workbook is now Appendix X. This was missed in the last submission and a new amendment will be made today to include it and we have attached it for your records along with the updated protocol that mentions it.

Appendix I: Moderator Guide

After being updated for virtual data collection, it is now Appendix T

Appendix J: Recruitment Confirmation and Reminder Emails

After being updated for virtual data collection, it is now Appendix U

Appendix K: Sample Recruitment Media Advertisement Language

After being updated for virtual data collection, it is now Appendix M

Appendix L: Programmed pre-screener

After being updated for virtual data collection, it is now Appendix P

Appendix M: Sample Recruitment Media Advertisement Language_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix N: Adolescent Screener EpiPens_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix O: Adult Autoinjector Screener_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix P: Programmed pre-screener_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix Q: Adult Consent Form_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix R: Youth Assent Form_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix S: Parental_Permission Form_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix T: Moderator Guide_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix U: Recruitment Confirmation and Reminder Emails_virtual revisions

Updated for virtual data collection; included in 2022 resubmission

Appendix V: Advance Letter_virtual groups

New; included in 2022 submission

Appendix W: Mailed Instructions_virtual groups

New; included in 2022 submission

Appendix X: Workbook_virtual revisions

Updated for virtual data collection; included in 2022 submission



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorDavis, Christine
File Modified0000-00-00
File Created2022-07-01

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