APPENDIX B INITIAL REVIEW PROCEDURES FORMS

REVISION HISTORY

Rev

No. Review Date Description of Change Date of Next Review

0 Original July 2020

1 December 2020 Change of Format December 2021

Reviewed by:

GILBERT C. VILELA, MD

Deputy Executive Director for Education

Training and Research Services

Approved by:

JOEL M. ABANILLA, MD

Executive Director

Appendix B

Initial Review Procedures Forms

FM-E-IRB-021-2019 Rev. 05

Initial Review Application form FM-E-IRB-014-2019

Rev. 04

Document Receipt Form FM-E-IRB-046-2019

Rev. 08

IERB Reviewer’s Evaluation Form FM-E-IRB-044-2019

Rev. 07

Participants Information and Informed Consent Form FM-E-IRB-041-2019

Rev. 04

Request for Waiver of Informed Consent Form FM-E-IRB-042-2019

Rev. 05

Participant Information and Assent Form (For ages 12 to below 15)

FM-E-IRB-017-2019 Rev. 06

IERB Decision Form FM-E-IRB-056-2019

Rev. 05

Modification Letter Template FM-E-IRB-022-2019

Rev. 05

Resubmission Report Form FM-E-IRB-045-2019

Rev. 08

Decision Letter for Protocol Approval Template FM-E-IRB-087-2019

Rev. 00

Certificate of Exemption from Ethics Review

FM-E-IRB-2019- 021-Rev. 06

Initial Review Application Form

FM-E-IRB-2019-014 Rev. 05

Document Receipt Form

FM-E-IRB-2019-046 Rev. 08 IERB Reviewer’s Evaluation Form

FM-E-IRB-044-2019 Rev. 07

Participants Information and Informed Consent Form

FM-E-IRB-041-2019 Rev. 04

Request for Waiver of Informed Consent Form

FM-E-IRB-042-2019 Rev. 05

Participant Information and Assent Form

(For ages 12 to below 15)

FM-E-IRB-017-2019 Rev. 06

IERB Decision Form

FM-E-IRB-056-2019 Rev. 05

Modification Letter Template

FM-E-IRB-022-2019 Rev. 05

Resubmission Report Form

FM-E-IRB-045-2019 Rev. 08

Decision Letter for Protocol Approval Template

FM-E-IRB-087-2019 Rev. 00

Certificate of Exemption from Ethics Review