University of Pennsylvania w Institutional Review Board

Appendix A-1: [Completeness Prereview] Check Drugs, Biologics, Devices

PI: Protocol #

Drugs & Biologics N/A
Drug # 1: Name: (choose one, a-d, below)
(a) Drug is marketed / FDA-approved & will be used as marketed/approved è Package Insert submitted
If no, complete this section of the form.
(b) Drug is investigational è IND # IND holder
Documentation of IND attached The IND number must either match the number on the sponsor protocol with the same title as the proposed research, or be listed on communication from the sponsor specific to the proposed research, or on communication with the FDA.
Documentation of IND not attached è e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted è e-mail PI to request IB
(c) IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d) IND exemption documentation not attached è e-mail PI to request receipt of documentation
Drug # 2: Name: (choose one, a-d, below)
(a) Drug is marketed / FDA-approved & will be used as marketed/approved è Package Insert submitted
If no, complete this section of the form.
(b) Drug is investigational è IND # IND holder
Documentation of IND attached The IND number must either match the number on the sponsor protocol with the same title as the proposed research, or be listed on communication from the sponsor specific to the proposed research, or on communication with the FDA.
Documentation of IND not attached è e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted è e-mail PI to request IB
(c) IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d) IND exemption documentation not attached è e-mail PI to request receipt of documentation
Drug # 3: Name: (choose one, a-d, below)
(a) Drug is marketed / FDA-approved & will be used as marketed/approved è Package Insert submitted
If no, complete this section of the form.
(b) Drug is investigational è IND # IND holder
Documentation of IND attached The IND number must either match the number on the sponsor protocol with the same title as the proposed research, or be listed on communication from the sponsor specific to the proposed research, or on communication with the FDA.
Documentation of IND not attached è e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted è e-mail PI to request IB
(c) IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d) IND exemption documentation not attached è e-mail PI to request receipt of documentation
Devices N/A
Device # 1: Name: (choose one, a-e, below)
(a) Sponsor categorizes investigational device as significant risk (SR) / IDE #
documentation attached / è / Operations manual / FDA labeling submitted.
(b) Sponsor categorizes investigational device as non-significant risk (NSR)
(c) Device is marketed / FDA-approved & will be used as marketed/approved
(d) 510(k) is marketed / FDA-approved & will be used as marketed/approved / 510(k) #
documentaton attached
(e) Other:
Device # 2: Name: (choose one, a-e, below)
(a) Sponsor categorizes investigational device as significant risk (SR) / IDE #
documentation attached / è / Operations manual / FDA labeling submitted.
(b) Sponsor categorizes investigational device as non-significant risk (NSR)
(c) Device is marketed / FDA-approved & will be used as marketed/approved
(d) 510(k) is marketed / FDA-approved & will be used as marketed/approved / 510(k) #
documentation attached
(e) Other:

Page 2 of 2 Appendix A1: [Completeness] Drugs, Biologics, Devices Version: 26 July 2009