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University of Pennsylvania  Institutional Review Board
Appendix A-1: [Completeness Prereview] Check Drugs, Biologics, Devices
PI:
Protocol #
Drugs & Biologics
Drug # 1: Name:
N/A
(choose one, a-d, below)
(a)
Drug is marketed / FDA-approved & will be used as marketed/approved 
If no, complete this section of the form.
Package Insert submitted
(b)
Drug is investigational  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  e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted  e-mail PI to request IB
(c)
IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d)
IND exemption documentation not attached  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 
If no, complete this section of the form.
Package Insert submitted
(b)
Drug is investigational  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  e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted  e-mail PI to request IB
(c)
IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d)
IND exemption documentation not attached  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 
If no, complete this section of the form.
Package Insert submitted
(b)
Drug is investigational  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  e-mail PI to request receipt of documentation
Investigator’s brochure (IB) submitted
Investigator’s brochure (IB) not submitted  e-mail PI to request IB
(c)
IND exemption documentation attached (FDA, OHR, or Cancer Center)
(d)
IND exemption documentation not attached  e-mail PI to request receipt of documentation
Devices
Device # 1: Name:
(a)
(choose one, a-e, below)
Sponsor categorizes investigational device as significant risk (SR)
Page 1 of 2
N/A
IDE #
documentation
attached
Appendix A1: [Completeness] Drugs, Biologics, Devices

Operations manual /
FDA labeling submitted.
Version: 26 July 2009
University of Pennsylvania  Institutional Review Board
Appendix A-1: [Completeness Prereview] Check Drugs, Biologics, Devices
(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
(e)
Other:
Device # 2: Name:
(choose one, a-e, below)
(a)
Sponsor categorizes investigational device as significant risk (SR)
(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
(e)
Other:
Page 2 of 2
510(k) #
documentaton
attached
IDE #
documentation
attached

Operations manual /
FDA labeling submitted.
510(k) #
documentation
attached
Appendix A1: [Completeness] Drugs, Biologics, Devices
Version: 26 July 2009