PENNERA_PROP_REGULATORY_APPR Table
DWADMIN Schema
Explanation
For sponsored projects that involve human subjects, laboratory animals, or
hazardous materials, or that have other aspects that are subject to regulatory
oversight, the PENNERA_PROP_REGULATORY_APPR table stores information on each
regulatory approval.
There is one PENNERA_PROP_REGULATORY_APPR record
per proposal per protocol (or other aspect of the proposal that is subject
to regulatory oversight).
Common Uses
- Listing proposals that require a particular kind of regulatory approval.
("How many of Dr. Doe's proposals require radiation safety approval?")
- Reporting protocol ID numbers for proposals that have been linked to human
subject or laboratory animal protocols.
Primary Key |
Indexed Data Elements |
Related Tables |
PROP_NO
APPROVAL_SEQUENCE_NO
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APPROVAL_SEQUENCE_NO
PROP_NO
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PENNERA_INCREMENT
PENNERA_PERIOD
PENNERA_PERIOD_STAT_HIST
PENNERA_PROP_STAT_HIST
PENNERA_PROPOSAL
PENNERA_PROPOSAL_ACTIVITY
PENNERA_PROPOSAL_INVESTIGATOR
PENNERA_PROPOSAL_PARENT
PENNERA_REQUEST
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Cautions
- The PENNERA_PROP_REGULATORY_APPR table stores information only on proposals
that have one or more aspects that are subject to regulatory oversight. If
a proposal does not require any regulatory approvals, there are no records
for the proposal in the PENNERA_PROP_REGULATORY_APPR
table.
- The PENNERA_PROP_REGULATORY_APPR table stores information on a variety
of regulatory approvals. The table reflects both what is
shown on
the Approvals screen in PennERA's Proposal Tracking module and (for all
protocols that are linked to proposals in
the PennERA system) what
is
shown
on the Summary screen in the relevant PennERA protocol tracking module.
- Besides approvals for
protocols involving human subjects or laboratory animals, the
table tracks approvals for
- biosafety
- carcinogens, teratogens, or mutagens
- clinical trials
- hazardous materials
- in vitro formation of recombinant DNA
- infectious agents
- radiation
safety
- select
agents (biological agents or toxins deemed by the federal
government to be a threat to the public, animal or plant health,
or to animal
or plant
products)
- The REGULATORY_TYPE describes the area of the proposal
that is subject to regulatory oversight, or names the administrative
group
responsible for approving the protocol
(or other aspect
of
the proposal
that is
subject to regulatory oversight). The values for REGULATORY_TYPE have changed
over time. For more information, see the data element documentation for
REGULATORY_TYPE.
- There is one PENNERA_PROP_REGULATORY_APPR record per proposal, per protocol
(or other aspect of the proposal that is subject to regulatory oversight).
- The PENNERA_PROP_REGULATORY_APPR table
is set up to store one record per proposal (INSTITUTION_NO or PROP_NO),
per APPROVAL_SEQUENCE_NO. At present, no two records have the
same value for the APPROVAL_SEQUENCE_NO.
- The protocol (or other aspect of the proposal that is subject to regulatory
oversight) is identified by the REGULATORY_TYPE and the REFERENCE_NO.
- If the REGULATORY_TYPE is not ‘Human Subjects’ or ‘Lab
Animals’, the proposal has, at most, one record per REGULATORY_TYPE.
- If the REGULATORY_TYPE is ‘Human Subjects’ or ‘Lab
Animals’, and the REFERENCE_NO is not null, the proposal has
one record per REGULATORY_TYPE per REFERENCE_NO. Note: a given ‘Human
Subjects’ or ‘Lab Animals’ protocol may be associated
with more than one proposal.
- In some instances,
the proposal has one or more ‘Human Subjects’ or ‘Lab
Animals’ records where the REFERENCE_NO is null. This is the
case when it is known that the proposal will involve one or more
such protocols, but the protocols' Institution Nos. (REFERENCE_NOs)
are unknown.
- There are two different unique identifiers for a proposal (funding
cycle) in PennERA: INSTITUTION_NO and PROP_NO. INSTITUTION_NO is the identification
number assigned by the University. PROP_NO is the identification number used
internally by the PennERA system. For a given record, INSTITUTION_NO will not have
the same value as PROP_NO. While either one may be used when joining PennERA
Proposals tables, INSTITUTION_NO is the one recommended for display in reports.
- Records with an INSTITUTION_NO less than or equal to 05017400 were converted
from the Research Services System (RSS, the system used to track proposals
and awards before October 14, 2003). Other records are for proposals created
in PennERA.
- There are two different identifiers for a protocol in the PENNERA_PROP_REGULATORY_APPR
table: REFERENCE_NO and PROT_NO.
REFERENCE_NO is the one recommended for display
in reports.
- REFERENCE_NO is the code used by the relevant
regulatory office to identify the protocol (or
other aspect of the proposal that is subject to regulatory oversight).
PROT_NO is the protocol identification number
used
internally by the relevant PennERA protocol tracking module (Human Subjects
or Animal Use). For a given record, REFERENCE_NO will not have
the same value as PROT_NO.
- Neither REFERENCE_NO nor PROT_NO uniquely identifies a protocol or
activity within the PENNERA_PROP_REGULATORY_APPR
table.
- For example, no two Human Subjects (HS) protocols have the same
REFERENCE_NO, and no two Lab Animals (LA) protocols have the same
REFERENCE_NO, but the REFERENCE_NO
for an HS protocol could also be used for an LA protocol or for another
protocol.
- PROT_NO is used only for HS and LA protocols. Although no two HS
protocols have the same PROT_NO, and no two LA protocols have the
same PROT_NO, the PROT_NO for an HS protocol could also be used for
an LA protocol.
- The value for REFERENCE_NO may contain letters, numerals,
and other characters, or it may be null.
- If the REGULATORY_TYPE is 'Human Subjects' (HS) or 'Lab Animals'
(LA) and the PROT_NO is not null, REFERENCE_NO
is the 6-digit Institution No. assigned to the protocol by the University
and used to identify the protocol in the relevant PennERA protocol
tracking module. The REFERENCE_NO for an HS or LA protocol uses only
numerals, and includes leading zeroes. Note: a given ‘Human Subjects’ or ‘Lab
Animals’ protocol may be associated with more than one proposal.
- Some proposals converted from RSS involve regulatory approvals.
However, the protocol ID's were not converted, because they were
not used consistently in RSS. Data
may have been entered for the REFERENCE_NO in some of the converted
records since PennERA
was
implemented
(October 14, 2003). However, records for proposals that have been inactive
since then probably have a null value for REFERENCE_NO.
- The value for PROT_NO is 10 digits, and includes leading zeroes. However,
PROT_NO is null if
- the REGULATORY_TYPE is not 'Human Subjects' or 'Lab Animals', or
- the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' but the
REFERENCE_NO is not found as the Institution No. for a protocol in
the relevant PennERA protocol tracking module.
- The combination of PROTOCOL_ATTACHED and PROT_NO indicates
whether or not the proposal has been linked to the protocol in the PennERA
system.
‘Human Subjects’ and ‘Lab Animals’ are
the only REGULATORY_TYPEs whose protocols can be linked to the proposal in
the PennERA system. The protocol is linked to the proposal if PROTOCOL_ATTACHED
is 'Attached' and PROT_NO is not null. The value for PROTOCOL_ATTACHED
ought to be ‘Not Attached’ or null for other REGULATORY_TYPEs.
- The PENNERA_PROP_REGULATORY_APPR
table stores the following approval details for the protocol (or other
aspect of the proposal that is subject to regulatory oversight): APPROVAL_DATE,
APPROVAL_STATUS, APPROVED_FROM, APPROVED_TO, and REVIEW_CATEGORY. If
the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the PROT_NO
is not null, this detailed information reflects what is shown on the Summary
screen in PennERA's Human Subjects or Animal Use protocol tracking module.
Otherwise, the
information reflects what is shown on the Approvals screen in PennERA's
Proposal Tracking module, where the approval details might not be kept
up-to-date.
Source
The PennERA tracking modules for Proposals,
Human Subjects protocols, and Animal Use protocols. PennERA has been
used at Penn since October 14,
2003
to track information on proposed and awarded grants and contracts.
PennERA is the University's electronic research administration system, providing
support to faculty and research administrators for all sponsored project activity
at the University of Pennsylvania.
Questions about this page? Email us at da-staff@isc.upenn.edu
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