PENNERA_PROP_REGULATORY_APPR Table - Data Element Index
Select a data element to view its definition and its indexed, format, and
null values.
Data element |
Definition |
APPROVAL_DATE
Indexed - no
Format - date
May be null? yes |
If known, this is the date approval was granted for the protocol (or
other aspect of the proposal that is subject to regulatory oversight)
that is identified by
the REGULATORY_TYPE and the REFERENCE_NO. The value may be null.
If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the
PROT_NO is not null, APPROVAL_DATE reflects what is shown
on the Summary screen in the relevant PennERA 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.
Example: 11/15/2003
Values:
List of values not available.
PennERA source: If the REGULATORY_TYPE is 'Human Subjects'
or 'Lab Animals' and the PROT_NO is not null, the Human Subjects or Animal
Use protocol tracking
module;
Summary screen; Summary section; Approval box; Date. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; the Approved column
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO. |
APPROVAL_SEQUENCE_NO
Indexed - yes
Format - number (27)
May be null? no |
A number that uniquely identifies the protocol (or
other aspect of the proposal that is subject to regulatory oversight),
within the proposal to which it applies. The PENNERA_PROP_REGULATORY_APPR
table is set up to store one record per proposal (INSTITUTION_NO
or PROP_NO), per APPROVAL_SEQUENCE_NO. However, at present, no two records
have the same value for the APPROVAL_SEQUENCE_NO.
Examples: 0, 1672222
Values:
List of values not available. |
APPROVAL_STATUS
Indexed - no
Format - varchar2 (22)
May be null? yes |
If known, this indicates the status of the approval for the protocol
(or other aspect of the proposal that is subject to regulatory oversight)
that is identified
by
the
REGULATORY_TYPE and the REFERENCE_NO. The value may be null.
If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the
PROT_NO is not null, APPROVAL_STATUS reflects what is shown on the Summary
screen in the relevant PennERA 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.
Values:
Acknowledged
Acknowledged (CHOP/Pen
Administrative Ina
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Administrative Inactiv
Approved
Approved (CHOP/Penn)
Approved Status Wi
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Approved Status Withhe
Completed
Conditional Re-app
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Conditional Re-approva
Conditionally Appr
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Conditionally approved
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Disapproved
Expired
Issue Identified
Logged
New Protocol
Pending
Tabled
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Terminated
Unknown
Withdrawn Submissi
(used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR)
Withdrawn Submission
Withheld Approval
[null]
PennERA source: If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals'
and the PROT_NO is not null, the Human Subjects or Animal Use protocol
tracking
module;
Summary screen; Summary section; Approval box; Status. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; the Status column
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO. |
APPROVED_FROM
Indexed - no
Format - date
May be null? yes |
If known, this indicates the date of the beginning of the period for
which approval has been granted for the protocol (or
other aspect of the proposal that is subject to regulatory oversight)
that is identified
by
the REGULATORY_TYPE and the REFERENCE_NO. The value may be null.
If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the
PROT_NO is not null, APPROVED_FROM reflects what is shown on the Summary
screen in the relevant PennERA 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.
Example: 01/01/2004
Values:
List of values not available.
PennERA source: If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals'
and the PROT_NO is not null, the Human Subjects or Animal Use protocol tracking
module;
Summary screen; Summary section; Approval box; Approved From. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; click on the View icon
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO; Approved From. |
APPROVED_TO
Indexed - no
Format - date
May be null? yes |
If known, this indicates the date of the end of the period for
which approval has been granted for the protocol (or
other aspect of the proposal that is subject to regulatory oversight)
that is identified by the REGULATORY_TYPE and the REFERENCE_NO. The
value may be null.
If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the
PROT_NO is not null, APPROVED_FROM reflects what is shown on the Summary
screen in the relevant PennERA 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.
Example: 12/31/2004
Values:
List of values not available.
PennERA source: If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals'
and the PROT_NO is not null, the Human Subjects or Animal Use protocol
tracking module; Summary screen; Summary section; Approval box; Approved
To. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; click on the View icon
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO; Approved To. |
INSTITUTION_NO
Indexed - no
Format - char (8)
May be null? yes |
The eight-digit sequence number used by the University to uniquely identify
the PennERA proposal for the project period (funding cycle) that has
an aspect that is subject to regulatory oversight.
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 unique identifiers for a proposal: INSTITUTION_NO
and PROP_NO. INSTITUTION_NO is used by the University. PROP_NO is 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.
There is one PENNERA_PROP_REGULATORY_APPR record per proposal (INSTITUTION_NO
or PROP_NO), per APPROVAL_SEQUENCE_NO.
Example: '04076500'
Values:
Refer to the PENNERA_PROP_REGULATORY_APPR
Table for values.
PennERA source: For HS and LA protocols that were linked to the proposal
via
the protocol tracking module, the Human Subjects or Animal Use protocol
tracking module; the Summary / Linked Components screen; the Number column in
the row for the
proposal. For other PENNERA_PROP_REGULATORY_APPR
records, the Proposal Tracking module; Approvals screen; the Proposal
box
in
the
upper right corner of the screen |
LAST_EXTRACT_DATE
Indexed - no
Format - date
May be null? yes |
The date this proposal regulatory approval record was extracted
from the PennERA system and loaded into the Warehouse.
Example: 10/28/2003
Values:
List of values not available. |
PROP_NO
Indexed - yes
Format - varchar2 (20)
May be null? no |
The 10-digit number used internally by the PennERA system to
uniquely identify the proposal for the project period (funding cycle)
that has an aspect that is subject to regulatory oversight.
Note that the value for PROP_NO includes leading zeroes.
There are two different unique identifiers for a proposal: INSTITUTION_NO
and PROP_NO. INSTITUTION_NO is used by the University. PROP_NO is 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.
There is one PENNERA_PROP_REGULATORY_APPR record per proposal (INSTITUTION_NO
or PROP_NO), per APPROVAL_SEQUENCE_NO
Example: ‘0000033499’
Values:
List of values not available.
PennERA source: For HS and LA protocols that were linked to the proposal
via
the protocol tracking module, the Human Subjects or Animal Use protocol
tracking module; the Summary / Linked Components screen; the prop_no for the
proposal (the Number
column in
the row for the
proposal shows the proposal's Institution No.; prop_no is not shown). For
other PENNERA_PROP_REGULATORY_APPR
records, the Proposal Tracking module; Approvals screen; the Proposal box
in
the
upper right corner of the screen; the prop_no for the proposal (the Proposal
box shows the proposal's Institution No.; prop_no is not shown)
|
PROT_NO
Indexed - no
Format - varchar2 (20)
May be null? yes |
The 10-digit number used internally by
the PennERA system to identify the Human Subjects (HS) or Lab Animals
(LA) protocol that is denoted by
the
REGULATORY_TYPE and the REFERENCE_NO. Note that
the value for PROT_NO includes leading zeroes.
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.
PROT_NO does not uniquely identify an HS or LA protocol within
the PENNERA_PROP_REGULATORY_APPR
table. No two HS protocols have the same PROT_NO,
and no two LA protocols have the same PROT_NO, but the PROT_NO
for an HS protocol could also be used for an LA protocol.
There are two different identifiers for an HS or LA protocol in the
PENNERA_PROP_REGULATORY_APPR table: REFERENCE_NO and PROT_NO. 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. PROT_NO is the identification number used internally by the
PennERA system.
For a given record, REFERENCE_NO will not have the same value
as PROT_NO. REFERENCE_NO is the data element recommended for display
in reports.
Example: ‘0000352900’
Values: List of values not available.
PennERA source: the Human Subjects or Animal Use protocol tracking
module;
Summary screen; the prot_no for the protocol whose 6-digit Institution No. is
shown on the first line of the header section at the top of the screen
(the 6-digit
Institution No. is the University's identifier for the protocol; prot_no
is not shown) |
PROTOCOL_ATTACHED
Indexed - no
Format - varchar2 (12)
May be null? yes |
In combination with PROT_NO, this indicates
whether or not the proposal has been linked to the protocol in the PennERA
system. The proposal is identified by the INSTITUTION_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.
‘Human Subjects’ (HS) and ‘Lab Animals’ (LA)
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.
Some sponsors require that, if the proposal involves any protocols,
those protocols must be approved before the proposal is submitted. Other
sponsors have a Just In Time policy—proposals submitted to those
sponsors must have their protocols approved before funding
is awarded. In PennERA, the approved HS and LA protocols for a proposal
also ought to be linked to the proposal before it is
awarded.
Values:
Attached
the proposal has been linked in the PennERA
system to the protocol that is identified by
the REGULATORY_TYPE and the REFERENCE_NO (Note: this value is valid only for HS and LA protocols, and only if PROT_NO is not null.)
Future
the protocol that is identified by the
REGULATORY_TYPE and the REFERENCE_NO has not been linked to the proposal in the PennERA system, but is expected to be linked to it at some future date. (Note: this value is valid only for HS and LA protocols, and ought to be used only in the annual snapshot table, SPFY_PENNERA_PROP_REG_APPR.)
Not Attached
the proposal has not been linked in the
PennERA system to the protocol (or other
aspect of the proposal that is subject to
regulatory oversight) that is identified
by the REGULATORY_TYPE and the
REFERENCE_NO [null]
the protocol (or other aspect of the proposal that is subject to regulatory oversight) is not an HS or LA protocol, or it is not known whether or not the proposal has been linked in the PennERA system to the protocol that is identified by the REGULATORY_TYPE and the REFERENCE_NO
PennERA source: For HS and LA protocols that were linked to
the proposal via the protocol tracking module, the Human Subjects or Animal
Use protocol tracking module; the Summary / Linked Components screen; if
the proposal is listed, it is 'Attached'. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; click on the View icon
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO; the value for the selected Protocol radio button. |
REFERENCE_NO
Indexed - yes
Format - varchar2 (60)
May be null? no |
A character string, whose value 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). If it is not null, the value
for REFERENCE_NO may contain letters, numerals, and other characters.
REFERENCE_NO does not uniquely identify 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.
If the REGULATORY_TYPE is 'Human Subjects' or
'Lab Animals' 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. Note: (1)
the REFERENCE_NO
for
an HS or LA protocol uses only numerals, and includes leading zeroes;
(2) a given HS or LA protocol
may be associated with more than one proposal.
The PROT_NO is
the protocol identification number
used
internally by PennERA. For a given record, REFERENCE_NO will not have
the same value as PROT_NO. REFERENCE_NO is the data element recommended
for display in reports.
Examples: ‘702802’, '08-284', 'V016 37-0018-07'
Values: List of values not available.
PennERA source: For HS and LA protocols that were linked to the proposal
via
the protocol tracking module, the Human Subjects or Animal Use protocol
tracking module; the Summary screen; Summary section; Institution Number. For
other PENNERA_PROP_REGULATORY_APPR
records, the Proposal Tracking module; Approvals screen; Reference column |
REGULATORY_TYPE
Indexed - no
Format - varchar2 (39)
May be null? yes |
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).
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.
Values:
Biosafety Committee
used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR
Carcinogens, teratogens or mutagens
CL APPROVAL
clinical trial; used only in the annual
snapshot table, SPFY_PENNERA_PROP_REG_APPR
Clinical Trial
Environmental Health & Radiation Safety
used only in the annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR
Hazardous Materials
Human Subjects
In vitro formation of recombinant DNA
Lab Animals
Potentially Infectious Agents
Radiation Safety
rDNA
recombinant DNA; used only in the
annual snapshot table,
SPFY_PENNERA_PROP_REG_APPR
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
PennERA source: For HS and LA protocols that were linked to the proposal
via
the protocol tracking module, 'Human Subjects' (for records exported from
the
Human
Subjects
protocol tracking module) or
'Lab Animals' (for records exported from
the
Animal
Use protocol tracking module). For
other PENNERA_PROP_REGULATORY_APPR
records, the Proposal Tracking module; Approvals screen; Type column |
REVIEW_CATEGORY
Indexed - no
Format - varchar2 (18)
May be null? yes |
This indicates the type of review conducted by the University
office that monitors compliance in matters involving the protocol (or
other aspect of the proposal that is subject to regulatory oversight)
that is identified by
the REGULATORY_TYPE and the REFERENCE_NO.
The value of REVIEW_CATEGORY may be null.
If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals' and the
PROT_NO is not null, the REVIEW_CATEGORY reflects what is shown on the
Summary screen in the relevant PennERA 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.
Values:
Administrative
used for activities that do not require
board review, but do require administrative
acknowledgement--for example, the use of publicly
available data with no information that could
be used to identify an individual person
Designated (IACUC)
valid for 'Lab Animals' [LA] protocols only
Exempt
valid for 'Human Subjects' [HS] protocols
only; used for protocols involving non-invasive,
minimal-risk procedures
Expedited
valid for HS protocols only; used for
protocols with minor modifications or amendments
Full
reviewed at a full board meeting of the IRB
(Institutional Review Board, for HS protocols)
or the IACUC (Institutional Animal Care and
Use Committee, for LA protocols)
[null]
the review category is unknown
PennERA source: If the REGULATORY_TYPE is 'Human Subjects' or 'Lab Animals'
and the PROT_NO is not null, the Human Subjects or Animal Use protocol
tracking module; Summary screen; Summary section; Review Category. For other PENNERA_PROP_REGULATORY_APPR
records, Proposal Tracking module; Approvals screen; the Review column
in
the
row
for
the
REGULATORY_TYPE
and REFERENCE_NO. |
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