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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
APPROVAL_SEQUENCE_NO
PROP_NO

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


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.

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