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HS_PROTOCOL_IRB_V Table

DWSP Schema

Explanation
Actually a view of the HS_PROTOCOL_IRB table (also in the DWSP schema), HS_PROTOCOL_IRB_V has information on all human subjects protocols that have records in the HS-ERA application. HS_PROTOCOL_IRB_V provides a subset of the data that is used by the Institutional Review Board (IRB), including the protocol's title, Principal Investigator (PI), responsible org., Business Administrator (BA), approval status, sponsors, and information on subject compensation.

There is one HS_PROTOCOL_IRB_V record per protocol.

Common Uses

  • Retrieving records for all Human Subjects protocols, regardless of whether they have any proposals listed in the PENNERA_PROP_REGULATORY_APPR table. ("What human subjects protocols have Dr. Smith as the PI?")
  • Enhancing a report that uses the PENNERA_PROP_REGULATORY_APPR table. ("List the regulatory approvals for proposal 12345678, and include the short title for those that are human subjects protocols."
  • Identifying Human Subjects protocols that are not linked (attached) to any proposals in PennERA.
Primary Key Indexed Data Elements Related Tables (and their Schemas)
PROTOCOL_NUMBER
PI_PENN_ID
PROTOCOL_NUMBER
RESPONSIBLE_ORG
DATA_PROTECTION (DWSP)
EMPLOYEE_GENERAL (DWADMIN)
HS_PROTOCOL_CTRC (DWSP)
HS_PROTOCOL_IRB (DWSP)
HS_PROTOCOL_LOV (DWSP)
IRB_PROTOCOL_PROPOSAL (DWSP)
KEY_STUDY_PERSONNEL (DWSP)
ORG_CODES (DWADMIN)
PENNERA_PEOPLE (DWADMIN)
PENNERA_PROP_REGULATORY_APPR (DWADMIN)
PENNERA_SPONSORS (DWADMIN)
PROTOCOL_INTERVENTIONS (DWSP)
STUDY_MONITORING (DWSP)
STUDY_SITES (DWSP)
VULNERABLE_POPULATIONS (DWSP)


Cautions

  • HS_PROTOCOL_IRB_V was developed to enable users of the PennERA Proposals data collection to get basic information on human subjects protocols. Although the list of related tables shown above includes many that may be joined to HS_PROTOCOL_IRB_V, the view is intended to be used only with HS_PROTOCOL_LOV and the PENNERA_ tables.
    • Business Objects users that wish to use the HS_PROTOCOL_IRB_V data for the human subjects protocols in the PENNERA_PROP_REGULATORY_APPR table will find that data in HS Protocol IRB V - APPR (a sub-folder of the folder called Pennera Prop Regulatory Appr) in the PennERA Proposals and PennERA Balances Universes.
  • Users with access to the PennERA Proposals data collection automatically have access to HS_PROTOCOL_IRB_V. Users with University-wide access may see all may see all of the records in HS_PROTOCOL_IRB_V. Users with Organization-based access may see only the records that they are authorized to access based on the RESPONSIBLE_ORG.
  • STATUS pertains to the protocol (not to a review, amendment, or request for continuation). It indicates whether or not the protocol is approved for use. If the protocol has yet to be reviewed, its STATUS indicates where it is in the review process. Further details are available here.
  • When creating a report including the protocol's title, note that PROTOCOL_TITLE (the full title) may be up to 4,000 characters long. SHORT_TITLE stores a brief version of the protocol's title.
  • PROJECT_FUNDED is a flag that indicates whether the research specified in the protocol is funded by, or associated with, a grant or contract. The information stored in this flag is whatever was entered by the person that submitted the protocol. A better source of information on funding is the PennERA Proposals data collection. Further details are available here.
  • When reporting on protocol sponsors, be sure to select the data elements that meet your needs.
    • The protocol may have up to four funding sponsors: PRIMARY_SPONSOR, SECOND_SPONSOR, THIRD_SPONSOR, and FOURTH_SPONSOR. These data elements store the PennERA sponsor codes that identify the agencies, organizations, companies, or persons providing funds for the research specified in the protocol.
    • The REGULATORY_SPONSOR is the PennERA sponsor code for the agency, organization, company, or person primarily responsible for initiating and overseeing the research and ensuring that the study complies with research standards and federal regulations. This is not necessarily the same as the PRIMARY_SPONSOR.
    • The IND_SPONSOR is the name of the investigator or entity that is the sponsor of the Investigational New Drug (IND) being referenced for the research.
    • If there is a billing source for IRB-related fees for industry sponsored research,
      • INDUSTRY_SPONS_NAME is the name of the billing source for IRB-related fees for industry sponsored research.
      • INDUSTRY_SPONS_CRO_NAME is the name of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site.
      • INDUSTRY_SPONS_CRO_BILL indicates whether the bills are sent to the sponsor ('SPONSOR') or to the Contract Research Organization ('CRO').
  • SUBJECT_COMPENSATION is a true/false flag that indicates whether subjects will ('T') or will not ('F') be financially compensated for their participation in the research. If the flag is set to 'T', SUBJECT_COMPENSATION_DETAILS stores text describing the compensation that will be offered to subjects. Note: this text is stored in a CLOB. Business Objects queries that use SUBJECT_COMPENSATION_DETAILS will access just the first 4,000 characters of the text in this data element for each record.
  • PI_PENN_ID identifies the Principal Investigator (PI) of the research specified in the protocol. This is not necessarily the same as the PI for the proposal(s) using this protocol.
  • In some cases, it may be helpful to find human subjects protocols that are not attached (linked) to any proposals in PennERA. A protocol with a record in HS_PROTOCOL_IRB_V is not attached to a proposal in PennERA if either of the following is true:
    • the protocol has no records in PENNERA_PROP_REGULATORY_APPR. That is, there are no cases where HS_PROTOCOL_IRB_V.PROTOCOL_NUMBER=PENNERA_PROP_REGULATORY_APPR.REFERENCE_NO and 'Human Subjects' = PENNERA_PROP_REGULATORY_APPR.REGULATORY_TYPE
      • COUNT DISTINCT Proposals (IRB+) is available to Business Objects users in the HS Protocol IRB V folder in the PennERA Proposals and PennERA Balances Universes. COUNT Proposals (IRB+) retrieves the number of distinct proposals that have any PENNERA_PROP_REGULATORY_APPR records for the human subjects protocol specified in the HS_PROTOCOL_IRB_V record. If a proposal has more than one such PENNERA_PROP_REGULATORY_APPR record, that proposal is counted only once. Note:  the proposals included in COUNT DISTINCT Proposals (IRB+) might or might not be attached (linked) to the protocol in PennERA.
    • none of the protocol's records in PENNERA_PROP_REGULATORY_APPR have PROTOCOL_ATTACHED = 'Attached'. That is, there are no cases where HS_PROTOCOL_IRB_V.PROTOCOL_NUMBER=PENNERA_PROP_REGULATORY_APPR.REFERENCE_NO and 'Human Subjects' = PENNERA_PROP_REGULATORY_APPR.REGULATORY_TYPE and 'Attached' = PENNERA_PROP_REGULATORY_APPR.PROTOCOL_ATTACHED
      • COUNT DISTINCT Attached Proposals (IRB+) is available to Business Objects users in the HS Protocol IRB V folder in the PennERA Proposals and PennERA Balances Universes. COUNT Attached Proposals (IRB+) retrieves the number of distinct proposals that have any 'Attached' PENNERA_PROP_REGULATORY_APPR records for the human subjects protocol specified in the HS_PROTOCOL_IRB_V record. If a proposal has more than one such PENNERA_PROP_REGULATORY_APPR record, that proposal is counted only once.

Source

HS-ERA, used at Penn since June, 2008 to handle applications for approval of research protocols involving human subjects.

HS-ERA is the University's Human Subjects Electronic Research Application, which enables members of the research community to create applications for approval of human subjects protocols, electronically route them for approval, and submit them to the University's IRB (Institutional Review Board). HS-ERA feeds the data on the protocols to the Human Subjects module of PennERA, the University's electronic research administration system. PennERA provides support to faculty and research administrators for all sponsored project activity at the University of Pennsylvania.

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