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HS_PROTOCOL_IRB_V - Data Element Index

Select a data element to view its definition and its indexed, format, and null values.

 

Data element Definition
BUSINESS_ADMINISTRATOR_PENN_ID

Indexed - no
Format - number
May be null? yes

The Penn ID of the Business Administrator (BA) of the Responsible Org for the protocol (PROTOCOL_NUMBER).

A Penn ID is an 8-digit identification number assigned to an individual by Penn Community system. For example: 77777777. No two persons have the same Penn ID. Note that Penn IDs created in and assigned by Penn Community begin at 10000000. Within the Data Warehouse, the numeric range from 00000000-00999999 is used for individuals who do not yet have a Penn ID in Penn Community, to allow for reliable joins between tables using the PENN_ID column. When a Penn ID appears for the individual appear in Penn Community, it will replace the assigned value throughout the Data Warehouse.

Further information about the Business Administrator is available in the PENNERA_PEOPLE table (in the DWADMIN schema). Note: BUSINESS_ADMINISTRATOR_PENN_ID is stored in NUMBER format, but the format for PENN_ID in PENNERA_PEOPLE is CHAR(8). The Business Objects Universes that include BUSINESS_ADMINISTRATOR_PENN_ID convert it to a character value when joining it to PENN_ID in PENNERA_PEOPLE.

FOURTH_SPONSOR

Indexed - no
Format - varchar2(10)
May be null? yes

The 5-character numeric code that uniquely identifies the fourth listed agency, organization, company, or person (if any) that is providing funds for the research specified in the protocol.

See also PRIMARY_SPONSOR, SECOND_SPONSOR, and THIRD_SPONSOR.

Example: '54144' (NEUROSCIENCE NURSING FOUNDATION).

Values:  Refer to the PENNERA_SPONSOR table 
(in the DWADMIN schema) for values.  
INDUSTRY_SPONS_ADDR1

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the first line of the postal address of the billing source for IRB-related fees for industry sponsored research. The value is stored in mixed case.

See also INDUSTRY_SPONS_ADDR2 and INDUSTRY_SPONS_CITY_STATE_ZIP.

INDUSTRY_SPONS_ADDR2

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the second line of the postal address of the billing source for IRB-related fees for industry sponsored research. The value is stored in mixed case.

See also INDUSTRY_SPONS_ADDR1 and INDUSTRY_SPONS_CITY_STATE_ZIP.

INDUSTRY_SPONS_CITY_STATE_ZIP

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the third line of the postal address of the billing source for IRB-related fees for industry sponsored research. For United States addresses, this is usually the city, state, and ZIP code. For addresses in other countries, this is usually the country and postal code. The value is stored in mixed case.

See also INDUSTRY_SPONS_ADDR1 and INDUSTRY_SPONS_ADDR2.

INDUSTRY_SPONS_CONTACT_NAME

Indexed - no
Format - varchar2(150)
May be null? yes

The name of the contact person at the billing source for IRB-related fees for industry sponsored research. The value is stored in mixed case.

Example: 'Michael Smith'

INDUSTRY_SPONS_CRO_ADDR1

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the first line of the postal address of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. The value is stored in mixed case.

See also INDUSTRY_SPONS_CRO_ADDR2 and INDUSTRY_SPONS_CRO_CITY_ST_ZIP.

INDUSTRY_SPONS_CRO_ADDR2

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the second line of the postal address of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. The value is stored in mixed case.

See also INDUSTRY_SPONS_CRO_ADDR1 and INDUSTRY_SPONS_CRO_CITY_ST_ZIP.

INDUSTRY_SPONS_CRO_BILL

Indexed - no
Format - varchar2(40)
May be null? yes

If there is a billing source for IRB-related fees for industry sponsored research, this indicates whether the bills are sent to the sponsor (see INDUSTRY_SPONS_NAME) or to the Contract Research Organization (CRO; see INDUSTRY_SPONS_CRO_NAME).

Values: 
 
CRO     (bills are sent to the Contract Research Organization)
SPONSOR (bills are sent to the industry sponsor)
[null]  (a billing source for IRB-related fees for industry
         sponsored research has not been specified)
INDUSTRY_SPONS_CRO_CITY_ST_ZIP

Indexed - no
Format - varchar2(150)
May be null? yes

The text of the third line of the postal address of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. For United States addresses, this is usually the city, state, and ZIP code. For addresses in other countries, this is usually the country and postal code. The value is stored in mixed case.

See also INDUSTRY_SPONS_CRO_ADDR1 and INDUSTRY_SPONS_CRO_ADDR2.

INDUSTRY_SPONS_CRO_CONT_PERSON

Indexed - no
Format - varchar2(150)
May be null? yes

The name of the contact person at the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. The value is stored in mixed case.

Example: 'Abigail King'

INDUSTRY_SPONS_CRO_EMAIL

Indexed - no
Format - varchar2(200)
May be null? yes

The e-mail address of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. The value is stored in mixed case.

INDUSTRY_SPONS_CRO_FAX

Indexed - no
Format - varchar2(20)
May be null? yes

The fax number for the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site.

Example: '610-650-1895'

INDUSTRY_SPONS_CRO_NAME

Indexed - no
Format - varchar2(150)
May be null? yes)

The name of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site. The value is stored in mixed case.

See also INDUSTRY_SPONS_CRO_BILL.

INDUSTRY_SPONS_CRO_PHONE

Indexed - no
Format - varchar2(20)
May be null? yes

The telephone number of the Contract Research Organization (CRO) that is the liaison between the sponsor and participating site.

Example: '877-650-1919'

INDUSTRY_SPONS_EMAIL

Indexed - no
Format - varchar2(200)
May be null? yes

The email address of the billing source for IRB-related fees for industry sponsored research. The value is stored in mixed case.

INDUSTRY_SPONS_FAX

Indexed - no
Format - varchar2(20)
May be null? yes

The fax number for the billing source for IRB-related fees for industry sponsored research.

Example: '9195444918'

INDUSTRY_SPONS_NAME

Indexed - no
Format - varchar2(150)
May be null? yes

The name of the billing source for IRB-related fees for industry sponsored research. The value is stored in mixed case.

See also INDUSTRY_SPONS_CRO_BILL.

INDUSTRY_SPONS_PHONE

Indexed - no
Format - varchar2(20)
May be null? yes

The telephone number of the billing source for IRB-related fees for industry sponsored research.

Example: '7812295900'

IND_SPONSOR

Indexed - no
Format - varchar2(200)
May be null? yes

The name of the investigator or entity that is the sponsor of the Investigational New Drug (IND) being referenced for the research specified in the protocol. The value is stored in mixed case.

PI_PENN_ID

Indexed - yes
Format - varchar2(8)
May be null? yes

The Penn ID of the Principal Investigator (PI) for the research specified in the protocol. This is not necessarily the same as the PI for the proposal(s) using this protocol.

A Penn ID is an 8-digit identification number assigned to an individual by Penn Community system. For example: 77777777. No two persons have the same Penn ID. Note that Penn IDs created in and assigned by Penn Community begin at 10000000. Within the Data Warehouse, the numeric range from 00000000-00999999 is used for individuals who do not yet have a Penn ID in Penn Community, to allow for reliable joins between tables using the PENN_ID column. When a Penn ID appears for the individual appear in Penn Community, it will replace the assigned value throughout the Data Warehouse.

Further information about the PI is available in the PENNERA_PERSON table (in the DWADMIN schema).

PRIMARY_SPONSOR

Indexed - no
Format - varchar2(10)
May be null? yes

The 5-character numeric code that uniquely identifies the primary agency, organization, company or person that is providing funds for the research specified in the protocol.

See also SECOND_SPONSOR, THIRD_SPONSOR, and FOURTH_SPONSOR

Example: '09470' (NATIONAL INSTITUTES OF HEALTH)

Values:  Refer to the PENNERA_SPONSOR table 
(in the DWADMIN schema) for values.
PROJECT_FUNDED

Indexed - no
Format - varchar2(1)
May be null? yes

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. Caution: a given protocol may be listed more than once for the same proposal in the PENNERA_PROP_REGULATORY_APPR table.

  • Business Objects users will find that the PennERA Proposals and PennERA Balances Universes include a Class (folder) called HS Protocol IRB V - APPR, which facilitates looking up the protocol's funding information in the PennERA Proposals data collection.
  • Other users may join the PENNERA_PROP_REGULATORY_APPR table to the PennERA Proposals table with the desired funding information, and use a join where DWADMIN.PENNERA_PROP_REGULATORY_APPR.REGULATORY_TYPE = 'Human Subjects' and DWADMIN.PENNERA_PROP_REGULATORY_APPR.REFERENCE_NO = DWSP.HS_PROTOCOL_IRB_V.PROTOCOL_NUMBER(+).
Values: 
 
F      ([false] no, the project is not funded)
P      (project funding is pending)
T      ([true] yes, the project is funded)
[null] (project funding status has not been specified)

Values are stored in DWSP.HS_PROTOCOL_LOV where 
HS_PROTOCOL_IRB_V.PROJECT_FUNDED = HS_PROTOCOL_LOV.LOV_DESC(+) 
and 'PROJECT_FUNDED' = HS_PROTOCOL_LOV.CODE_GROUP(+)
PROTOCOL_NUMBER

Indexed - yes
Format - varchar2(60)
May be null? no

The 6-digit number that uniquely identifies the protocol for research involving human subjects, which has been submitted to the Institutional Review Board (IRB) for approval. The PROTOCOL_NUMBER is used to track the protocol in the HS-ERA system and in the Human Subjects module of the PennERA system.

A protocol describes the method or procedure for carrying out an experiment, investigation, or course of medical treatment.

See also PROTOCOL_TITLE and SHORT_TITLE.

PROTOCOL_TITLE

Indexed - no
Format - varchar2(4000)
May be null? yes

The full title of the protocol for research involving human subjects, which has been submitted to the Institutional Review Board (IRB) for approval. The value is stored in mixed case.

A protocol describes the method or procedure for carrying out an experiment, investigation, or course of medical treatment.

See also PROTOCOL_NUMBER and SHORT_TITLE.

REGULATORY_SPONSOR

Indexed - no
Format - varchar2(10)
May be null? yes

The 5-character numeric code that uniquely identifies the agency, organization, company, or person that is primarily responsible for initiating and overseeing the research specified in the protocol, and ensuring that the study complies with research standards and federal regulations. This is not necessarily the same as the PRIMARY_SPONSOR.

Example: '09470' (NATIONAL INSTITUTES OF HEALTH)

Values:  Refer to the PENNERA_SPONSOR table 
(in the DWADMIN schema) for values.
RESPONSIBLE_ORG

Indexed - yes
Format - varchar2(10)
May be null? yes
The 4-character code that identifies the University organization responsible for the protocol.

Example: 4261 (DM-Rheumatology)

Values:  Refer to the ORG_CODES table (in the DWADMIN schema) for values.
SECOND_SPONSOR

Indexed - no
Format - varchar2(10)
May be null? yes

The 5-character numeric code that uniquely identifies the secondary agency, organization, company or person (if any) that is providing funds for the research specified in the protocol.

See also PRIMARY_SPONSOR, THIRD_SPONSOR, and FOURTH_SPONSOR.

Example: '61167' (FRANK MORGAN JONES FUND)

Values:  Refer to the PENNERA_SPONSOR table 
(in the DWADMIN schema) for values.
SHORT_TITLE

Indexed - no
Format - varchar2(4000)
May be null? yes

A brief version of the title of the protocol for research involving human subjects, which has been submitted to the Institutional Review Board (IRB). The value is stored in mixed case.

A protocol describes the method or procedure for carrying out an experiment, investigation, or course of medical treatment.

See also PROTOCOL_NUMBER and PROTOCOL_TITLE.

STATUS

Indexed - no
Format - varchar2(30)
May be null? yes

Indicates whether or not the protocol is approved for use. If the protocol has yet to be reviewed, the STATUS indicates where it is in the review process.

STATUS reflects the Status shown in the Approval section of protocol's Summary screen in the PennERA Human Subjects module, and the PennERA Protocol Status shown on the Basic Info tab when you view the Protocol Application Form in HS-ERA.

Values:

Accepted
Acknowledged  (The administrators have acknowledged receipt
  of the protocol.)
Acknowledged (CHOP-Penn) (The administrators have acknowledged receipt
  of the protocol. The work described in the protocol is being done
  in cooperation with the Children’s Hospital of Philadelphia.)
Administratively Finalized
Approved  (The board or committee has approved the protocol for use.) 
Approved (CHOP-Penn)  (The board or committee has approved the
  protocol for use. The work described in the protocol is being done
  in cooperation with the Children’s Hospital of Philadelphia.)
Approved Concept in Principle
Approved Contract Pending
Approved Status Withheld
Closed
Completed (All research activity under the human protocol has ended.) Conditional Re-approval (The reviewers have sent the protocol back to the PI for minor revisions. The protocol is active, but no research can be done until approval is granted.) Disapproved (The protocol has been reviewed, and is not approved for use.) Expired (The protocol has been administratively inactivated because its approval period has ended. No research activity is allowed to be conducted under the protocol until the PI files a request to have the protocol reviewed, and the review is approved.) Issue Identified Logged (The protocol has been received but has not yet been scheduled for review.) No Continuing Review Required
Pending (The protocol is pending review.) Tabled (The reviewers have sent the protocol back to the PI for major revisions. The protocol is not yet approved for use.) Terminated (All research activity under the protocol has ended.) Withdrawn Submission (The PI has withdrawn the protocol from consideration.) Withheld Approval (The reviewers have sent the protocol back to the PI for minor revisions. The protocol is not yet approved for use.)
SUBJECT_COMPENSATION

Indexed - no
Format - varchar2(1)
May be null? yes
Indicates whether subjects will be financially compensated for their participation in the research specified in the protocol.
Values: 
 
F      ([false] no, subjects will not be financially compensated for their 
        participation)
T      ([true] yes, subjects will be financially compensated for their)
        participation)
[null] (subject compensation has not been specified; no subjects to
        be recruited)
SUBJECT_COMPENSATION_DETAILS

Indexed - no
Format - CLOB
May be null? yes

If subjects will be financially compensated for their participation in the research specified in the protocol, this text (in mixed case) describes the compensation that will be offered to subjects. The information should include the kind of compensation (such as cash payments, gift cards, or reimbursement for travel), the schedule for compensation per study visit or session, and the total amount for entire participation.

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.

THIRD_SPONSOR

Indexed - no
Format - varcha2 (10)
May be null? yes

The 5-character numeric code that uniquely identifies the tertiary agency, organization, company or person (if any) that is providing funds for the research specified in the protocol.

See also PRIMARY_SPONSOR, SECOND_SPONSOR, and FOURTH_SPONSOR.

Example: '50398' (SIGMA THETA TAU)

Values:  Refer to the PENNERA_SPONSOR table 
(in the DWADMIN schema) for values.

 

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