Clinical Core Query Request Form
Contact: Debbie Gudonis-Senior Research Coordinator
Phone: 215-662-2429
Fax: 215-662-7899
Email: Debbie.Gudonis@uphs.upenn.edu
Type of Service Requested:
 Information from Database
 Specimen from Repository
 Prospective Collection of Patient Material
Briefly Describe Project and Purpose:
__________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Study Inclusion Criteria: (Describe data elements you would like to
gather or characteristics of patients and specimens)
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Specimen Request Number of Vials
Serum
Plasma
Cells
Clinical Core
Query Request Form
Page 2 of 2
Grant Title: _____________________________________________________________
Grant Number: __________________________________________________________
Penn Acct. Number: ______________________________________________________
Affiliated Institution Acct. Number: ________________________________________
IRB Approval Dates: ____/____/____--____/____/____
Name of PI:
_____________________________________________________
Email:
_____________________________________________________________
Phone/Fax: _____________________________________________________________
Name of User: ___________________________________________________________
Email:
____________________________________________________________
Phone/Fax: ____________________________________________________________
Name of BA: ____________________________________________________________
Address: ______________________________________________________________
_____________________________________________________________________
Email:
_____________________________________________________________
Phone/Fax: _____________________________________________________________
Is the purpose of this query for a grant application? __________________________
Will there be a publication in regards to this query? __________________________
Have you previously used the Database and/or Repository? ____________________
Philadelphia VA Medical Center
Combined Data Use/Transfer Agreement Form
Please complete the information and remove (italicized directions) before submission.
Check: Preparatory to Research
Protocol Submission
Project Title:
ID#:_________
PROM #:_________
(Preparatory Research will not have a study ID# or PROM #)
Other Project Titles or Informal References (i.e. Lipid Study, Weight Loss Study, etc.):
1. Brief Project Description:
2. Data to be Identified and Specific Uses:
(Specify the data elements that will be identified.)
3. Persons with Access to the Data:
(Names of all individuals permitted access to the data)
4. Other Entities Identified to which Data may be Disclosed:
(e.g. study sponsor, another IRB, etc.)
The data will not be disclosed either within the VA or outside the VA other than as
permitted by the Agreement or permitted within the applicable protocol.
5. Data Storage: Data must be used, stored, and secured according to the requirements of
the VHA series 1200 Handbooks, other applicable VA and VHA requirements, and as
described in the approved research protocol or as specifically described in the Preparatory to
Research Form.
6. Disposition of Data: All research records are permanent records and will be destroyed
based on the Veterans Health Administration Records Control Schedule 10-1 deposition upon
approval by the National Archives and Record Administration. All research data must be
returned to the PVAMC upon completion of the study or preparatory to research.
7. Any non-compliance with the applicable VA and VHA requirements, other applicable
Federal regulations, or the research protocol as approved by the IRB and R&D Committee(s),
must be reported according to the facility’s policies and procedures and by VHA
requirements. It must also be reported to the investigator or VA employee who allowed the
data to be transferred. If data are from a VA data repository, the data repository administrator
or owner must notify the IRB(s) having oversight responsibilities for the repository in
accordance with the repositories procedures.
8. Any theft, loss, or compromise of the data must be immediately reported to the
investigator’s facility’s ISO, Privacy Officer, the investigator’s supervisor, and others as
stipulated in VA, VHA, and local facility’s requirements. It must be reported to the Privacy
Officer and ISO of the facility from which the data were transferred, in addition to the
investigator or VA employee who allowed the transfer of the data. If data are from a VA
research data repository, the research data repository administrator must notify the IRB
having oversight responsibilities for the repository in accordance with the research data
repositories procedures
9. No effort will be made to re-identify data that are de-identified/coded.
10. Scrambled social security numbers (SSNs) will not be “unscrambled” to reveal the real
SSNs.
11. The following must be provided to the database owner prior to the release of data:
IRB Approval.
________________________________________________________________________
I agree to safeguard all data provided to me and am strictly prohibited from disclosing the
data to persons within VA or outside VA who are not listed on this agreement and
permitted within the protocol for which the data were requested. Other uses of these data
are prohibited without prior notification of and approval by the PVAMC IRB.
__________________________________________
Database Owner
_____________________
Date
ACCEPTED:
__________________________________________
Principal Investigator
_______________________
Date
__________________________________________
ACOS for Research
_______________________
Date
__________________________________________
Privacy Officer
_______________________
Date
__________________________________________
Information Security Officer
_______________________
Date