Application For An Off Site Tissue Banking Va 10-0436 Page 4
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7G1. Will the key to the code that links the biospecimens to the subject's identity be maintained ONLY at the VA
facility?
YES
NO
G2. If NO, indicate where else a copy of the key will be maintained and why. (Exceptions are not routinely
approved.)
H1. Who has access to the key? (PI, study coordinator, data coordination center director, etc.)
H2. Are any of the people who have access to the key outside of the VA?
YES
NO
H3. If YES, who? (study coordinator, data coordination center director, etc.)
I. How is the key secured at all locations? (locked file cabinet, in a password-protected database that is
encrypted, etc.)
8. INFORMATION ABOUT THE STUDY DATA
A1. Will any data be sent or stored outside of the VA? (Data includes clinical and/or demographic data, as well as
x-rays and scans.)
YES
NO (skip to section 9)
A2. If YES, state where and why it needs to be outside the VA.
A3. If YES, will the data be de-identified? (Please see the definition of de-identified on page 6 of this form.)
YES (skip to section 9)
NO
B. If data leaving the VA is NOT de-identified according to the definition on page 6 of this form, it must be
transferred in a secure manner. Indicate how the data will be transferred (VPN, encrypted e-mail).
Page 4 of 7
VA FORM 10-0436
MARCH 2009
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