SAFs
: Contents : Data Release Process :
Sample Materials Download
View
the data process flow here.
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Submit request to the SRTR
We encourage you to review all of the information posted on this website about
SAFs. Once you have reviewed the information about what you can obtain through
the use of SRTR SAFs, please complete the Contact Us.
Use the description field to indicate your request for a SAF, and provide some
detail regarding the research to be conducted with the SAF.
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SRTR preliminary review
The SRTR will do a preliminary review based on your brief description for a
request for a SAF. The SRTR will work with you to troubleshoot and anticipate
any potential problems in reaching the approval stage of this process. If
additional information is needed, you will be contacted via email.
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Researcher completes Agreement
When the SRTR has determined that your initial request is plausible through the
use of an SRTR SAF, you will receive a response from the SRTR asking you to
complete an “Agreement For Release Of Data.” With the submission of Agreement,
you must submit a formal research plan (2-3 pgs). You are also asked to
complete a security plan, indicating how the SAFs will be used, stored and
protected.
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If the request requires patient-identifiers,
you need IRB documentation and approval by the S-TAC and PO
a. If you indicated on the Agreement that patient-identifiers (SSN, patient
name, date of birth) were necessary for the specified research, you must obtain
IRB documentation from your institution and submit the documentation to the
SRTR.
b. You also must have approval from the SRTR Scientific Advisory Committee
(S-TAC) and the SRTR Project Officer (PO), both of which will require IRB
documentation for possible approval. The S-TAC meets quarterly throughout the
year and therefore requests for patient-identified data may take longer than
requests for SAFs without patient-identifiers.
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SRTR approval
Upon receipt of the Agreement, research plan, and security plan, the SRTR will
review all components and either approve the request, ask for additional
clarification or possible edits, or not approve the request with specific
reasons. During the approval process the SRTR staff reviews the research
question, looking for a clear and legitimate scientific purpose with sufficient
merit to the transplant community, the appropriate data for study design, and
the security of the data.
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The agreement is signed by all parties
Once approval is granted for the components of the Agreement (including the
research and security plans), the appropriate parties will sign the Agreement.
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SAFs released to researcher
The SAFs are prepared and sent to the address indicated on the agreement. You
will also receive a copy of the signed agreement.
The time to complete a request for SRTR SAFs is at a minimum of 2 months. This
timeframe is based on the details of the request, how many requests for SAFs
are in the queue, security measures, IRB documentation, and the request for
patient-identified data.