FAQ

The YODA team decided to standardize our approach to Conflict of Interest. This stems from the ICMJE’s decision to standardize their form.
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No, the DUA needs to be printed, signed, and then scanned to yodap@yale.edu.

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The term “User” encompasses both the name of the individual applying for the data and that individual’s affiliation. Both items should be included in the first section of the DUA. In addition, complete “User” contact information must be provided in Section 11.12 of the DUA.

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No, all investigators will be transferred the complete data set of all rhBMP-2 clinical trials- no modifications will be made to provide more specified or limited data sets to individual investigative teams.collapse
No, a SCOPUS ID is not required. However, please provide your SCOPUS ID if you have one.collapse
Yes, a Conflict of Interest statement is required for all team members.collapse
Yes, click here for an example proposal.collapse
  1. Mail one signed copy to:
    Yale University
    47 College Street, Suite 203
    New Haven, CT 06510
    Attn: Grant and Contract Administration
  2. Mail a second signed copy to:
    Harlan Krumholz, MD
    Yale Center for Outcomes Research and Evaluation (CORE)
    1 Church Street, Suite 200
    New Haven, CT 06510
    Attn: Yale University Open Data Access (YODA) Project
  3. Email a signed copy along with the rest of your application materials to yodap@yale.edu.
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Once your registration survey and Data Use Agreement Training are complete, please submit the following as attachments to an email sent to yodap@yale.edu:

  1. Conflict of Interest statement for all team members (click here for form)
  2. IRB Documentation for one of the following:
    1. Certificate of IRB approval
    2. Notification of waiver of full IRB review/approval
  3. Signed Data Use Agreement (click here for DUA)
  4. Research Study Protocol—which includes project specific aims, main and secondary outcomes of interest and analysis plan, and timeline (click here for a sample proposal).
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Yes, a notification will be sent upon receipt. A second notification will be sent stating whether additional material is required or your application is undergoing review.collapse
No, data will be transferred via the Yale File Transfer Service. Once your application has been approved, you will receive instructions for downloading the data. These instructions and a link to the data will be sent to the email address that you provide in your registration information.collapse
Yes, every approved protocol will be posted on the YODA Web site.collapse
The DUA expires one year from the date of approval. The DUA may be subsequently renewed additional times for one-year periods.collapse
The data is only available in SAS format.collapse
YODA does not provide any technical or statistical support.collapse
No, there is no sharing of data with 3rd parties that are not listed on your application.collapse

In the US, an Institutional Review Board (IRB) performs a review of research proposals. This review board may go by a different name in other countries, such as an Ethics Board, but its purpose is to review protocols to evaluate risk to human subjects. Since the Medtronic data is de-identified, an IRB is likely to exempt the study from review and provide an exemption letter.

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No, only the Principal Investigator needs to complete the training.
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The data was de-identified by Medtronic and certified as such by an independent 3rd party. The data use agreement (DUA) forbids any use of data that will result in re-identification of research participants.
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No. The current YODA data sharing policy only permits for transfer of data via the Yale secure FTP site.

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The data sharing policy and DUA restrict data access to one year. However, data users may 1) renew their application which would extend their agreement for subsequent years and/or 2) maintain the data for a total of 5 years should the data user publish their findings in a peer-review journal. The rationale for the latter is that the data user may be required to reanalyze the data to duplicate findings.

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