- Why has the Conflict of Interest Form changed from the original form used when the data was released in June 2013?
- The YODA team decided to standardize our approach to Conflict of Interest. This stems from the ICMJE’s decision to standardize their form.
- Can I use an electronic signature for the DUA?
No, the DUA needs to be printed, signed, and then scanned to firstname.lastname@example.org
- What does the term “User” refer to in the DUA?
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.collapse
- Can I request to receive a portion of the rhBMP-2 data set?
- 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
- Is a SCOPUS ID required to apply for the data?
- No, a SCOPUS ID is not required. However, please provide your SCOPUS ID if you have one.collapse
- Does every team member need to complete a Conflict of Interest statement?
- Yes, a Conflict of Interest statement is required for all team members.collapse
- Do you have an example of a Research Study Protocol that I can use as a template?
- Yes, click here for an example proposal.collapse
- Where do I send my signed DUA?
- Mail one signed copy to:
47 College Street, Suite 203
New Haven, CT 06510
Attn: Grant and Contract Administration
- 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
- Email a signed copy along with the rest of your application materials to email@example.com.
- Mail one signed copy to:
- How do I submit my application?
Once your registration survey and Data Use Agreement Training are complete, please submit the following as attachments to an email sent to firstname.lastname@example.org:
- Conflict of Interest statement for all team members (click here for form)
- IRB Documentation for one of the following:
- Certificate of IRB approval
- Notification of waiver of full IRB review/approval
- Signed Data Use Agreement (click here for DUA)
- 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).
- Will I be notified that my application has been received?
- 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
- Will I receive the data in the mail?
- 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
- Will Yale post my protocol publicly?
- Yes, every approved protocol will be posted on the YODA Web site.collapse
- How long is my DUA valid?
- The DUA expires one year from the date of approval. The DUA may be subsequently renewed additional times for one-year periods.collapse
- Is the data available in any other format besides SAS?
- The data is only available in SAS format.collapse
- Does YODA provide any technical or statistical support?
- YODA does not provide any technical or statistical support.collapse
- May I use this data in a course I am teaching on data analysis?
- No, there is no sharing of data with 3rd parties that are not listed on your application.collapse
- What is Institutional Review Board (IRB)/Ethics Board approval or waiver?
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.collapse
- Does every team member need to complete the Data Use Agreement Training?
- No, only the Principal Investigator needs to complete the training.
- How was the data de-identified?
- 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.
- Did the original permissions through consent allow for research teams outside Medtronic to use the data?
- Would it be possible for the data to be uploaded to a different secure server?
No. The current YODA data sharing policy only permits for transfer of data via the Yale secure FTP site.collapse
- Why will the data only be stored for a year?
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.collapse