I am seeking summary-level data for a specific trial or trials - can I request that the Data Partner conduct the analyses?
The YODA Project is facilitating external investigator access to clinical trial data being made available by its Data Partners. This access allows external investigators to conduct their own independent analyses of the data. Requests for Data Partners to conduct analyses are generally out-of-scope due to resource limitations, but will be considered on a case-by-case basis depending upon circumstances and rationale.
Are all the available data listed on the YODA Project website?
All of the trials listed on the website are available for sharing with external investigators following approval of a research request. Data from additional trials may also be available for sharing; however, trials not listed on the website have not yet been reviewed to determine if there might be issues which would slow or prevent sharing with external investigators. If there is a particular trial of interest that is not listed on the Trials page, submit an inquiry. If it is possible to share the requested data externally, then the data will be made available upon review and approval of a full data request, and once the appropriate de-identification process is completed. If the data cannot be released, then the reason why they are not available will be provided to the requestor. Refer to the YODA Project Data Release Policies and Procedures (Section 4) for further information.
What is the difference between a CSR Summary and a full CSR?
A full Clinical Study Report (CSR) is a comprehensive overview of a clinical trial that, in general, numbers between 50 and 500 pages and provides information on the background and rationale for the trial, a complete description of the study sample, design, intervention and main outcome measures, as well as a thorough provision of the results of the primary and secondary efficacy endpoints and safety. A CSR Summary is a brief overview that, in general, numbers between 5 and 20 pages and summarizes the study plan and results, including a numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc.
Are Users required to pay a fee for accessing data through the YODA Project?
No. All data are provided free of charge.
What if my proposed research is already being conducted by one of the YODA Project Data Partners?
The YODA Project will notify requestors if their proposed research is already being conducted by a Data Partner. The decision as to whether or not to proceed is solely that of the requestor.
What if a similar Research Proposal has already been submitted to the YODA Project by another requestor?
Requestors are encouraged to review approved requests’ Research Proposals to determine if similar research projects are already under way. The decision to proceed is solely that of the requestor, but is encouraged by the YODA Project given the need for reproducible science.
The product I am interested in is under litigation- can I still submit a request for data?
You may request any clinical trial data from partnering Data Partners, regardless of litigation status. However, it may be that certain data cannot be shared for various reasons, including reasons related to litigation. This decision will need to be made on a case-by-case basis. The YODA Project will notify the requestor of the reason a data set is not approved for sharing.
Do the Informed Consents signed by patients participating in clinical studies from which data are requested allow for sharing of data with external researchers?
Patients, investigators, and sites who agree to participate in clinical trials are critical partners in advancing medical knowledge. Sharing of data for the advancement of science and medicine is an important goal and permits patients who participate in trials to help other patients. Data Partners are committed to ensuring patient privacy is maintained when data from clinical trials are shared and to making certain that the spirit of informed consents signed by patients is honored and that data are shared for research that will advance public health in a way which will protect patient confidentiality. This may limit the ability to share data in some instances (refer to the YODA Project Data Release Policies and Procedures [Section 1] for further information). Upon approval of a data request, researchers will be granted access to participant-level study data that are devoid of personally identifiable information; current best guidelines for de-identification of data will be used.
What supporting documentation are available for each trial?
The specific supporting documentation available depends on the trial and may include any or all of the following: collected datasets, annotated CRFs, data definition specifications, protocols with amendments, analysis datasets, statistical analysis plans, and/or full clinical study reports. Each individual trial page lists the supporting documentation for that trial.
What is the process for submitting a data request to the YODA Project?
Researchers will need to review the YODA Project Policies and Procedures, identify trials of interest, and login to create a new data request. Additional details are specified in the submission instructions.
I am an employee of a Data Partner sharing data through the YODA Project- do I follow this data request process?
No, this process is for researchers who are not affiliated with/employed by a Data Partner that is collaborating with the YODA Project, nor one of their partner companies or contracted vendors. For all Data Partner affiliates, please utilize your established internal processes for gaining access to data sets for further research purposes.
I am affiliated with Yale University- do I follow this data request process?
Yes, all interested investigators that are external to the Data Partner, including those based at Yale University (the site of the YODA Project), must follow the YODA Project data request process.
Is there an example of a Research Proposal that I can use as a template?
Yes, a template research proposal with instructions is available. Investigators can also review approved research proposals as examples.
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 as this will allow tracking of submitted data requests using an established unique identifier. A Scopus ID # is the unique author identifier from Elsevier’s Scopus database, an abstract and citation database of the peer-reviewed biomedical literature. Any individual who has published an article or indexed conference abstract will have automatically been assigned an ID # by Elsevier.
Does every team member need to complete a Conflict of Interest statement?
Yes, a Conflict of Interest statement is required for the Principal Investigator and all Key Personnel. Key Personnel are those who will have access to the data or who will analyze and/or report on findings from use of the data.
Does every team member need to complete the Data Use Agreement Training?
The Principal Investigator and any Key Personnel who will have data access need to complete the training.
Does the Data Use Agreement Training need to be completed for every data request?
No, the Principal Investigator and Key Personnel only need to complete the training for their first data request (unless otherwise determined by the YODA Project).
Will I be notified when my data request has been received?
Yes, a notification will be sent to the email address provided during account creation upon data request receipt. A second notification will be sent stating whether additional materials are required or your data request is undergoing review.
I am a Research Assistant on my project- can I complete the data request on behalf of the PI?
Any team member besides the Principal Investigator can complete the data request. However, when an account is created with the YODA Project, the PI’s information must be entered under Account Details. Otherwise, the PI will not be listed correctly in the data request. Any team member’s email address can be entered under Account Details to ensure all communications are sent to the most appropriate person.
What criteria will be used to review, and who will make the decision on whether or not my Research Proposal will be approved?
The YODA Project will evaluate Research Proposals to ensure that the proposal has scientific merit, in that 1) the scientific purpose is clearly described; 2) the data requested will be used to create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health; and 3) the proposed research can be reasonably addressed using the requested data. If the YODA Project is unable to verify the scientific merit of the proposal, two independent peer reviews will be solicited by investigators with sufficient clinical expertise in the broader scientific community who are unaffiliated with the Data Partner or the YODA Project. Upon return of the independent, external reviews, the YODA Project will meet with at least one member of the YODA Project Steering Committee, who will also have independently reviewed all materials, in order to make a final decision to grant or deny data access. Refer to the YODA Project Data Release Policies and Procedures (Section 3) for further information.
I have a question regarding a data request I submitted/plan to submit to the YODA Project- who should I contact?
Questions regarding data requests can be sent to email@example.com.
I submitted a Research Proposal to the YODA Project and it was approved. If I write additional proposals, do they need to be approved by the YODA Project as well?
Yes, each individual Research Proposal needs to be submitted to the YODA Project, regardless of whether previous proposals were approved.
What if my institution has questions about or changes to the DUA?
The DUA has been prepared after considerable deliberation and negotiation between Yale University and the Data Partner, in order to best facilitate access to these data for external investigators. Please note that changes can only be made in exceptional circumstances, when required by Federal or State law. Any requested changes will need to be identified using Track Changes and reviewed by the Yale University Office of Sponsored Projects (OSP), as well as the Data Partner. Please contact firstname.lastname@example.org with any questions.
Can I use an electronic signature for the Data Use Agreement (DUA)?
No, the DUA needs to be printed, signed, and then emailed to the YODA Project (email@example.com) once notification is received from the YODA Project that your Research Proposal was approved.
How long is my DUA valid?
There is an expiration date of one year after signing the DUA, which can be renewed additional times for one-year periods if a project is ongoing. Upon project completion, investigators will destroy all copies of the data (if applicable) and supporting documentation. Investigators shall provide certification evidencing such destruction within 30 days of the expiration date. If an investigator’s publication is accepted, rights to use the data are retained for verification of the publication and to respond to inquiries regarding the publication for five (5) years from acceptance. The data cannot be used for additional analysis. Any additional analyses will require a new application for data access to the YODA Project.
How long will it take to access the requested data once a data request has been approved?
The time required to make data available is dependent on several factors, including how many requests are received at a given time, the number of trials requested, whether External Review is required to evaluate the scientific merit of the proposal, whether the data requested are in an electronic format that has been de-identified and is ready for sharing with external investigators, and the time required to appropriately de-identify the data. After any clarifying information is received from the requestor, the aim is to make a decision regarding approval within 30 days, and, once the investigator has returned the signed DUA, to provide access to the data within an additional 30 days.
How will I access the data?
The method by which data will be made available will depend on the Data Partner. One possible method will involve data being made available to approved requestors via a password-protected personalized account on a secure (Safe Harbor) data sharing platform. For those Data Partners preferring this method, access will be granted to a maximum of three researchers per approved data request. All relevant clinical trial data and supporting documentation will be made available via this platform. Data will remain on the secure Safe Harbor platform and will not be downloadable or copied. However, relevant associated materials, such as clinical study reports and protocols, will be downloadable from the secure Safe Harbor platform. In addition, requests granted solely for redacted complete CSRs will be distributed directly, without access through the secure Safe Harbor platform.
Another possible method for providing data access to approved requestors involves transfer of data directly to the requestor via a secure electronic data transfer system (after the DUA has been signed by all parties). Depending on the system, these data may need to be downloaded in order to be used.
I received data through the secure data sharing platform. Can I download these data to my personal computer?
No, data made available on the secure data sharing platform will not be able to be downloaded or copied. All work on the data must take place within the secure platform.
Will I be able to download the supporting documentation for analysis of participant-level data (e.g., case report forms, protocols, CSRs)?
Yes. While participant-level data will remain on the secure platform and will not be able to be downloaded or copied, relevant associated materials, such as clinical study reports and protocols, will be downloadable from the secure platform. All supporting documentation will need to be destroyed upon DUA expiration.
What if I want to use different analytical tools to perform my analyses, in addition to Stata?
Researchers will have access to Stata, R, RStudio, Notepad, and OpenOffice. If needed, researchers will be able to upload additional data sets to the secure platform. Researchers may also request that additional analytical packages be made available on the secure data sharing platform and the YODA Project will work with the Data Partner to determine whether this is possible. The YODA Project will work with researchers to ensure that projects can be conducted within the platform.
How do I report a possible safety concern found during data analysis?
Any possible safety concern that arises from data analysis should be reported directly to the Data Partner immediately for further evaluation and reporting to appropriate Health or Regulatory Authorities as necessary. Appropriate contact information is provided in the DUAs.
May I use these data in a course I am teaching on data analysis?
No, data cannot be accessed or shared with third parties that are not listed on your data request. This precludes providing data to students as part of teaching and education efforts.
Does the YODA Project provide any technical or statistical support?
The YODA Project does not provide any technical or statistical support. For analytical support, the YODA Project can facilitate contact between Data Users and Data Partners, if consultation is desired on the part of the Data User and sufficient resources are available on the part of the Data Partner.
Will the Data Partner know the identity of requestors?
The data request review process will be blinded to both YODA Project reviewers and Data Partners. Not until data access is granted will the YODA Project post the requestor’s identity, the Research Proposal, a summary of the Data Partner Due Diligence Assessment, any scientific reviews from external investigators or the YODA Project Steering Committee, and the YODA Project’s decision to grant or deny data access.
What is the relationship between the YODA Project and Data Partners?
The YODA Project is an independent, academic organization partnering with Data Partners, removing the perception of influence over access. The YODA Project reviews requests and associated registration materials to ensure that all required information is completely submitted, and is committed to facilitating external access to these data for scientific purposes. Data Partners have given the YODA Project full jurisdiction to make decisions regarding data access.
Will the YODA Project post my Research Proposal publicly?
Yes, every proposal will be posted on the YODA Project website, regardless of approval status, along with the Principal Investigator’s name, a summary of the Data Partner Due Diligence Assessment, any scientific reviews from external investigators or the YODA Project Steering Committee, and the YODA Project’s decision to grant or deny data access. An overview of submitted data requests is available, and the list of approved data requests is made publicly available. Research results and/or publications will also be posted on the YODA Project website as soon as they are available.
I am a Data Partner interested in partnering with the YODA Project- what should I do?
For inquiries related to partnering with the YODA Project to share clinical trial data, please contact firstname.lastname@example.org.