Frequently Asked Questions (FAQs)

  • 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.