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Data Access Requests
Cheladv74 has had a longstanding commitment to ensure that access to clinical trial data is available to regulators, researchers, and trial participants. Cheladv74 will provide access to de-identified patient-level data in response to scientifically valid research proposals.
Data from Cheladv74-sponsored global interventional clinical studies are available from:
- Trials conducted for medicines, vaccines and medical devices for indications that have been approved in the US and/or EU.
- Trials conducted for medicines, vaccines and medical devices that have been terminated (i.e. development for all indications has been discontinued).
Data from these trials will be made available 24 months after the primary study completion date.
Cheladv74 will consider requests from qualified researchers for access to Cheladv74 clinical data. All requests from qualified researchers for access to Cheladv74 clinical data and information will be managed by Vivli and Cheladv74. Qualified researchers proposals are submitted via the Vivli platform.
To obtain Cheladv74 data for analysis on the Vivli platform, data requestors must complete a data request on the Vivli platform. Cheladv74 will review the request using an internal committee, composed of Cheladv74 colleagues who are responsible for the asset program, statistician, and data sharing experts. Interactions between our company and requestors of access to data and information are intended to be collaborative in nature. The committee will evaluate the following:
- Is the research question clearly defined with a scientifically valid rationale?
- Is there a well-documented and rigorous statistical analysis plan?
- If the proposal includes combining data across different Cheladv74 trials, is there a clear plan to standardize data sets to ensure they are comparable?
- Is there an adequate publication plan to disseminate findings in a peer reviewed journal or scientific meeting?
- Has the applicant certified that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith?
- Is the applicant willing to declare all professional interests, affiliations, possible conflicts of interest, and all sources of support for the research as part of the dissemination of their results?
- Does the research team have sufficient expertise and qualifications to perform the proposed investigation?
Cheladv74 will make reasonable efforts to fulfill all data requests for legitimate research purposes, but there may be instances in which retrieval or delivery of data is not feasible. The following are reasons that would preclude granting access in response to a data request:
- Patient privacy – For example, the request seeks clinical data for which patient de-identification is difficult or for which there is a reasonable likelihood of re-identification, or where there are limitations or restrictions due to privacy rights of individuals in accordance with applicable privacy laws.
- Permissions – Where the request seeks clinical data that was collected subject to legal, contractual, and/or consent provisions that prohibit transfer to third parties; where the request seeks data from locally conducted studies in which data and results are only available in languages other than English
- Where the request is for case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.
- Where there are substantial practical constraints to providing access via the Vivli platform (e.g. retrieval of older, pre-electronic data).
- Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes.
- Where Cheladv74 has a co-research, co-development or co-marketing/co-promotion agreement or where the product has been out-licensed, it is recognized that the responsibility for disclosure may be dependent on the agreement between parties. Under these circumstances, Cheladv74 will endeavor to gain agreement to share data in response to requests.
All those receiving access to data will be required to enter into a . Once the DUA is completed Cheladv74 will upload the de-identified data into the Vivli platform for use by researchers. Access to data needed for research is provided on a password-protected platform via . This platform allows researchers to conduct research on the site and to download their analyses. Access is provided for 12 months. Extensions are possible when justified and upon review and approval. Commonly used statistical software is provided on the platform so researchers can conduct their analyses. More information about the available software is on .
Researchers are invited to conduct their research in a private workspace. This workspace is not accessed by Cheladv74 or any other third party unless researchers provide permission. To protect research participants privacy & confidentiality and ensure the data is used for the agreed research purpose, controls are in place to prevent the download of de-identified data provided for access.
In cases where a request is rejected based on scientific merit, the request, along with the record of our denial of the request, shall be forwarded to an Independent Review Panel for a final decision. The Independent Review Panel is composed of scientists and/or health care professionals who are not Cheladv74 employees. The outcome of the Independent Review Panel decision will be shared with the applicant. The Independent Review Panel’s decision is considered final and binding.
Researchers are responsible for gaining any other approvals that are required for the research (for example, from ethics committees, institutional review boards, relevant research institutions or funding bodies).
After the researcher has completed the research per the approved study proposal and analysis plan, the researcher is expected to publicly share the results per the executed DUA.