Background and Purpose of the Addendum Sample Clauses

Background and Purpose of the Addendum. The CAVD DMSA came into effect in 2006. At that time, the Bill & Xxxxxxx Xxxxx Foundation (the “Foundation”) was not funding CAVD Members to undertake clinical trials. Understandably, the DMSA did not include or exclude data sharing terms specific to clinical trials. Under the DMSA as it currently stands, CAVD Members are expected to utilize the services of the BMGF-funded Central Services Facilities (CSFs), which includes two Vaccine Immune Monitoring Consortia that provide standardized assays to characterize humoral and cellular immune responses. Data from these standardized assays are transferred to the Vaccine Immunology Statistical Center (“VISC”), shared with all CAVD Members and ultimately with the broader scientific community at specified times. Though not currently an obligation on CAVD Members, results from assays not performed by the CSFs (but that are funded by the Foundation under a CAVD grant) should also be shared with CAVD Members. This encompasses immunological assays redundant with services available from the CSFs, as well as characterization by the clinical study team of participant specimens using other standardized, qualified or validated assays described in their study plan. Individual grant agreements may also require sharing of all data from assays performed on specimens from a foundation supported clinical study regardless of the source of the laboratory funding. Prior to the initiation of any laboratory or statistical study by the Vaccine Immune Monitoring Centers (“VIMCs”) or VISC, the Vaccine Development Consortium (VDC) will work with the VIMC or VISC, as appropriate, to register the study on the CAVD portal. VDCs acknowledge the importance of consulting with the VISC regarding study design, data format, and data transfer methods, to ensure agreement of data definitions and plans for statistical analyses. Also since 2006, there have been new initiatives launched by the Foundation that change requirements and process for the sharing of data arising from foundation funding. In 2015 the BMGF launched an open access policy which includes a requirement to share the clinical trial data underlying peer-reviewed publications. What follows is background on the foundation’s open access policy, and then details regarding the proposed Addendum to the CAVD DMSA that pertains specifically to the sharing of clinical trials data.
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