Ig repertoire analysis from bulk RNAseq data of frozen ccRCC tumors

Before any access can be granted through EGA, each request shall be jointly reviewed by representatives of the BIONIKK study Sponsor, the Coordinating Investigator of the BIONIKK clinical trial, and designated scientific representatives of the UMR-S 1138 research team at the Centre de Recherche des Cordeliers. For the datasets covered by this Policy, the following persons are designated to review each access request and provide their documented approval: • Eve Lepicard, Scientific Director of ARTIC, representing ARTIC, Sponsor of the BIONIKK study and Data Controller; • Professor Stéphane Oudard, Coordinating Investigator of the BIONIKK clinical trial; • Professor Hervé Fridman, designated scientific representative of UMR-S 1138, Centre de Recherche des Cordeliers; • Professor Catherine Sautès-Fridman, designated scientific representative of UMR-S 1138, Centre de Recherche des Cordeliers; • Each investigator responsible for the scientific analyses underlying one or several datasets covered by this policy. Each access request shall be assessed with regard to: • compatibility of the proposed research with the information and consent provided to BIONIKK participants and with applicable data-protection requirements; • scientific relevance and feasibility of the proposed research; • adequacy and proportionality of the data requested in relation to the stated research objectives; • potential overlap with ongoing or planned research using the same datasets; • appropriate acknowledgement, citation and publication arrangements; • compliance with the applicable Data Access Agreement and with the security, confidentiality, non-reidentification and non-redistribution requirements governing the datasets. Access shall only be granted once the documented approval of all the persons designated above has been obtained. If one or more of the designated reviewers do not approve the request, access shall not be granted unless the disagreement has been resolved in accordance with the governance arrangements applicable to the BIONIKK TLS translational research project. The documented outcome of this review procedure shall then be transmitted to the BIONIKK Translational Research Data Access Committee, which shall record and implement the resulting access decision through EGA. applicable Data Access Agreement.