Create a HIPAA-compliant Data Sharing Plan annex that reconciles genomic sequencing outputs from multi-site oncology consortiums with IRB-approved de-identification protocols and controlled-access repositories like dbGaP

Generate create a hipaa-compliant data sharing plan annex that reconciles genomic sequencing outputs from multi-site oncology consortiums with irb-approved de-identification protocols and controlled-access repositories like dbgap for Scientific Research and Development Services industry

Scientific Research and Development Services

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Upload current IRB-approved data use agreements, MTAs, and collaborative research agreements from all participating consortium sites
Select the specific types of genomic sequencing outputs to be shared under this plan
Specify the approved de-identification standard for genomic and clinical data
Designate the primary controlled-access repository for data deposition
Specify when genomic data will be available for approved external researchers
Identify the consent model used with patient participants
List specific regulatory requirements affecting data sharing (e.g., FDA IND numbers, foreign national restrictions, tribal sovereignty matters)
Define the approval process for data access requests
Describe the communication protocol for notifying participants and sites about data sharing activities