Relative registration forms should be filled when clinical data is used. Relative forms include registration form for data entry of Biobank and registration form for data out of Biobank.
Documentation Required For the clinical data
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Supporting Documentation Requirement |
Research dataset Biospecimens associated clinical data |
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Summary of research plan (protocol) |
Required |
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IRB review (from applicant’s institution) |
Written approval from the requestor’s IRB must be submitted stating that the IRB has either a) performed a review of the project and issues an approval, or b) declared that the research project is exempt from review. |
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Online request form |
Required; Application form for the use of Biobank Database; Registration form for the use of Biobank Database |
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Signed Informed consent |
Required |