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Biospecimen Banking

Data abstraction

Overview	Collection Protocols	Biospecimen Procurement	Storage	Data abstraction	Distribution

Investigator initiated linked protocols allow for data abstraction of Protected Health Information by the investigator or research staff as stated in the consent document. Subjects are consented by the investigator and/or research staff.

Pathology initiated linked protocol SaLUTE allows for data abstraction of Protected Health Information by a Department of Pathology research nurses only. Subjects are consented by the Department of Pathology staff in the Pre-Anesthesia Clinic to bank their tissue and access their medical records for a period of 180 days or ten years depending on the patient’s choice. All subjects will remain anonymous to the investigator or staff. A unique case number is assigned to each specimen and only the Biospecimen staff will be able to link the sample to a subject. The Research Nurses in the Department of Pathology will abstraction the clinical data relevant to the researcher’s request. This information is provided to the researcher in a de-identified anonymous format with all PHI removed in accordance with HIPPA standards.

Investigator initiated unlinked protocols does not allow for data abstraction of Protected Health Information by the investigator or research staff. Along with the requested sample the investigator will receive a de-identified pathology report noting the subject’s year of birth, race, gender and year the sample was collected. Pathology initiated unlinked protocol Tissue in Excess provides the investigator a requested sample with a de-identified pathology report noting the subject’s year of birth, race, gender and year the sample was collected only.

Standard Specimen Information available for all specimens

• Patient demographic (year of birth, gender, race)
• Organ type/site
• Procedure: description of medical procedure or surgery type
• Processing Type: Fresh, Snap, OCT, and Paraffin
• Tissue description: Tumor, Normal, Diseased or Adjacent Normal Designation
• Specimen Dimensions (size, weight) and Volumes for body fluids
• Sample numbers associated with the specimen
• Pathology Report

For linked cases de-identified clinical information can be abstracted from Co-Path, Oasis and the medical record in addition to standard specimen information. Next