Biospecimen Management

Yale Pathology Tissue Services (YPTS) is a well-established pathology-based Central Tissue Resource Lab that provides comprehensive tissue-related services and material for investigators. This resource is dedicated to providing the maximum amount and quality of human tissue for research without affecting diagnostic quality, accuracy, and safety related to patients. The four lab groups, Clinical Trial Tissue Services Developmental Histology, Specialized Translational Services, and Tissue Procurement and Distribution can assist investigators with most tissue-based research requests.


YCCI staff members are available to help investigators manage biospecimens electronically and develop case report forms for specimen collection. Staff can help investigators utilize OnCore’s Biospecimen Management (BSM) module, which keeps track of sample inventory, collection, processing, storage and distribution in a secure environment. BSM is paired with a Unified Registries Management (URM) module that uses electronic case report forms for research subject registries and is able to track clinical outcomes. This service provides easy access to data while storing them in a HIPAA-secure environment.


YCCI also maintains a storage facility for biospecimens. If you have an IRB-approved protocol for biobanking, clinical research involving specimen collection, or a patient registry and data manager who can collaborate with YCCI data analysts to customize your database, contact Helen Seow, PhD.

Tissue acquisition specific SOP

06 - Tissue acquisition specific SOP

For information of The Yale Tissue Procurement and Distribution Facility (YTPDF) on mission, policies, underlying model, tissue access, annotation, embargo and fee schedule, please refer to following website: http://pathology.yale.edu/research/tissueservices/TPD/TissueProcurementDistribution.aspx

It is essential to perform optimal management of pathology resources including fresh, frozen and formalin-fixed specimen regarding the requests of human specimens for research purpose. All human tissues must be handled in strict compliance with HIPAA regulations, University HIC policies, and diagnostic requirements. All users must recognize and be prepared to assume the responsibilities associated with all aspects of tissue procurement and management.

For each request, a standard operating procedure (SOP) must be drawn up by the requesting investigator. The detailed condition and specific guideline of specimen grossing required should be defined by requesting investigator and attending pathologist in an effect to standardize operating and to keep research tissue sampling under management without jeopardizing diagnosis tissue submission. Personnel from YTPDF will help interested investigators design and optimize SOPs. Terms for specific requests of specimens will be discussed depending on demand, specimen site, and the amount of Pathology participation and manpower required. Negotiations will be conducted by the director of Yale Pathology Tissue Services and overseen and approved by the Tissue Resource Oversight Committee (TROC). 

For investigators whose research projects are not claimed to involve Human Subject, based on institutional HIC guideline, limited information associated with samples will be provided including age range, sex, diagnosis and pathological status (Tumor or Normal).  YTPDF party will assign a new identifier for each SOP specific sample, in the manner that it would not be possible for investigators to identify the corresponding patient-subject directly. For linked tissues, investigators are required to have HIC approval and signed patient consent.

Prior to implementation, drafted SOP must be reviewed and approved by the directors of Pathology service and other appropriate individuals including attending pathologist who supervising specified tissue collection.  Implementation date should be recorded for all procedures.

All data related to tissue collection must be entered into the YTPDF database, which will allow YPTS to manage, keep track of YPTS fresh and frozen tissue biorepositories, and to oversight and coordinate inventories in the distributed banks. 

References:

Yale University, School of Medicine, Yale Pathology Tissue Service website, empty

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Yale University, Human Research Protection Program website, 

http://www.yale.edu/hrpp/forms-templates/biomedical.html