1 / 9

Biorepository

Biorepository. Definition : A repository that collects , processes , stores , and distributes biospecimens to support future scientific investigations, assuring quality at every step

amal-jenkins
Download Presentation

Biorepository

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Biorepository • Definition: A repository that collects, processes, stores, and distributesbiospecimens to support future scientific investigations, assuring quality at every step • Mission of LCH Biorepository: Biobanking of specimens that directly support the research of investigators at LCH • NOT to bank samples from every patient seen at LCH • NOT to perform specific analyses • NOT to commercialize the resource

  2. Current Status • Existing Tissue Bank (~11,300 samples) • Supports cooperative group trials and studies using anonymized samples • Distributes 65 samples annually • Access database with manual entry • Liquid samples (blood) • Clinical research specimen processing • Robust service • Managed 160 studies in 2013 • Processes 361 research requisitions/month • Residual specimens policy • No banking

  3. Why a Biorepository? • There are growing demands for this to support clinically relevant translational research • There is a growing ability (and willingness) to couple this with clinical data • Recruitment of key faculty • Unsanctioned specific “biorepositories” are springing up at LCH • Places the institution at risk when investigators move • Unable to document compliance

  4. Collection • FY14 Goals • To establish Freezerworks as the infrastructure for banking both tissue and liquid samples that have been prospectively collected for research purposes • To establish the policies and practices supporting this • Linking with clinical data elements in a manner that is compliant • Bar-coding • Option of PI “ownership”, consent/assent information, date for anonymization, retention

  5. Processing • Where appropriate, to utilize quality-tested processing steps to minimize variation due to sample handling and to facilitate long-term storage • FY14 Goals • To establish and validate the procedures for processing prospectively collected blood to yield stable sample types

  6. Storage • FY14 Goals • To create an inventory system for all sample types using Freezerworks • To investigate the options for future freezer space

  7. Distribution • Purpose: Retrieving samples, assuring appropriate distribution and annotating distribution • FY14 Goals: • To create an IRB-dependent distribution system that allows for permission-driven allocation and annotation • To modify existing specimen retrieval form • To work with the OSP and IRB to ensure that all prospectively collected samples occur through this mechanism

  8. Quality • Biorepositories are regulated by CAP and ISBR • FY14 Goal: • To investigate the requirements for CAP certification • To prepare for CAP certification in FY15 or FY16

  9. Operations • Shannon Haymond, Director of Research • Gwendolyn Mendak, Senior Clinical Practice Manager • Michelle Havinga (CP) • James Bellis(AP) • Pilots • Tissue: COG protocols • Blood: Being developed • Oversight: Quarterly Steering Committee Meeting

More Related