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  • NCI Best Practices for Biospecimen Resources

    Biorepositories and Biospecimen Research Branch

    National Cancer Institute

    National Institutes of Health

    U.S. Department of Health and Human Services

    March 2016

  • National Cancer Institute Best Practices for Biospecimen Resources

    2

    Table of Contents

    TABLE OF CONTENTS .................................................................................................................................................................. 2

    INTRODUCTION .......................................................................................................................................................................... 4

    A. SCOPE, APPLICABILITY, AND IMPLEMENTATION .................................................................................................................... 6

    A.1. SCOPE ........................................................................................................................................................................................ 6 A.2. APPLICABILITY AND IMPLEMENTATION .............................................................................................................................................. 6 A.3. FORMAT OF THE NCI BEST PRACTICES .............................................................................................................................................. 6

    B. TECHNICAL AND OPERATIONAL BEST PRACTICES ................................................................................................................... 6

    B.1. BIOSPECIMEN RESOURCE MANAGEMENT AND OPERATIONS ................................................................................................................. 6 B.1.1. Organizational Overview of the Biospecimen Resource .................................................................................................. 6 B.1.2. Biospecimen Resource Personnel .................................................................................................................................... 7 B.1.3. Considerations Related to Planning and Development ................................................................................................... 8 B.1.4. Biospecimen Resource Infrastructure and Space Planning.............................................................................................. 9 B.1.5. Overall Operational Considerations .............................................................................................................................. 10 B.1.6. Biospecimen Resource Evaluation and Assessment ...................................................................................................... 11

    B.2. BIOSPECIMEN COLLECTION, PROCESSING, STORAGE, RETRIEVAL, AND DISSEMINATION ............................................................................ 11 B.2.1. Pre-Analytic and Analytic Variables .............................................................................................................................. 12 B.2.2. Determining Which Biospecimens to Collect ................................................................................................................. 14 B.2.3. Defining Reference Ranges ............................................................................................................................................ 14 B.2.4. Requirement for Evidence-Based Standard Operating Procedures ............................................................................... 14 B.2.5. Methods Research ......................................................................................................................................................... 14 B.2.6. Biospecimen Storage ..................................................................................................................................................... 14 B.2.7. Biospecimen Retrieval ................................................................................................................................................... 16 B.2.8. Shipping Samples ........................................................................................................................................................... 16

    B.3. QUALITY MANAGEMENT .............................................................................................................................................................. 18 B.3.1. Quality Management System ........................................................................................................................................ 18 B.3.2. Quality Assurance/Quality Control ................................................................................................................................ 18 B.3.3. Standard Operating Procedures Manual ....................................................................................................................... 20

    B.4. BIOSAFETY ................................................................................................................................................................................ 21 B.4.1. Biohazard Precautions ................................................................................................................................................... 22 B.4.2. Biosafety Best Practices ................................................................................................................................................. 22 B.4.3. General Laboratory Safety ............................................................................................................................................ 23

    B.5. COLLECTING AND MANAGING CLINICAL DATA .................................................................................................................................. 23 B.5.1. Regulatory Compliance ................................................................................................................................................. 23 B.5.2. Collecting Clinical Data .................................................................................................................................................. 23 B.5.3. Longitudinal Clinical Data.............................................................................................................................................. 24

    B.6. BIOSPECIMEN RESOURCE INFORMATICS: DATA MANAGEMENT AND INVENTORY CONTROL AND TRACKING .................................................. 24 B.6.1. FunctionalityGeneral .................................................................................................................................................. 24 B.6.2. FunctionalityIdentification and Tracking of Biospecimens ........................................................................................ 25 B.6.3. Interoperability .............................................................................................................................................................. 26 B.6.4. Selection of Biospecimen Resource Informatics Management Systems ........................................................................ 27 B.6.5. Validation and Operation of Biospecimen Resource Informatics Systems .................................................................... 28 B.6.6. Regulatory Issues Pertaining to Informatics Systems .................................................................................................... 29

    C. ETHICAL, LEGAL, AND POLICY BEST PRACTICES ..................................................................................................................... 30

    C.1. PRINCIPLES FOR RESPONSIBLE CUSTODIANSHIP................................................................................................................................. 31 C.1.1. Governance ................................................................................................................................................................... 32 C.1.2. Legacy or Contingency Plans ......................................................................................................................................... 32 C.1.3. Policies on Retention ..................................................................................................................................................... 33 C.1.4. Conflicts of Interest ........................................................................................................................................................ 33 C.1.5. Confidentiality and Security ........................................................................................................................................... 33 C.1.6. Public Communication ................................................................................................................................................... 33

    C.2. INFORMED CONSENT .................................................................................................................................................................. 34 C.2.1. Federal Regulations and Guidelines Pertaining to Informed Consent ........................................................................... 34

    C.2.1.4. ......................................................................................................................................................................................... 35

  • National Cancer Institute Best Practices for Biospecimen Resources

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    C.2.2. General NCI Recommendations Pertaining to Informed Consent.................................................................................. 35 C.2.3. NCI Recommendations on Key Informed Consent Elements and Supplementary M

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