National Cancer Institute Best Practices for Biospecimen Resources
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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. Functionality—General .................................................................................................................................................. 24
B.6.2. Functionality—Identification 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