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 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 2 National Cancer Institute Best Practices for Biospecimen Resources C.2.2. General NCI Recommendations Pertaining