Table of Contents

• B.1. Biospecimen Resource Management and Operations
  • B.1.1. Organizational Overview of the Biospecimen Resource
  • B.1.2. Biospecimen Resource Personnel
  • B.1.3. Considerations Related to Planning and Development
  • B.1.4. Biospecimen Resource Infrastructure and Space Planning
  • B.1.5. Overall Operational Considerations
  • B.1.6. Biospecimen Resource Evaluation and Assessment
• B.2. Biospecimen Collection, Processing, Storage, Retrieval, and Dissemination
  • B.2.1. Pre-Analytic and Analytic Variables
  • B.2.2. Determining Which Biospecimens to Collect
  • B.2.3. Defining References Ranges
  • B.2.4. Requirement for Evidence-Based Standard Operating Procedures
  • B.2.5. Methods Research
  • B.2.6. Biospecimen Storage
  • B.2.7. Biospecimen Retrieval
  • B.2.8. Shipping Samples
• B.3. Quality Management
  • B.3.1. Quality Management System
  • B.3.2. Quality Assurance/Quality Control
  • B.3.3. Standard Operating Procedures Manual
• B.4. Biosafety
  • B.4.1. Biohazard Precautions
  • B.4.2. Biosafety Best Practices
  • B.4.3. General Laboratory Safety
• B.5. Collecting and Managing Clinical Data
  • B.5.1. Regulatory Compliance
  • B.5.2. Collecting Clinical Data
  • B.5.3. Longitudinal Clinical Data
  • B.5.4. Informatics to Support the Tracking of Data
• B.6. Biospecimen Resource Informatics: Data Management and Inventory Control and Tracking
  • B.6.1. Functionality—General
  • B.6.2. Functionality—Identification and Tracking of Biospecimens
  • B.6.3. Interoperability
  • B.6.4. Development of Biospecimen Resource Informatics Management Systems
  • B.6.5. Selection of Biospecimen Resource Informatics Management Systems
  • B.6.6. Validation and Operation of Biospecimen Resource Informatics Systems
  • B.6.7. Regulatory Issues Pertaining to Informatics Systems

• C.1. Principles for Responsible Custodianship
  • C.1.1. Governance
  • C.1.2. Legacy or Contingency Plans
  • C.1.3. Policies on Retention
  • C.1.4. Conflicts of Interest
  • C.1.5. Confidentiality and Security
  • C.1.6. Public Communication
• C.2. Informed Consent
  • C.2.1. Federal Regulations and Guidelines Pertaining to Informed Consent
  • C.2.2. General NCI Recommendations Pertaining to Informed Consent
  • C.2.3. NCI Recommendations on Key Informed Consent Elements and Supplementary Materials
  • C.2.4. Issues Pertaining to Discontinuation of Participation in Research
  • C.2.5. Considerations for Use of Pediatric Biospecimens
• C.3. Privacy and Confidentiality Protections
  • C.3.1. Federal Regulations Pertaining to Privacy
  • C.3.2. NCI Recommendations Pertaining to Privacy and Confidentiality
• C.4. Access to Biospecimens and Data
  • C.4.1. General Principles for Access Decisions
  • C.4.2. Research Plan
  • C.4.3. Access Policies
  • C.4.4. Models of Sustainability
  • C.4.5. Availability of Biospecimens
• C.5. Intellectual Property and Resource Sharing
  • C.5.1. Material Transfer Agreements
  • C.5.2. Inventorship
  • C.5.3. IP Rights
  • C.5.4. Licensing
  • C.5.5. Data and Resource Sharing
• C.6. Conflicts of Interest
  • C.6.1. Investigator Financial COIs
  • C.6.2. Institutional Financial COIs
  • C.6.3. Nonfinancial COIs