Technical and Operational Best Practices

Collecting & Managing Clinical Data

Appropriate annotation of biospecimens is crucial to the overall usefulness of the biospecimen resource as a tool for scientific research (Eiseman et al. 2003) . Biospecimen resources store collected biospecimens using multiple methodologies and procedures. Researchers rely on banked biospecimens for a wide variety of purposes, including target discovery and validation, genetic studies, epidemiologic analyses, and research on prevention or early detection. The data recorded by investigators and biospecimen resources depend on the types of biospecimens collected and the studies' objectives.

B.5.1. Regulatory Compliance

• B.5.1.1.
  Data collection activities should conform to U.S. Food and Drug Administration (FDA) requirements (see 21 CFR Part 11 or the FDA guidance document at http://tinyurl.com/21cfr11) , if and where applicable, so that the data may be cited and/or used in Investigational New Drug and Investigational Device Exemption applications.

B.5.2. Collecting Clinical Data

• B.5.2.1.
  As appropriate for the purpose and nature of the biospecimen resource, relevant clinical data associated with a biospecimen should be collected in accordance with relevant human subject and privacy regulations. The NCI recognizes that data collection is not necessarily the responsibility of the biospecimen resource.
• B.5.2.2.
  Biospecimen resources should employ a uniform, nonredundant vocabulary (e.g., Cancer Biomedical Informatics Grid [caBIG®] common data elements [CDEs]) for clinical data.
• B.5.2.3.
  Biospecimen resources should comply with applicable privacy statutes and regulations and human subjects protection regulations governing the acquisition of biospecimens and associated clinical data (see Sections C.2, Informed Consent, and C.3, Privacy and Confidentiality Protections, for additional information and references) . Clinical data associated with the biospecimens should be used and disclosed only for research in compliance, as applicable, with HIPAA, with U.S. Department of Health and Human Services (DHHS) and FDA human subjects protection regulations, and with applicable State and local laws.
• B.5.2.4.
  Biospecimen resources should track researchers' requests for biospecimens with specific clinical data to guide the refinement of clinical data collection, as appropriate, based on the intended purpose of the resource and if the biospecimen resource is the point of access for biospecimens and associated clinical data. Biospecimen resources should routinely summarize this information and provide it to an entity that maintains and/or collects the clinical data in order to improve the collection of clinical data.