MyRHC Compliance index

NCI

NCI Best Practices for Biospecimen Resources

National Cancer Institute best practices for biospecimen resources: governance, collection, processing, storage, retrieval and dissemination of biospecimens.

Clinical Research Biotech & Life Sciences Healthcare Research US

At a glance

Short name
NCI Biospecimen Best Practices
Issuing / stewarding body
NCI
Jurisdiction
US
Also known as / related labels
NCI Best Practices 4th Ed (2026) · ISBER Best Practices 5th Ed · CAP Biorepository Accreditation Program

What this entry covers

The NCI Best Practices for Biospecimen Resources, published by the National Cancer Institute’s Division of Cancer Treatment and Diagnosis, outline governance principles for biospecimen resources, including ethical, regulatory, legal and policy considerations, and operational and technical best practices for NCI-supported biospecimen resources. They cover biospecimen collection, processing, storage, retrieval and dissemination, quality assurance and quality control, biosafety, and data management. They are guidance, not a regulation: NCI states that biospecimen resources are encouraged to align with them.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid; it is not legal advice and is not a substitute for the official text.

Official documentation

Recent changes

  • 2026: NCI released the 4th edition of the NCI Best Practices for Biospecimen Resources, with separate appendices. NCI DCTD

How to use this index entry

  1. Open the official link above (or the agency home if the deep link drifts).
  2. Confirm edition / revision date against your program scope.
  3. Map applicability by sector and jurisdiction listed in the metadata.
  4. Follow related frameworks only after checking their own official sources.

Disclaimers

  • MyRHC does not host proprietary standards text (ISO, some industry bodies).
  • Where standards are paywalled, we link to the publisher’s catalog page.
  • Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice. MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.

Same agencies or sectors — still verify each official source independently.

BMBL

Official

Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition

CDC and NIH advisory guidance on biosafety practices and containment levels for laboratories working with infectious agents and toxins.

CDC NIH Clinical Research Research

CLIA

Official

Clinical Laboratory Improvement Amendments (CLIA)

Federal quality standards for US laboratories testing human specimens, administered by CMS with CDC and FDA under 42 CFR Part 493.

CMS CDC Clinical Research Healthcare

Common Rule

Official

Common Rule (45 CFR Part 46) and IRB Oversight

HHS regulations at 45 CFR Part 46 protecting human research subjects and governing IRB review, overseen by the Office for Human Research Protections.

HHS OHRP Clinical Research Biotech & Life Sciences

GCP

Official

Good Clinical Practice (ICH E6(R3))

International standard for the design, conduct and reporting of clinical trials (ICH E6(R3)), issued by FDA as final guidance in the US.

FDA ICH Clinical Research Biotech & Life Sciences

ICH E6(R3) GCP

Official

ICH E6(R3) Good Clinical Practice

ICH's international guideline for the ethical and scientific conduct of clinical trials, revised as E6(R3), with Annex 2 adopted in June 2026.

ICH Clinical Research Biotech & Life Sciences

NIH Guidelines

Official

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

NIH biosafety requirements for research with recombinant or synthetic nucleic acid molecules at institutions that receive NIH support for such …

NIH Clinical Research Biotech & Life Sciences