Biospecimen Management Best Practices

Evaluate compliance with NCI Best Practices and ISBER guidelines for biospecimen collection, processing, storage, and distribution in research biobanks

BiotechHealthcareResearch20 minutes20 questions

1. Consent & Ethics

Are biospecimens collected under IRB-approved protocols with appropriate informed consent?*

NCI BP 1.0: Ethical collection with informed consent or waiver

Do consent forms address future use, data sharing, and return of results?*

ISBER: Broad consent vs. study-specific consent considerations

Are specimens de-identified or coded to protect patient privacy?*

HIPAA compliance for biospecimens: identifiable, coded, de-identified

2. Collection & Processing

Are specimen collection procedures standardized with written SOPs?*

NCI BP 2.0: Standardized protocols reduce pre-analytical variability

Is time from collection to processing/storage documented (warm/cold ischemia time)?*

Critical quality indicator: typically <30 min for tissues, <2 hr for blood

Are specimens labeled with unique identifiers and barcodes?*

ISBER: Unique specimen IDs prevent mix-ups and enable tracking

Do you maintain chain of custody documentation from collection through storage?*

Track specimen handling, aliquoting, and transfers

3. Storage & Preservation

Are specimens stored in validated freezers/cryopreservation systems at appropriate temperatures?*

Liquid nitrogen (-196°C), -80°C, -20°C, 4°C per specimen type

Is temperature monitoring continuous with alarms and backup systems?*

NCI BP 5.0: 24/7 monitoring with emergency response procedures

Are freeze-thaw cycles documented and minimized?*

Repeated freeze-thaw degrades biomolecules; aliquot to single-use volumes

Do you maintain backup power and liquid nitrogen supply for critical storage?*

Emergency preparedness: generators, LN2 delivery contracts, transfer procedures

4. Quality Management

Is a quality management system implemented with documented SOPs?*

ISBER: QMS covering all biorepository operations

Are quality metrics tracked (ischemia time, RNA integrity, cell viability)?*

NCI BP 8.0: Pre-analytical and analytical quality indicators

Do you participate in external quality assessment programs (proficiency testing)?*

CAP Biorepository accreditation: PT for specimen handling

5. Data Management & Tracking

Do you use a Laboratory Information Management System (LIMS) for specimen tracking?*

NCI BP 9.0: Comprehensive data management system

Are clinical/pathological annotations linked to specimens?*

Diagnosis, stage, treatment, outcomes increase scientific value

Is specimen inventory regularly audited to match physical and database records?*

Quarterly inventory reconciliation recommended

6. Distribution & Sharing

Are specimen distribution requests reviewed by a scientific review committee?*

ISBER: Evaluate scientific merit and feasibility

Do you maintain Material Transfer Agreements (MTAs) for specimen distribution?*

Legal agreements governing use, IP, publication, data sharing

Is specimen shipping validated to maintain cold chain and sample integrity?*

Dry ice shipment validation, temperature monitoring during transport

Please answer all required questions to see your results