Study guide
4.6 Biological Samples & Hazardous Goods: Collection, Storage, Disposal & Shipment
ACRP Certified Professional ACRP-CP
Track your progress as you read
Finished sections get a check mark.
1 Chapter 1: GCP Principles, Roles & Delegation
1.1 The Eleven ICH E6(R3) Principles of GCP & Guideline Structure 1.2 Sponsor & Investigator Responsibilities and Delegation of Authority 1.3 Staff Training, Qualifications & Delegation of Authority Log (DOAL) 1.4 CRO Oversight, Vendor Management & Transfer of Regulatory Obligations (TORO)
2 Chapter 2: Essential Records, Source Documentation & Data Confidentiality
2.1 Essential Records Before, During and After the Trial (ICH E6(R3) Appendix C) 2.2 Trial Master File (TMF) and Investigator Site File (ISF) Structure & Inspection Readiness 2.3 Source Documentation, ALCOAC Principles & Medical Record Standards 2.4 Confidentiality, Privacy & Protection of Participant Personal Information
3 Chapter 3: Monitoring, Quality Management & Audits
3.1 Risk-Based Quality Management (RBQM) & Quality Management Systems (QMS) 3.2 Monitoring Visit Types: Site Selection, SIV, IMV, and Close-Out 3.3 Risk-Based Monitoring (RBM), Centralized Monitoring & Source Data Verification (SDV vs SDR) 3.4 Quality Audits, Regulatory Inspections, Non-Compliance & Root Cause Analysis / CAPA
4 Chapter 4: Site Feasibility, Start-Up, Facilities & Laboratory Operations
4.1 Site Feasibility Assessment, Capability Analysis & Investigator Selection 4.2 Contractual Agreements: Clinical Trial Agreements, Budgets, Indemnification & Financial Arrangements 4.3 Site Initiation Preparation, System Access & Regulatory Greenlight 4.4 Protocol Review, Operational Feasibility & Institutional Approvals 4.5 Site Facilities, Equipment Maintenance, Calibration & Trial Supplies 4.6 Biological Samples & Hazardous Goods: Collection, Storage, Disposal & Shipment
5 Chapter 5: Subject Recruitment, Retention & Study Visits
5.1 Subject Recruitment Strategies, Advertising Guidelines & Ethical Constraints 5.2 Screening, Eligibility Verification & Inclusion/Exclusion Adherence 5.3 Subject Retention, Compliance, Visit Scheduling & Protocol Window Management 5.4 Managing Lost to Follow-Up, Subject Withdrawal & Early Termination Procedures
6 Chapter 6: Protocol Compliance, Deviations & Site Close-Out
6.1 Protocol Compliance, Waivers vs. Violations & Deviation Management 6.2 Investigational Site Close-Out Activities & Final Reconciliations 6.3 Record Retention, Archiving Requirements & Post-Trial Responsibilities
7 Chapter 7: Research Ethics, Vulnerable Populations & Research Integrity
7.1 Historical Milestones: Nuremberg Code, Belmont Report & Declaration of Helsinki 7.2 Ethical Principles: Beneficence, Non-Maleficence, Autonomy, Justice & Equipoise 7.3 Vulnerable Populations (Pediatrics, Pregnant Women, Prisoners, Cognitively Impaired, Economically Disadvantaged) 7.4 Conflict of Interest, Research Misconduct & Fraud in Clinical Research
8 Chapter 8: Informed Consent & Institutional Review Boards (IRB/IEC)
8.1 Informed Consent Elements, Process & Ongoing Consent / Re-Consent Requirements 8.2 Assent in Minors & Legally Acceptable Representative (LAR) Requirements 8.3 IRB/IEC Composition, Functions, Review Types (Full, Expedited, Exempt) & Continuing Review
9 Chapter 9: Safety Reporting & Adverse Event Management (ICH E2A)
9.1 Adverse Events (AE) vs. Adverse Drug Reactions (ADR) & Serious Adverse Events (SAE) Definitions 9.2 Causality Assessment, Expectedness, Reference Safety Information (RSI) & SUSARs 9.3 Expedited Reporting Timelines (7-day fatal/life-threatening, 15-day other serious) & Periodic Safety Updates (DSUR)
10 Chapter 10: Investigational Product (IP) Management & Accountability
10.1 Investigational Product Lifecycle, Labeling, Packaging & Blinding Procedures 10.2 IP Shipping, Receipt, Temperature Monitoring, Excursion Handling & Chain of Custody 10.3 IP Storage, Dispensing, Accountability Logs & Destruction/Return Procedures 10.4 Emergency Unblinding (Code Breaking) Protocols & Subject Safety Procedures
11 Chapter 11: Regulatory Frameworks, Submissions & Product Reference Information
11.1 Stakeholders, Regulatory Institutions & Global Frameworks in Clinical Research 11.2 Protocol Submission, Approval & Amendment Processes 11.3 Investigator's Brochure, Instructions for Use & Reference Product Information 11.4 Regulatory Reporting Requirements Before and After Marketing Authorisation
12 Chapter 12: Clinical Data Management, EDC & Electronic Records
12.1 Electronic Data Capture (EDC), eCRF Design & Clinical Data Management Systems (CDMS) 12.2 Computerised Systems, Data Governance & Audit Trails (ICH E6(R3) Annex 1 §4) 12.3 Data Validation, Edit Checks, Discrepancy / Query Management & Resolution 12.4 Medical Coding (MedDRA, WHO Drug), SAE Reconciliation, Data Transfer & Database Lock
13 Chapter 13: Trial Design, Biostatistics, Data Monitoring & Transparency
13.1 Phases of Clinical Research (Phase 0, I, II, III, IV) & Translational Medicine 13.2 Study Designs: Parallel, Crossover, Factorial, Adaptive & Non-Inferiority / Equivalence 13.3 Randomization Schemes, Stratification, Blinding Methods & Minimizing Bias 13.4 Endpoints (Primary, Secondary, Surrogate, Composite), Sample Size & Biostatistical Concepts (p-values, CI, ITT vs PP) 13.5 Interim Analyses, DSMB/IDMC Oversight & Efficacy and Safety Evaluation Milestones 13.6 Trial Registration, Results Transparency & Communicating Results to Participants
4.6 Biological Samples & Hazardous Goods: Collection, Storage, Disposal & Shipment
Key Takeaways Explain This Topic AI
The ACRP-CP Exam Content Outline names the International Air Transport Association (IATA) explicitly as the standard for handling hazardous goods, materials and biological samples.
Category A infectious substances ship as UN2814 (affecting humans) or UN2900 (affecting animals only) under Packing Instruction 620 and require a Shipper’s Declaration for Dangerous Goods.
Category B substances ship as UN3373 "Biological Substance, Category B" under Packing Instruction 650, use triple packaging, and require no Shipper’s Declaration.
Dry ice is itself a Class 9 dangerous good shipped as UN1845; the package must vent carbon dioxide, and the net weight of dry ice in kilograms must be marked.
Consent defines the boundary of sample use — samples may only be retained, exported or used for future research to the extent the participant specifically agreed.
Last updated: August 2026
Biological Samples & Hazardous Goods
Quick Reference: The laboratory manual is the operational source of truth for samples. It specifies tube types, volumes, processing steps, timing, storage temperatures, labelling and shipping conditions. Where the laboratory manual and a coordinator's habit disagree, the laboratory manual wins; where the protocol and the laboratory manual disagree, that is a discrepancy to escalate to the sponsor, not to resolve locally.
Why this is tested
The ACRP-CP Exam Content Outline carries two knowledge statements on this material: 2D, "Standards for handling hazardous goods, materials, and biological samples (e.g., International Air Transport Association (IATA))" in Domain 2, and 4I, "Sample collection, storage, disposal, and shipment requirements" in Domain 4. It is one of the few places where the outline names an external standards body by name.
The sample lifecycle
Stage What must be right Common failure
Collection Correct tube and additive, correct order of draw, correct volume, correct timing relative to dose Under-filled citrate tube invalidates coagulation results
Processing Time from draw to spin, centrifuge speed and duration, temperature, aliquot volumes Sample left at ambient beyond the stability window
Labelling Participant code, visit, sample type, date and time of collection — never the participant's name Name written on a cryovial destined for a central laboratory
Interim storage Correct temperature, monitored and alarmed, correct orientation Aliquots stored at −20 °C when the manual requires −70 °C
Shipment Correct classification, packaging, marking, documentation, courier and timing Shipping on a Friday to a laboratory closed at the weekend
Analysis Receipt confirmed, condition on arrival recorded, results returned and reviewed Sample rejected on arrival, nobody notices for six weeks
Retention or destruction Only as consent and protocol permit Samples retained for "future research" nobody consented to
Classification: the decision that drives everything else Is the material known or reasonably expected to contain a pathogen?
- │
- ├── NO, minimal likelihood pathogens are present
- │ └─► EXEMPT HUMAN SPECIMEN
- │ Triple packaging still required; mark "Exempt human specimen"
- │
- └── YES ──► Is it capable of causing permanent disability, or
- life-threatening or fatal disease in otherwise healthy
humans or animals?
- │
- ├── YES ──► CATEGORY A
- │ UN2814 (affecting humans)
- │ UN2900 (affecting animals only)
- │ Packing Instruction 620
- │
- └── NO ──► CATEGORY B
- UN3373 "Biological Substance, Category B"
- Packing Instruction 650
Most routine clinical trial samples — serum, plasma, urine, whole blood for pharmacokinetics or safety chemistry from participants with no suspected high-consequence pathogen — travel as Category B (UN3373) or as exempt human specimens .
Category A versus Category B side by side
- Feature Category A (PI 620) Category B (PI 650)
- UN number UN2814 humans / UN2900 animals only UN3373
- Proper shipping name "Infectious substance, affecting humans/animals" "Biological Substance, Category B"
- Triple packaging Required Required
- UN specification (performance-tested) packaging Required Not required
- Drop test 9 m 1.2 m
- Puncture and water-immersion tests Required Not required
- Shipper's Declaration for Dangerous Goods Required Not required
- Hazard label Class 6.2 infectious substance label UN3373 diamond mark
- Triple packaging, in every case
Primary receptacle — leakproof, holding the specimen itself.
Absorbent material — between primary and secondary, sufficient to absorb the entire liquid contents.
Secondary packaging — leakproof.
Outer packaging — rigid, with an itemised list of contents placed between the secondary and outer layers.
Either the secondary or the outer packaging must be rigid.
Category B specifics worth remembering
Primary receptacles for liquids must withstand a 95 kPa internal pressure differential.
For liquids, no more than 1 litre per primary receptacle and no more than 4 litres per outer package ; for solids, no more than 4 kg per outer package .
The UN3373 diamond mark must be at least 50 mm on each side, with lines at least 2 mm wide and characters at least 6 mm high, and the words "Biological Substance, Category B" adjacent to it.
The smallest external dimension of the outer packaging must be at least 100 mm .
Full name, address and telephone number of both shipper and consignee on the outer packaging.
Dry ice
Dry ice is not merely a coolant — it is a dangerous good in its own right.
Shipped as UN1845 , proper shipping name "Dry ice" or "Carbon dioxide, solid", Class 9 , Packing Instruction 954.
The package must permit release of carbon dioxide gas . A sealed airtight outer container is a rupture and asphyxiation hazard, not a better package.
The net weight of dry ice in kilograms must be marked, along with the Class 9 label and the UN1845 identification.
Dry ice goes outside the secondary packaging, and interior supports must keep the secondary packaging in position after the dry ice sublimates.
Exam Watchout: A UN3373 shipment needs no Shipper's Declaration — but if it travels on dry ice, the dry ice component still carries its own Class 9 marking and air waybill entry. Candidates who memorise "Category B needs no paperwork" get this wrong.
Training and responsibility
The shipper — in practice the site staff member who packs and releases the package — bears responsibility for correct classification, packaging, marking and documentation. The courier does not assume it.
IATA requires competency-based training and assessment for personnel who prepare dangerous goods shipments, with recurrent training within 24 months .
Only individuals who hold current certification and are on the delegation record for the activity may pack and release shipments.
Training certificates are essential records and are reviewed at monitoring visits and inspections.
Chain of custody
Every transfer of a sample must be traceable, because an unexplained gap makes the result unusable:
Requisition form identifying participant code, visit, sample type, collection date and time.
Collection and processing log at the site, recording who drew, who processed and when.
Shipment manifest listing each sample in the box, plus courier airway bill number and dispatch date/time.
Receipt confirmation from the laboratory, including condition on arrival — temperature indicator status, integrity, whether any sample was rejected.
Reconciliation : the site checks that every sample shipped was received and analysed, and follows up gaps. This is a close-out activity as well as an ongoing one.
Exam Watchout: Sample receipt confirmations are frequently filed unread. If a laboratory reports a sample as haemolysed, insufficient or thawed on arrival, that is a finding requiring action — repeat collection where the protocol allows, a deviation record, and a root cause analysis if it recurs.
Consent defines the boundary
A sample is not simply a site asset. What may be done with it is bounded by what the participant agreed to:
Protocol-specified analyses — covered by the main consent.
Retention beyond the trial and future unspecified research — require the participant to have positively agreed, usually via separate optional tick boxes.
Genetic or genomic analysis — commonly a distinct consent element with its own disclosures.
Export to another country — must be described in the consent and be permitted by the applicable framework and any required import/export permit.
Withdrawal — a participant may withdraw permission for future use of stored samples; the site must have a route to have the remaining samples destroyed and to document that destruction.
Disposal of samples and of contaminated consumables follows the protocol, the laboratory manual and institutional biohazardous waste procedures, and is documented.
Realistic exam scenario
Scenario: A coordinator prepares a Friday afternoon shipment of frozen plasma aliquots to a central laboratory two time zones away. She packs the cryovials in a foam shipper with dry ice, seals the outer box with tape all around to keep the cold in, writes the participants' initials and dates of birth on the vials so the laboratory can match them, applies a UN3373 diamond mark, and books a standard courier for Monday morning collection.
Evaluation — five separate failures:
Sealing the box airtight violates the venting requirement for dry ice (UN1845, Class 9). Subliming carbon dioxide must be able to escape or the package can rupture.
No dry ice marking. The Class 9 label, UN1845 identification and the net weight of dry ice in kilograms are missing.
Participant initials and dates of birth on the vials breach confidentiality — samples are labelled with the participant code , never with identifiers.
Friday dispatch for Monday collection means the dry ice will largely sublimate before the samples move, and the laboratory may be closed on arrival. Shipping days must be coordinated with the laboratory's receiving schedule.
Chain of custody is incomplete if no manifest accompanies the box and no receipt confirmation is chased.
Correct actions: repack in a vented dangerous-goods-compliant shipper with the required dry ice quantity for the transit time; apply the UN3373 mark, the Class 9 dry ice label with net weight, and both shipper and consignee details; relabel the vials with participant codes only; hold the shipment until a day that matches the laboratory's receiving window; enclose the manifest; confirm receipt and condition on arrival; and document the near-miss with a CAPA covering shipper training and a shipping-day schedule.