Chain-of-Custody Request: Biological Material Transfer Between Research Facilities

1. Section 1: Material Identification & Biological Agent Risk Group Classification

Provide comprehensive identification and risk characterization for all biological materials proposed for transfer. Accurate classification is critical for determining packaging, transport, and containment requirements.

 

Primary Sample Material ID Number

Additional Sample Alias or Internal Tracking Code

Scientific Name of Biological Agent (Genus and Species)

Strain Designation or Isolate Identifier

WHO Risk Group Classification

 

Justification for RG3 classification and specific high-risk characteristics:

 

Justification for RG4 classification and specific high-risk characteristics:

Does this material contain genetically modified organisms (GMOs) or recombinant nucleic acids?

 

Select all applicable genetic modification categories:

Is this agent known to produce toxins or biologically active metabolites?

 

Specify toxin type, concentration, and LD50 if known:

Does this agent exhibit zoonotic potential or cross-species transmission capability?

 

Identify known susceptible host species:

Estimated Infectious Dose (ID50) in laboratory model if known

Infectious Dose Unit

Has this material been inactivated or attenuated?

 

Describe inactivation method, validation protocol, and verification data:

Brief description of material composition and matrix

Total volume or mass of material to be transferred

Volume/Mass Unit

Number of individual containers/vials in shipment

Does material require any special handling beyond standard BSL practices?

 

Specify special handling requirements:

2. Section 2: Sending & Receiving Facility Identification & Principal Investigator Credentials

Complete identification and verification of all facilities and responsible personnel involved in the transfer. International transfers require additional documentation.

 

Sending Institution/Laboratory Full Legal Name

Sending Facility Complete Physical Address

Sending Facility BSL Level Certification

Sending Principal Investigator Full Name

Sending PI Professional Title/Position

Sending PI Email Address

Sending PI Direct Phone/24-Hour Emergency Contact

Sending Facility Biosafety Officer Name

Sending Facility BSO Email and Phone

Is this an international transfer across national borders?

 

Select all applicable international transfer frameworks:

Receiving Institution/Laboratory Full Legal Name

Receiving Facility Complete Physical Address

Receiving Facility BSL Level Certification

Receiving Principal Investigator Full Name

Receiving PI Professional Title/Position

Receiving PI Email Address

Receiving PI Direct Phone/24-Hour Emergency Contact

Receiving Facility Biosafety Officer Name

Receiving Facility BSO Email and Phone

Has the receiving facility confirmed BSL compatibility and adequate containment capabilities?

 

WARNING: Transfer cannot proceed until receiving facility confirms adequate containment capabilities. Please provide documentation of facility upgrade plans and interim safety measures.

3. Section 3: Containment, Cold-Chain Maintenance & Triple Packaging System Inspection

Verify complete compliance with triple packaging system requirements and cold-chain integrity. All packaging must meet UN standards for infectious substance transport.

 

Primary Container Type (Leak-proof Primary Receptacle)

Primary Container Material and Volume Capacity

Is primary container individually wrapped in absorbent material?

 

CRITICAL: Primary containers must be wrapped in sufficient absorbent material to contain entire contents in case of leakage. Transfer cannot proceed without this requirement.

Secondary Packaging Type (Water-tight Leak-proof Receptacle)

Secondary Packaging UN Certification Number

Does secondary packaging contain sufficient absorbent for all primary containers?

Outer Packaging Type (Rigid Protective Outer Receptacle)

Outer Packaging UN Specification Marking

Is complete triple packaging system certified for air transport (IATA PI 620 or PI 650)?

 

Packaging must meet IATA dangerous goods specifications for air transport. Ground-only transport requires alternative documentation.

Temperature Maintenance Requirements During Transit

 

Are validated gel packs or refrigerated shippers used?

 

Refrigerated shipments require validated cooling systems. Ambient shipping not permitted for temperature-sensitive materials.

 

Are dry ice shipments properly labeled and within quantity limits?

 

Dry ice shipments require Class 9 dangerous goods labeling and quantity restrictions per package.

 

Is dry ice packaging sufficient for 96+ hour transit?

 

Is liquid nitrogen dry shipper certified for air transport?

 

Liquid nitrogen dry shippers must be certified as non-pressurized and comply with IATA special provision A152.

Is a temperature monitoring device (data logger) included in shipment?

 

Temperature Logger Serial Number and Alarm Setpoints

Have all exterior surfaces of outer packaging been decontaminated?

 

Decontamination Method and Verification

Are complete shipping documents externally attached in document pouch?

 

All shipping documents must be readily accessible without opening package. Transfer cannot proceed.

I certify that packaging has been inspected and meets all triple packaging system requirements

4. Section 4: Transport Transit Route, Carrier Specifications & Emergency Spill Contingency Protocols

Detailed transport logistics and emergency response preparedness are mandatory for all biological material transfers, especially for Risk Group 3 and 4 agents.

 

Primary Mode of Transport

 

Does carrier accept Category A infectious substances (UN 2814/2900)?

 

Many commercial airlines restrict Category A infectious substances. Alternative carrier required.

 

Provide courier authorization credentials and justification for hand-carry:

Carrier Company Name and Account Number

Carrier Emergency Contact Number (24-hour)

Scheduled Shipment Departure Date and Time

Estimated Total Transit Duration (hours)

Will shipment transit through intermediate handling facilities or customs checkpoints?

 

List all intermediate handling points and estimated dwell times:

Is shipment equipped with GPS real-time tracking?

 

GPS Tracking Device ID and Monitoring Platform

 

EMERGENCY SPILL CONTINGENCY - Complete for all Risk Group 2, 3, and 4 materials

 

Has a written Emergency Action Plan (EAP) been provided to carrier?

 

Carrier must receive written Emergency Action Plan before accepting shipment. Transfer cannot proceed.

Spill Response Kit Contents and Location During Transit

24-Hour Emergency Contact for Spill Response (Primary)

24-Hour Emergency Contact for Spill Response (Secondary)

Nearest Qualified Decontamination Facility to Transit Route

Has carrier personnel received biohazard spill response training?

 

Carrier must demonstrate competency in infectious substance spill response. Provide training certificates or select alternative carrier.

Communication Protocol in Case of Transit Delay, Temperature Excursion, or Spill Event

Are there any geopolitical restrictions or sanctions affecting this transfer route?

 

Describe compliance measures and alternative routing:

5. Section 5: Institutional Biosafety Committee (IBC) Clearance, Risk Assessment & Final Authorization Sign-Off

Final authorization requires documented IBC approval, comprehensive risk assessment, and sign-off from all responsible authorities. Transfer cannot proceed without complete documentation.

 

Sending Facility IBC Approval Reference Number

Sending Facility IBC Approval Date

Sending Facility IBC Approval Expiration Date

Does sending IBC approval specifically authorize this material transfer?

 

Separate IBC amendment or new approval required. Transfer cannot proceed.

Receiving Facility IBC Approval Reference Number

Receiving Facility IBC Approval Date

Receiving Facility IBC Approval Expiration Date

Does receiving IBC approval specifically authorize receipt and possession of this agent?

 

Receiving facility must obtain specific IBC approval for this material before transfer can proceed.

Has a comprehensive Material Transfer Agreement (MTA) been executed between institutions?

 

MTA must be in place before transfer. Standard MTA templates are available through UBMTA or individual institutional technology transfer offices.

Upload complete risk assessment documentation for this transfer

Choose a file or drop it here
 

Does this transfer involve any dual-use research of concern (DURC) considerations?

 

Describe DURC mitigation measures and oversight committee review:

Have all personnel involved in packaging and transport received agent-specific safety training?

 

Training records must be documented and available for inspection. Transfer cannot proceed.

Final Packaging Inspection and Sign-off Timestamp

I certify that all information provided is accurate and complete to the best of my knowledge

I acknowledge that incomplete or inaccurate information may result in transport delays, regulatory violations, or biosafety incidents

I confirm that emergency response procedures have been communicated to all parties and are readily accessible during transit

Sending Principal Investigator Digital Signature

Sending Facility Biosafety Officer Digital Signature

Receiving Principal Investigator Digital Signature (Pre-receipt Acknowledgment)

Receiving Facility Biosafety Officer Digital Signature (Pre-receipt Verification)

Final IBC Administrative Review and Authorization Timestamp

Institutional Biosafety Committee Chair or Designated Reviewer Signature

Final Authorization Reference Code

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