What is it? Why is it important?
For the planned analysis, the distribution aim is to guarantee that:
- BM remains traceable and identifiable (e.g. source, donor)
- BM characteristics of interest remain preserved (e.g. defined sample transport procedures)
- Staff safety remains protected (e.g. leak-proof containers, staff safety trainings)
- Laws and regulations related to the sharing of BM and HrPD is complied with (e.g., MTA, intellectual property rights, donor consent
- Rapid delivery: once retrieved, BM becomes negatively impacted if exposed to sub-optimal conditions and temperatures (e.g. RNA/DNA/protein degradation or alteration, decrease in cell viability).
- Transport conditions: Temperature fluctuations (e.g. thawing of samples and degradation of cells or molecules of interest), vibrations and acceleration (e.g. transported on foot, train, plane, truck) threaten optimal BM properties
- Documentation: For subsequent downstream analysis, traceability of BM during distribution provides important BM quality information. In the event of sample and data sharing, MTA/DTA documents are completed
- Compliance with national laws and international requirements: the destination country complies with data protection laws; staff have a required IATA certificate (required for shipments on dry ice)
Other events that carry the risk of exposing BM to less than optimal temperatures are:
- BM retrieval from freezer: in order to retrieve samples, the freezer is opened exposing not only required samples but also all other stored BM. Set-up sample retrieval procedures that limit freezer exposure to higher temperatures and consequently unwanted temperature fluctuations
- Selective retrieval of BM from a storage box or storage of BM in a box already containing BM: a storage box might contain additional not retrievable samples. These samples carry the risk of being exposed, for a given amount of time, to less than optimal temperatures. Ensure to place the box on dry ice in order to protect samples that must be returned to the freezer.
What do I need to do?
Define sample distribution procedures. Aspects to consider include:
- The correct identification of selected BM
- The transport temperature (TT) (e.g. maintaining the storage temperature during the whole distribution process)
- The packaging material and safety requirements:
- Ensure optimal TT (e.g. secondary container, dry ice, ice pack, dry shipper)
- Prevent unwanted damage to BM (e.g. shake and/or light proof container)
- Protect personnel from unwanted BM contamination.
- Required documentation:
- Shipping-log listing all BM distributed, the person responsible for BM identification and packaging/shipping, the date and time of distribution preparation, the transport temperature and the recipient
- If BM is distributed internationally, customs declarations are required
- BIMS update to document the removal of BM from the biobank
- Define procedures for the request of BM (e.g., electronic request of samples by researchers)
- Create shipping-log form to be filled-in by staff responsible for BM distribution (e.g. list of BM with identifiers and sample type, collection date, date & time of packaged BM, transport conditions, person responsible for BM packaging)
- Ensure staff is properly trained and adhere to required distribution conditions (e.g. IATA, safety measures)
In the event BM distribution is outsourced to an external partner ensure:
- Transport processes are compliant with sender and recipient standards
- Set-up a service level agreement (e.g. contract) that defines expected services and responsibilities
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Shipping log
Material Transfer Agreement 3.0
- Master legal document
- Project agreement
Swissethics – see in particular
- Topic / Biobanks and data registries (Material transfer agreement)
IATA – see in particular
- IATA Manuals
LTrV/OTrA – see in particular
- Transport by air ordinance
SDR-ADR – see in particular
- Transport by road ordinance
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 7.3 Reception and distribution of biological material and associated data