A handover ends one part of the work and begins another. Discuss laboratory receipt while planning the project so that samples and their records remain connected. The following concerns coordination, not instructions for packaging, processing or transport.
Who is responsible for what?
Complete a short table for the project before dispatch. One organisation may hold several roles, but agree that explicitly.
| Role | Question to resolve |
|---|---|
| Sponsor or authorised coordinator | Who approves the handover plan and resolves open questions? |
| Dispatching site | Who prepares the inventory and records the actual handover? |
| Transport provider | Who accepts the shipment and reports a delay or deviation? |
| Receiving laboratory | Who confirms readiness to receive and reconciles the samples? |
| Discrepancy owner | Who assesses the impact of a problem and documents the decision? |
This is a suggested discussion structure, not a published allocation of Bessalar’s responsibilities.
Which records should align?
- Versions of the protocol and laboratory manual or other agreed sample instructions.
- Sample inventory and coding rules connecting the shipment to study records.
- Agreed conditions and confirmation of receiver readiness, including a contact if plans change.
- Actual handover, receipt, storage and discrepancy records within the project scope.
ICH M10, Table 1, Sample Tracking addresses sample receipt and condition, inventory, storage and deviations. Determine the specific documentation for the project separately.
What counts as receipt confirmation?
Agree how the receiver confirms both arrival and the reconciliation outcome. For example, decide where missing items, damage, mismatched codes and unavailable transfer-condition records will be recorded. A carrier’s status alone cannot answer those questions.
If a discrepancy occurs, do not replace unknown information with an assumption that conditions were acceptable. This article cannot determine sample suitability. Preserve the records and refer the issue to authorised project personnel through the agreed process.
Where to start
When discussing laboratory support, identify the planned handovers and outstanding questions. Use the feasibility brief for the initial discussion; agree a suitable channel before sharing confidential documents.
Reference checked on 24 October 2026. An independently prepared coordination checklist. ICH M10 is an international reference, not evidence of specific clinic capabilities. No temperatures, durations, packaging specifications or medical procedures are prescribed here.
Questions and answers
Which temperature applies to every biosample transfer?
There is no single condition for all samples. Study documents and relevant stability evidence determine the requirements. Agree temperature, duration and monitoring before dispatch; this article does not prescribe these parameters.
Is a carrier's delivered status enough?
Delivery status does not replace the receiver's reconciliation. Agree receipt confirmation, inventory and condition checks, and the process for recording discrepancies in advance.
See also
Handling and storage of study samples: the pre-analytical stage
In a bioequivalence study the result depends on how a sample is handled before it is measured: the time of collection, centrifugation, freezing, storage temperature and transfer. The clinic processes samples on site — in centrifuges, freezers and refrigerated cabinets; the conditions and times are set by the protocol.
Learn moreWhat to prepare for a study feasibility discussion
Prepare a short feasibility brief covering the study objective, protocol version, participants, procedures, samples and proposed schedule. Mark unknowns as questions: an initial response is not confirmation that a site can deliver the study.
Learn more
How we work: project stages from enquiry to report
A project starts with a synopsis or protocol. We assess feasibility, prepare a proposal, take part in the documents and ethics review, recruit volunteers, run the study under the protocol and transfer samples and data. At every stage it is clear what we do and what is needed from the sponsor or CRO.
Learn more