From scheduled collection to documented outcome.
Two samples from the same visit, each followed through its own workflow.
Scheduled.
The Week 12 visit is booked, so the sample is scheduled: PK plasma, pre-dose, within 30 minutes before the dose, 4 mL K2EDTA, two aliquots, to be placed at minus 80 °C within 60 minutes of collection. In-date collection supplies are reserved.
Scheduled.
The Week 12 visit is booked, so the sample is scheduled: PK plasma, pre-dose, within 30 minutes before the dose, 4 mL K2EDTA, two aliquots, to be placed at minus 80 °C within 60 minutes of collection. In-date collection supplies are reserved.
Collected.
The nurse scans the supplies and participant label and records the collection time as 08:31, 19 minutes before the recorded dose. AQ Labs records the entry time separately and confirms that the collector is authorised for this study.
Collected.
The nurse scans the supplies and participant label and records the collection time as 08:31, 19 minutes before the recorded dose. AQ Labs records the entry time separately and confirms that the collector is authorised for this study.
Processed and stored.
The sample is centrifuged as the lab manual specifies and divided into two aliquots, each with its own identifier. Aliquot 1 is placed in freezer F2, box 4, position A1 and aliquot 2 in position A2 at 09:20, 49 minutes after collection and within the study’s limit.
Processed and stored.
The sample is centrifuged as the lab manual specifies and divided into two aliquots, each with its own identifier. Aliquot 1 is placed in freezer F2, box 4, position A1 and aliquot 2 in position A2 at 09:20, 49 minutes after collection and within the study’s limit.
Shipped and received.
Both aliquots are scanned into a frozen shipment to the central laboratory, with the manifest linked to the site file. Laboratory receipt and analysis status are recorded against each aliquot.
Shipped and received.
Both aliquots are scanned into a frozen shipment to the central laboratory, with the manifest linked to the site file. Laboratory receipt and analysis status are recorded against each aliquot.
Requested.
Safety bloods due at Week 12 are listed with the visit and requested from the local laboratory using its identification requirements.
Requested.
Safety bloods due at Week 12 are listed with the visit and requested from the local laboratory using its identification requirements.
Collected and sent.
Collection time and handover to the laboratory are recorded.
Collected and sent.
Collection time and handover to the laboratory are recorded.
Result recorded.
The result is recorded against the sample, and out-of-range values are highlighted.
Result recorded.
The result is recorded against the sample, and out-of-range values are highlighted.
Reviewed.
The investigator records whether each out-of-range value is clinically significant and signs with re-authentication. The signed review is linked to the participant’s record.
Reviewed.
The investigator records whether each out-of-range value is clinically significant and signs with re-authentication. The signed review is linked to the participant’s record.
How does AQ Labs simplify sample tracking?
It replaces separately maintained trackers with one view of collection supplies, samples and outstanding actions across every study and laboratory.
Illustrative views with fictional data.
Where does clinical trial sample management break down?
Each study brings its own collection schedule, processing limits and laboratory requirements. When supply logs, handling records and laboratory portals are held separately, outstanding work is difficult to identify and handling is difficult to evidence.
Supply availability and expiry
Collection supplies arrive in bulk at study start and their expiry dates must be checked against upcoming visits. Shortages or expired supplies can disrupt a planned collection.
Supply availability and expiry
Collection supplies arrive in bulk at study start and their expiry dates must be checked against upcoming visits. Shortages or expired supplies can disrupt a planned collection.
Incomplete processing records
Collection, processing and storage times recorded after the event make it difficult to confirm that samples met the study’s handling limits.
Outstanding laboratory queries
Queries arriving by email and portal need clear ownership, the sample’s history and timely follow-up while any recollection window remains open.
Delayed result review
Safety results from several laboratories need an organised review process, with outstanding assessments visible to the investigators responsible for them.
What does lab sample management software do for a research site?
It turns each sponsor’s lab manual into defined steps at the bench and keeps one record of every sample until it is analysed, stored or destroyed. AQ Labs covers nine workflows across three stages.
Study laboratory set-up.
The sponsor’s lab manual becomes a versioned sample schedule for each visit and timepoint, with laboratories, accreditation certificates and reference ranges on file. When a new manual version is issued, the changes are shown for review before approval.
Collection supplies and expiry.
Collection supplies are scanned in with lot and expiry date and reserved against booked visits. Expired supplies are blocked from selection in AQ, and reorder suggestions are based on the visits booked.
Visit readiness.
Before each visit, AQ Labs checks that collection supplies are available and in date, that an authorised collector is scheduled and that courier collection is arranged for same-day samples.
Guided collection and processing.
When the visit opens, staff see the samples due for that participant and timepoint in order of draw, with volumes and handling requirements. Processing timers show the time remaining against the study’s limits, and a missed limit is flagged for assessment and documented follow-up.
Storage and temperature.
Each aliquot is recorded to a freezer, rack, box and position, and storage location records are linked to each sample. When a temperature excursion is recorded, AQ Labs identifies every sample stored in the affected unit so that the sponsor’s decision is documented for each one.
Shipments and manifests.
Shipments are built by scanning samples, and only samples for the receiving laboratory and storage condition are accepted. Ship-day and stability checks run before packing, a packing checklist reflects the specimen classification and refrigerant, and the manifest is linked to the site file at courier handover.
Laboratory queries.
Each query is linked to the sample it concerns, with an owner, a due date and the sample’s full history. Any recollection is recorded and scheduled in accordance with the protocol and the instructions of the investigator or sponsor.
Result review.
Where the study requires investigator review, safety results are presented in one review queue across laboratories. Out-of-range values are highlighted, and the investigator records whether each is clinically significant and signs with re-authentication. AQ Labs does not pre-select the assessment.
Reconciliation and destruction.
Expected, collected, shipped and analysed samples are reconciled continuously, with a reason recorded for every difference. Destruction is completed under a two-person control in AQ and produces a certificate.
How does AQ Labs connect to the rest of the study record?
Sample handling depends on the rest of the study: a visit booked within its window, staff trained on the current lab manual, and deviations that reach the quality system. AQ Labs holds the sample record that other AQ modules read, and reads from them in turn. Each module is priced and deployed independently.
A visit booked in the study calendar creates that participant’s sample list and timepoints.
Illustrative, fictional data.
Recorded delegation and training status determine which staff can perform collection, processing, shipping and review tasks.
Illustrative, fictional data.
A missed processing limit can be raised as a deviation and, where needed, a corrective action.
Illustrative, fictional data.
Laboratory certificates, reference ranges, manifests and signed reviews are linked to the site file, with filing and access determined by record type.
Illustrative, fictional data.
Dosing and sampling are held on the same record, so PK sampling times can be read against the recorded dose time.
Illustrative, fictional data.
What changes for the people who handle samples?
Study-specific worklists prepared from each lab manual, with collection times recorded on requisition forms.
Study-specific worklists prepared from each lab manual, with collection times recorded on requisition forms.
Samples due appear when the visit opens, in order of draw, with collection times recorded at the bedside.
Processing limits tracked manually and storage positions held in separate freezer maps.
Processing timers show remaining time against study limits, and every storage position is recorded by scan.
Supply logs, shipment trackers and query correspondence maintained separately for each study.
One view of supplies, shipments and open queries across every study.
Safety reports reviewed across several laboratory systems, with outstanding reviews tracked separately.
One review queue across laboratories, with each assessment signed and linked to the participant’s record.
Sample history assembled from logs, portals and correspondence when requested.
Read-only access to current sample history, queries and manifests.
How does AQ Labs work with laboratory portals and hospital systems?
AQ Labs does not replace the systems laboratories and hospitals use. It gives the site one record of its own sample activity across all of them.
Questions sites ask about AQ Labs.
AQ Labs is the lab sample management module of AQ Platform. It records every sample a trial sends to a laboratory, from the sponsor’s lab manual through collection supplies, collection, processing, storage, shipment and queries to result review where the study requires it, on the same record as the site file.
Not covered here? Write to enquiries@aq-trials.com.
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