> For the complete documentation index, see [llms.txt](https://docs.labii.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.labii.com/applications/hospital-and-clinical-systems/clinical-trial-management.md).

# Clinical Trial Management

Labii Clinical Trial Management helps research hospitals, central laboratories, biobanks, and sponsor teams run clinical studies with operational control and specimen-level traceability. The application unifies study setup, site coordination, coded participant management, protocol visit scheduling, biospecimen processing, aliquot storage, shipment receiving, and disposition records in a single configurable workspace.

By connecting clinical-trial records with shipment intake, controlled storage, and downstream laboratory workflows, the application reduces manual reconciliation work and keeps study teams aligned across collection sites and testing facilities. Every participant code, visit, sample, derivative aliquot, storage location, discrepancy, and quality event remains linked through a complete audit trail.

Whether you are supporting observational studies, interventional trials, translational research, or regulated biobanking programs, the [Clinical Trial Management](https://www.labii.com) application gives your organization a practical framework for compliant, end-to-end study execution in Labii.

## Use Cases

### Multi-Site Clinical Study Operations

* Set up protocols, study arms, milestones, and site-specific procedures
* Track site activation, training, contacts, and enrollment readiness
* Coordinate visit schedules and specimen requirements across participating sites
* Maintain operational visibility for sponsors, coordinators, and central laboratory teams

### Participant and Visit Management

* Register coded participants without exposing direct identifiers in operational tables
* Schedule protocol visits, windows, and required collection tasks
* Capture visit completion, missed visits, deviations, and rescheduled appointments
* Link participant events to sample collections, consent status, and study milestones

### Biospecimen Processing and Aliquot Tracking

* Record accessioning, centrifugation, extraction, labeling, and derivative creation steps
* Create aliquots with parent-child relationships and quantity tracking
* Document chain of custody from collection through processing and storage
* Connect biospecimen records to analytical workflows and test results

### Shipment Receiving and Reconciliation

* Receive kits and clinical samples from external collection sites
* Verify shipping conditions, contents, and temperature compliance on arrival
* Reconcile expected versus received specimens at the shipment, visit, and participant levels
* Open discrepancy records for missing, damaged, mislabeled, or out-of-window samples

### Controlled Storage and Inventory Oversight

* Assign processed specimens and aliquots to freezers, racks, boxes, and positions
* Monitor reserve quantities, storage status, and hold flags
* Support retention policies, controlled access, and destruction approvals
* Maintain full traceability for retrieval, transfer, and disposal events

### Quality and Compliance Management

* Document specimen quality control checks, acceptance criteria, and exceptions
* Track protocol deviations, data discrepancies, and corrective actions
* Preserve audit-ready records for GCP, CAP, CLIA, HIPAA-aligned, and 21 CFR Part 11 workflows
* Provide evidence for inspections, sponsor reviews, and study closeout

## Getting Started

{% stepper %}
{% step %}
Navigate to **Clinical Trial Management** from the Labii applications menu or your organization's application dashboard
{% endstep %}

{% step %}
Configure the core study framework:

* Create studies, protocols, and study arms
* Define participating sites and site contacts
* Set participant coding rules and subject identifier formats
* Build protocol visit schedules and collection requirements
  {% endstep %}

{% step %}
Prepare biospecimen operations:

* Configure specimen types, processing workflows, and aliquot rules
* Set up receiving forms for inbound clinical shipments
* Define storage hierarchies such as rooms, freezers, shelves, racks, boxes, and positions
* Create discrepancy and quality control categories
  {% endstep %}

{% step %}
Assign user roles for study managers, site coordinators, accessioning staff, laboratory technicians, quality reviewers, and storage managers
{% endstep %}

{% step %}
Import or register active sites, coded participants, and baseline visit schedules so teams can begin study operations immediately
{% endstep %}
{% endstepper %}

{% hint style="info" %}
Use coded participant identifiers in operational tables and keep direct subject identifiers in restricted-access records only. This approach helps protect privacy while preserving study traceability.
{% endhint %}

## Configuring Studies and Participating Sites

Set up the study structure before enrolling participants or receiving clinical specimens.

{% stepper %}
{% step %}
Open the **Studies** table and click **+ Add** to create a new clinical study record
{% endstep %}

{% step %}
Enter study design information:

* Study title, short code, and sponsor
* Protocol number and amendment version
* Study phase, disease area, and enrollment targets
* Start date, projected closeout date, and status
  {% endstep %}

{% step %}
Create participating site records with operational details:

* Site name, code, and institution
* Principal investigator and coordinator contacts
* Activation status and training completion
* Site-specific collection windows or shipping schedules
  {% endstep %}

{% step %}
Define protocol visit schedules:

* Screening, baseline, treatment, follow-up, and unscheduled visits
* Allowed visit windows and milestone rules
* Required forms, collections, and procedures per visit
* Expected specimen types and quantities per visit
  {% endstep %}

{% step %}
Save the study and link each site to the protocol so Labii can drive site-specific operational views and task lists
{% endstep %}
{% endstepper %}

## Managing Coded Participants and Protocol Visits

Use coded participant records to connect subject activity, visit status, and sample collection without exposing unnecessary identifiers.

{% stepper %}
{% step %}
Navigate to **Participants** and click **+ Add** to register a coded participant
{% endstep %}

{% step %}
Record participant enrollment data:

* Participant code and screening number
* Linked study and participating site
* Cohort, treatment arm, or randomization group
* Enrollment date, consent status, and current participant status
  {% endstep %}

{% step %}
Generate or assign the participant's protocol visit schedule:

* Planned visit dates based on study rules
* Visit windows and overdue thresholds
* Required specimen collections and assessments
* Site responsibilities and visit notes
  {% endstep %}

{% step %}
Update each visit as activity occurs:

* Mark completed, missed, canceled, or rescheduled visits
* Document deviations and reason codes
* Capture visit-level comments and attachments
* Link visit completion to specimens collected at that encounter
  {% endstep %}

{% step %}
Review participant timelines to confirm visit compliance and identify upcoming collections that require kit preparation or shipment planning
{% endstep %}
{% endstepper %}

## Receiving Clinical Shipments and Accessioning Specimens

Use structured receiving records to connect inbound shipments to studies, sites, visits, and expected specimens.

{% stepper %}
{% step %}
Open the **Receiving** workflow and create a new shipment receiving record when a package arrives
{% endstep %}

{% step %}
Capture receiving details:

* Shipment identifier and carrier tracking number
* Sending site and shipment date
* Receiving date, time, and receiver
* Packaging condition and temperature-monitor status
  {% endstep %}

{% step %}
Verify the shipment contents against protocol expectations:

* Confirm participant and visit identifiers on each specimen
* Check specimen type, quantity, labeling, and container integrity
* Record collection date and collection window compliance
* Identify missing, extra, damaged, or compromised materials
  {% endstep %}

{% step %}
Register accepted specimens into Labii and link them to the correct study, site, participant, and visit records
{% endstep %}

{% step %}
Create discrepancy records for exceptions such as missing tubes, broken vials, incomplete paperwork, temperature excursions, or unmatched participant codes
{% endstep %}
{% endstepper %}

{% hint style="warning" %}
Do not move specimens into long-term controlled storage until receiving checks, chain-of-custody review, and required quality assessments are complete.
{% endhint %}

## Processing Biospecimens and Managing Aliquots

Track every processing step so derivative specimens remain connected to their original collections.

{% stepper %}
{% step %}
Open the accepted specimen record and start the processing workflow assigned to that specimen type
{% endstep %}

{% step %}
Record processing metadata:

* Processor, date, and time
* Processing method and protocol version
* Pre-analytical conditions such as spin time, thaw events, or stabilization steps
* Source volumes, yields, and comments
  {% endstep %}

{% step %}
Create aliquots or derivatives as needed:

* Generate unique aliquot IDs
* Define derivative type such as plasma, serum, PBMC, DNA, RNA, or extracted protein
* Record aliquot volumes, concentrations, and counts
* Preserve parent-child links between the original specimen and all derivatives
  {% endstep %}

{% step %}
Apply labels and assign interim or final storage locations for each aliquot
{% endstep %}

{% step %}
Release processed material to downstream testing, biobanking, or shipment preparation once quality and reconciliation checks are complete
{% endstep %}
{% endstepper %}

## Controlling Storage, Reconciliation, and Disposal

Maintain accurate storage inventories throughout specimen retention, retrieval, transfer, and final disposition.

{% stepper %}
{% step %}
Assign each specimen or aliquot to a controlled storage location with full position detail
{% endstep %}

{% step %}
Track storage attributes:

* Storage temperature and handling requirements
* Freeze-thaw limits and hold flags
* Quantity remaining and reservation status
* Access restrictions for sensitive or limited material
  {% endstep %}

{% step %}
Run routine reconciliation activities:

* Compare expected inventory to physical storage contents
* Confirm box maps, barcode scans, and position assignments
* Investigate missing, duplicate, or incorrectly placed aliquots
* Document reconciliation outcomes and corrective actions
  {% endstep %}

{% step %}
Manage retrievals, transfers, and study closeout activities:

* Reserve specimens for testing or sponsor requests
* Record chain of custody for freezer moves and outbound shipments
* Identify specimens eligible for retention extension or destruction
* Collect approvals and witness documentation where required
  {% endstep %}

{% step %}
Create disposal records that document disposition date, method, approver, witness, and related study or retention policy
{% endstep %}
{% endstepper %}

## Advanced Features

### Quality Control and Discrepancy Tracking

Labii can separate operational intake from formal quality review so teams can investigate issues without losing specimen traceability.

{% hint style="info" %}
This workflow is useful when receiving staff must log issues immediately, while quality teams review root cause, impact, and resolution later.
{% endhint %}

{% stepper %}
{% step %}
Configure discrepancy types such as missing specimen, label mismatch, temperature excursion, hemolysis, insufficient volume, and visit window deviation
{% endstep %}

{% step %}
Create quality review records linked to shipments, visits, participants, or individual specimens
{% endstep %}

{% step %}
Track investigation status, corrective actions, and final disposition decisions until each discrepancy is resolved or approved with justification
{% endstep %}
{% endstepper %}

### Sponsor-Ready Traceability

Labii can connect studies, visits, specimens, aliquots, storage positions, and downstream results so teams can respond quickly to monitoring visits or audits.

{% stepper %}
{% step %}
Build reports and filtered views for protocol compliance, pending visit collections, sample aging, storage utilization, and unresolved discrepancies
{% endstep %}

{% step %}
Use audit trails, version history, and linked records to reconstruct the path of any specimen from collection through final disposition
{% endstep %}
{% endstepper %}

## Troubleshooting

### Issue: Expected specimens do not match what arrived

**Symptoms**: Shipment contents, visit records, or labels do not match protocol expectations. **Solution**:

{% stepper %}
{% step %}
Compare the receiving record against the participant visit plan and shipment manifest
{% endstep %}

{% step %}
Confirm coded participant identifiers, visit names, specimen types, and collection times
{% endstep %}

{% step %}
Register any accepted specimens, then create discrepancy records for missing, extra, or mismatched items so they can be investigated without delaying the rest of the workflow
{% endstep %}
{% endstepper %}

### Issue: Aliquots cannot be reconciled in storage

**Symptoms**: A storage location contains unexpected material, a barcode scan fails, or recorded quantities do not match physical inventory. **Solution**:

{% stepper %}
{% step %}
Review the aliquot's parent specimen history, transfer records, and most recent reconciliation log
{% endstep %}

{% step %}
Verify box position, label readability, and whether the aliquot was moved, consumed, or reserved without an updated status
{% endstep %}

{% step %}
Correct the storage record and document the discrepancy resolution with approver notes if the reconciliation affects controlled inventory
{% endstep %}
{% endstepper %}

### Issue: Study teams need access without exposing direct participant identifiers

**Symptoms**: Coordinators, laboratory staff, or sponsors need operational visibility, but privacy requirements restrict subject-identifiable data. **Solution**:

{% stepper %}
{% step %}
Store direct identifiers in restricted records with limited permissions
{% endstep %}

{% step %}
Use coded participant records and linked study data for operational workflows, receiving, processing, and reporting
{% endstep %}

{% step %}
Audit user roles regularly to confirm only approved personnel can view sensitive subject information
{% endstep %}
{% endstepper %}