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August 26, 2022

Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform

by
Slope

This blog is the third in a series exploring the necessary requirements for an eClinical Supply Chain Management (eCSCM) platform. For an eCSCM platform to optimize a clinical supply chain, there are four categories of requirements: 

  1. Collaboration 
  2. Real-Time Visibility 
  3. Traceable Chain of Custody
  4. Compliance 
This blog will detail the traceable chain of custody requirements for an eCSCM platform.

Biological samples from subjects are the most valuable assets that travel across the clinical trial’s supply chain. Any gap in the knowledge in the biological sample's lifecycle can make the subject non-evaluable and jeopardize overall data integrity. If this happens too often, the overall clinical trial can be at risk. When shipping biological samples, clinical research sponsors must have the data they need to conduct biological sample reconciliation—meaning they have documentation to track a biological sample stored in a biorepository back to the lab that analyzed it, the courier that transported it, the research site that collected it, the lab kit that was used and its lot and serial number, and the lab kit’s distributor and manufacturer. This data allows the sponsor to prove that a biological sample is valid and has not been tainted anywhere along the way. As a result, an online platform must maintain an immutable record of all of the steps a biological sample takes throughout its journey from collection through storage, along with the steps taken by each collaborator, including sponsors, contract research organizations (CROs), research sites, distributors, labs, and couriers. As a result, an eCSCM platform must be able to prove a traceable chain of custody for biological samples, lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, whether in use, transit, or storage.

Traceable Chain of Custody Requirements

Valid biological samples are critical to an effective clinical trial outcome, and an online platform must ensure sponsors can rely on trackable data from lab kits and biological samples. An eCSCM platform must be able to trace biological samples throughout their lifecycle—from collection, registration, shipping, and routing, to lab accession and transfers to biorepository storage for biological sample reconciliation. If the traceable chain of custody requirements for an eClinical Supply Chain Management platform are met, the risk of usable biological sample loss is decreased and overall trial data integrity is increased.

Unusable biological samples can result from any gaps in knowledge of a biological sample’s whereabouts during the chain of custody. Manual biospecimen handling, storage, and coordination are often conducted through spreadsheets, hand-written notes, manual transcription from system to system, and emails. As a result, biological sample reconciliation using data from these manual processes can be prone to errors and time-consuming. Without a strong, defensible audit trail, data integrity can be suspect. 

These traceable chain of custody requirements for an eClinical Supply Chain Management platform are the key to resolving these issues:

  • Biological Sample Tracking
  • Lab Notification
  • Data-enabled Smart Lab Kits
  • Drug and Device Accountability
  • Audit Trails

Biological Sample Tracking

The many steps in a biological sample’s lifecycle provide the opportunity for myriad pitfalls that can threaten a clinical trial’s outcome. Sponsors must have the data to track the complete chain of custody for each individual biological sample. To support this, an online platform must be able to:

  • Capture the collection of a biological sample from a specific subject at each timepoint in their progression through the clinical research study 
  • Register each biological sample as it is taken for tracking and reporting 
  • Generate shipping manifests and maintain documentation of what is included in the shipment of each biological sample
  • Document the packaging and conditions of the shipment for each biological sample
  • Track where each type of biological sample is to be shipped and the receiving days and hours of the receiving location
  • Register each biospecimen as an addition to the research study’s collection of biological samples

When these biological sample tracking requirements are met, collaborators have insights into when, where, and how biological samples are taken, shipped, and stored—reducing the possibility of lost biological samples and increasing the number that can be reconciled. The ability to track biological samples is one of the essential traceable chain of custody requirements for an eClinical Supply Chain Management platform. 

Lab Notification

When a biological specimen arrives at a lab, its viability depends on efficient site processing, shipping, and storage. If labs are unprepared for or unaware of a biological sample arriving, they may not have the right resources available to receive and process them and ensure they get properly stored to maintain the biological sample’s viability. To avoid this, an online platform must:

  • Notify labs that biological sample shipments are on the way and when they will be delivered 
  • Provide a place for labs to record receipt and condition of biological samples

Through this notification feature—one of the traceable chain of custody requirements for an eClinical Supply Chain Management platform—labs are able to perform effective resource planning to make sure the loading dock is open to receive the biological sample and the required technician is available to process the biological sample, increasing valid biological samples that can be properly reconciled.

Data-enabled Smart Lab Kits and Clinical Supplies

Every item used in a clinical trial must have a traceable chain of custody. Without a traceable chain of custody, adhering to federal regulation requirements and Good Clinical Practice guidance, especially in regards to reconciliation, becomes a significant challenge or even impossible. For example, Title 21 CFR Part D 312.57 states that a sponsor shall “maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug” and “retain the records and reports required by this part for 2 years after a marketing application is approved for the drug.”  E6 (R2) Good Clinical Practice recommends that sponsors “oversee the entire clinical trial” and investigators “should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site's trial subjects traceable with an audit trail.”  In other words, lab kits and other clinical supplies must be traceable from their manufacturer to the distributor, to the courier that gets them to the research site, to their arrival at the research site—as should be their use to collect a biological sample. From there, the biological sample must be tracked from collection to packaging and shipping to the lab. Proper reconciliation and regulatory compliance and guidance can be untenable using manual processes and spreadsheets.

The best way to accomplish traceable chain of custody for reconciliation is through labels that are data-enabled. Therefore the traceable chain of custody requirements for an eClinical Supply Chain Management platform include:

  • Barcode labels containing data the system can use to identify and track each item, its lot and serial number, and its contents if any
  • Data-enabled barcodes that are scannable by handheld scanners, which automatically record in the online platform the state of a lab kit or other clinical supply in its lifecycle as well as its location
  • Automatically generating the lab kit and other clinical supply labels to reduce human error

These requirements provide easy, consistent tracking once a lab kit or other clinical supply is used and shipped, and make reconciliation fast and accurate. As a result, more biological samples are likely to be deemed valid for assessing the clinical trial’s results, and far fewer biological samples are at risk of being lost or disqualified, which can lead to a subject being non-evaluable. 

Drug and Device Accountability

It is uniquely important that collaborators be able to track the whereabouts of IP and devices because accounting for their shipment, storage, and dispensation is required to adhere to good clinical practice (GCP). An online platform must be able to:

  • Track the routing of drugs and devices to each research site to assure the proper IP is shipped in the right amounts
  • Record the addition of IP to research site inventory, its storage location, and its dispensation and assignment to subjects
  • Document the administration, reclamation, and destruction of drugs and devices

If these drug and device accountability requirements are met, sponsors will know their IP’s location and that a clinical trial is compliant with GCP for handling of IP.

Audit Trails

It is essential that a complete audit trail that tracks the lifecycle of a biological sample, lab kit, IP, and other clinical supplies is maintained throughout the clinical trial. Any gaps in the documentation of the chain of custody make reconciliation impossible when auditors, monitors, or data managers perform their jobs. An online platform must include an audit trail of:

  • Every action taken by each collaborator at each location throughout the clinical trial 
  • Every biological sample collected and processed, where it was shipped, then analyzed, and stored
  • All items shipped throughout the research study, who shipped the item, the courier used, and the receiving person and location

With this final traceable chain of custody requirement for an eClinical Supply Chain Management platform, collaborators can use this audit trail to ensure reconciliation for a fully traceable chain of custody, so they are ready for scrutiny.

Optimizing Clinical Supply Chain Management 

The eClinical Supply Chain Management platforms’ overall value is optimizing clinical supply chain management. To find out more, read our prior blogs:

Or unlock our Clinical Supply Chain Management Toolkit.

Stay tuned for our next blog, “Compliance Requirements for an eClincial Supply Chain Platform”.

The Slope eClinical Supply Chain Platform 

The Slope eClinical Supply Chain Management platform was designed and developed to meet the traceable chain of custody requirements explored above. These required capabilities include tracking biological samples, notifying labs when shipments are on the way, data-enabled smart lab kits, drug accountability, and audit trails that help with biological sample reconciliation.

To see a live demonstration, contact us to talk to one of our clinical trial solutions experts.

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