Dummy Dose Sample Collection in Clinical Trials: How Sponsors can make Dummy Dose Collection Smarter

In some clinical trials, sponsors require the collection of dummy dose samples from participating investigational sites to confirm that investigational product is being prepared and dispensed in accordance with the pharmacy manual, protocol requirements, and site training materials. While dummy dose collection is sometimes viewed as a routine compliance check, in practice it introduces operational, regulatory, and logistical complexity, particularly in global studies. These activities provide sponsors with direct visibility into site-level dosing behavior and serve as an important mechanism for validating that investigational product handling aligns with study expectations.

Why Dummy Dose Retrieval Is a Clinical Supply Risk Area

Dummy dose sample collection plays a critical role in dosing oversight and patient safety. When executed correctly, it reinforces confidence that investigational product is being handled as intended and that site training has been effective. When delayed or poorly executed, dummy dose retrieval can create blind spots in dosing oversight, introduce uncertainty into site performance assessments, and increase risk related to patient safety and data integrity. For these reasons, dummy dose collection should be treated as a strategic clinical supply activity rather than an administrative task.

Choosing the Right Vendor or Courier for Dummy Dose Collection

One of the most common challenges sponsors face is selecting an appropriate vendor or courier to retrieve dummy dose samples efficiently and compliantly. While multiple options may appear viable, each carries distinct limitations that must be evaluated carefully. Vendor selection decisions directly influence timelines, sample analysis, regulatory exposure, and the sponsor’s ability to maintain control across the supply chain.

Evaluating Courier Options: CROs, CMOs, and Specialized Vendors

In some scenarios, a CRO may coordinate dummy dose retrieval using a local, in-country courier. This approach can be effective when shipments remain domestic and/or logistic and regulatory requirements are limited. However, local couriers often lack the capability to manage cross-border shipments, temperature-sensitive materials, or complex customs requirements. In many countries, the absence of a qualified Importer of Record makes this option unsuitable for international retrieval. Sponsors may also consider CMO-affiliated couriers or logistics providers. While some CMOs offer support for dummy dose retrieval, this capability is not consistent across regions and often relies on third-party vendors. These vendors may not be authorized to act as Importer of Record or may lack experience handling sample returns associated with investigational product oversight. In practice, many sponsors find that fully vetted courier vendors with global clinical trial experience offer the most reliable solution, as they are typically more familiar with export and import requirements, customs authority interactions, and time-sensitive sample deliveries.

Documentation, Temperature Control, and Packaging Requirements

Regardless of the vendor selected, accurate documentation is crucial to successful dummy dose sample collection. Vendors must demonstrate the ability to prepare and review Proforma Invoices that clearly and correctly describe the nature of the shipment. Errors or omissions at this stage are among the most common causes of customs delays and shipment rejection. Temperature requirements and sample characteristics must also be clearly defined. Depending on the product and study design, dummy dose samples may require controlled conditions. Investigational sites may not be able to provide packaging and shipment materials, so vendors should be able to provide appropriate packaging solutions that maintain sample integrity throughout transit and comply with applicable regulations.

Importer of Record and Customs Clearance Considerations

Regardless of the vendor selected, accurate documentation is crucial to successful dummy dose sample collection. Vendors must demonstrate the ability to prepare and review Proforma Invoices that clearly and correctly describe the nature of the shipment. Errors or omissions at this stage are among the most common causes of customs delays and shipment rejection. Temperature requirements and sample characteristics must also be clearly defined. Depending on the product and study design, dummy dose samples may require controlled conditions. Investigational sites may not be able to provide packaging and shipment materials, so vendors should be able to provide appropriate packaging solutions that maintain sample integrity throughout transit and comply with applicable regulations.

Integrating Dummy Dose Collection into Clinical Supply Risk Management

Dummy dose sample collection sits at the intersection of clinical supply oversight, regulatory compliance, and site performance monitoring. It requires the same level of planning, vendor qualification, and operational discipline as investigational product distribution. As clinical trials continue to expand globally and regulatory expectations increase, dummy dose collection should be incorporated into broader clinical supply risk management strategies rather than treated as an adhoc activity. Sponsors that approach dummy dose retrieval with rigor are better positioned to confirm dosing compliance, support their sites effectively, and maintain control across global supply chains.

Dummy dose retrieval should reinforce oversight, not introduce new risk. CSC supports sponsors with clinical supply planning, vendor qualification, and global logistics strategies that help standardize dummy dose processes, reduce regulatory exposure, and protect patient safety. If you’re building or refining your dummy dose collection approach, connect with CSC to ensure your process is compliant, inspection-ready, and designed to scale.