Patient samples are critical to the success of modern clinical trials. Managing the collection and transport of study samples at specific timepoints can be complex, particularly in multicenter, biomarker-guided trials. Having a well-written clinical trial lab manual that provides trial sites with detailed instructions on all aspects of sample management, from ordering kits to shipping samples to the processing laboratory, helps ensure a consistent way of working that leads to high quality data.
Designing a clinical trial lab manual
The key to developing an effective lab manual is ensuring that it aligns with the protocol and that no detail is overlooked. When designing the manual, it is important to perform the following tasks:
- Outline which kit type(s) will be needed for each scheduled study visit
- Identify what type of sample will be collected with which type of collection tube
- Determine the requirements for shipping kits, including who will act as the importer of record, what the local regulations are, kit quantities for each site, and where the kits will be inventoried
- Define timelines and requirements for inbound logistics to the processing laboratory, including turnaround and transit times for critical samples, what notifications will be needed, and whether a premium courier is needed to meet requirements, such as temperature tracking or GPS monitoring
At this stage, it is also essential to clarify the shipment condition and frequency, destination, and preferred courier for each sample type. In addition, plan to provide sites with shipping materials for safe sample transport.
In situations where supply chains may be compromised (for example, global production and shipments recovering from COVID-19 impacts), it may be a good idea to build flexibility into collection tube selection and to identify alternate tubes if stock is unavailable, such as during supply chain disruptions
Decisions made during the initial development of a clinical trial lab manual—along with the supporting rationale—should be recorded in a design document that will guide drafting of the manual itself. Ideas such as color-coding tubes for different assays may aid site staff in collecting samples correctly.
Drafting a clinical study lab manual
The most effective clinical trial lab manuals are user-friendly and contain all the information site staff need to collect, process, store, and ship samples in accordance with the study protocol. Clinical trial lab manuals typically contain the following key components:
|A table of contents allows users to easily find and navigate to the information they need.
|Central lab contacts that include the following:
|The general guidelines for specimen collection kits, including instructions on storing the kits, checking the expiration date relative to the schedule of assessments, not mixing components between kits, and using auxiliary kits as substitutes for when specific visit kits are not available. Good practice is to include guidelines on how and when to order kits, including estimated lead times, and to provide an example of a correctly filled out Kit Request Form for each kit type.
|Sample requisition forms detail the information that must be provided with each sample and the labeling requirements for sample tubes. Providing examples of correctly filled out sample requisition forms and tube labels can help ensure compliance.
|The laboratory test collection schedule is typically extrapolated from the schedule of assessments and outlines the kit and collection type for each study visit. In some studies, the schedule will outline which color tubes are used for which downstream assays. Generally, the schedule will list the number of kits supplied, each kit’s contents, and even the residual kit components that remain after sample collection.
|Sample collection order and instructions on collection and preparation provides details on how to use each of the collection tubes in each kit. Sample collection order may impact downstream analysis and be critical for assay quality. For instance, blood drawn for measuring matrix metalloproteinases (MMPs) should be the first tube as MMP may be affected by platelet activation. Some split kits may have two parts—one containing tubes at ambient temperature and another containing tubes that require special handling, such as being kept frozen until use. In such cases, collection and preparation instructions should be included in both the manual and the kit itself.
|Organizing packaging and shipping instructions by shipper type helps maintain specimen viability, prevent damage during shipping, and ensure proper routing and handling of the shipper when received by the processing laboratory. Oftentimes, the site is supplied with ambient, refrigerated, and frozen shippers as needed, but site staff need to be aware of which shipper to use for each type of collection tube, when to ship them, what courier to use, and where to send them. Providing step-by-step instructions and images for all procedures makes it easier for site staff to comply with the requirements. If additional components, such as dry ice, are required but not supplied to the site, it is critical to ensure the site can procure such components. If a premium courier is used, there may be an additional level of complexity as these couriers may have their own instructions or restrictions regarding pickup and transit times.
|Contact information for shipment notifications to processing labs that includes details on the information that must be sent to the receiving lab.
|A revision history that shows all the changes that have been made to the clinical study lab manual since its release and the rationale supporting those changes.
Advantages of an effective clinical study lab manual
A well-written, effective clinical trial lab manual serves the needs of both clinical and laboratory operations staff by creating a clear, consistent, and seamless workflow for sample collection, processing, storage, and shipment at each study visit. Getting the study lab manual right the first time not only eases site burden and enables risk mitigation, but also ensures the value of study samples is captured in quality data that drives science forward.