Lab testing in decentralized clinical trials: a planning guide for sponsors
Moving sample collection out of the clinic is one of the most practical ways to make a study easier to join. A participant who can collect a sample at home, or at a lab near work, doesn't have to take half a day off for every visit. But once collection leaves the site, the lab plan has to do more of the work.
This guide walks through the lab questions sponsors and CROs should settle before the first kit ships. It draws on FDA's guidance on decentralized trials, the updated ICH good clinical practice guideline and CMS's position on research testing under CLIA.
What FDA's guidance says about labs in decentralized trials
In September 2024, FDA finalized Conducting Clinical Trials With Decentralized Elements. One point is easy to miss: FDA's requirements are the same whether or not a trial includes decentralized elements. Remote collection changes the logistics, not the standard.
The guidance makes a few lab-specific points worth building into the protocol:
Local clinical labs close to participants are generally appropriate for routine tests that are well standardized.
Designated labs should handle tests that are specialized or specific to the trial.
Specimens may be collected by remote trial staff, local providers, local labs or by participants using home collection kits, then sent to a designated lab for processing.
For drug trials under an IND, all clinical lab facilities must be listed on Form FDA 1572. If a network of labs is used, the network headquarters may be listed instead of each satellite lab.
In practice, many studies end up hybrid: safety labs at local facilities, and study endpoints at one designated lab so every result comes from the same methods.
Where ICH E6(R3) fits
FDA published E6(R3) Good Clinical Practice as final guidance in September 2025. Its emphasis on quality by design and risk-proportionate oversight applies directly to lab logistics. The questions are simple: which lab steps could affect participant safety or the reliability of results, and how will you control them?
ICH then adopted E6(R3) Annex 2 in June 2026. It covers trials with decentralized elements, pragmatic elements and real-world data. Check how and when your regulators are putting Annex 2 into effect. Even before then, it's a useful checklist for remote collection.
Does your study lab need to be CLIA-certified?
It depends on what happens to the results. CMS explains in its research testing and CLIA fact sheet that CLIA applies when patient-specific results are reported and could be used for diagnosis, prevention, treatment or assessing a person's health.
Likely exempt: research labs that report only group-level results, such as "10 of 30 participants were positive." This is the research exemption in 42 CFR 493.3(b)(2).
Presumed subject to CLIA: testing where an individual participant's result is reported and could inform their care. Safety labs and any results returned to participants or their clinicians usually fall here.
Not a substitute: IRB approval doesn't settle the question. CMS notes that IRBs have no authority to decide CLIA applicability.
If your protocol returns individual results, or might later, plan on a CLIA-certified lab from the start. Switching labs mid-study is far harder than choosing the right one up front.
Pre-analytical variables: the biggest risk in home collection
Most lab errors don't happen on the instrument. A widely cited review in Clinical Chemistry and Laboratory Medicine found that pre-analytical factors accounted for 46–68.2% of total laboratory errors. Home collection adds more steps before the sample reaches the lab, so this is where the planning effort should go.
Collection
Confirm that each analyte is validated for the sample type you plan to use, such as capillary blood, dried blood spot, saliva, urine or swab.
Write participant instructions for a first-time collector, with pictures. Then test them with people who haven't seen the protocol.
Decide how timing will be recorded, such as fasting status, time of day or time since dose, if the endpoint depends on it.
Transport
Map the stability window for each analyte against realistic transit times, including weekends and carrier delays.
Decide whether samples need temperature control or can ship at ambient temperature.
Where specimens ship as Category B biological substances, follow 49 CFR 173.199. That means triple packaging and the Category B diamond mark on the outer package.
Receipt and rejection
Agree on rejection criteria before enrollment, such as insufficient volume, hemolysis, missing labels or samples outside the stability window.
Decide what happens next when a sample is rejected. Will a replacement kit ship automatically, and who tells the participant?
Track rejection rates by site, region and kit lot so problems show up early.
Kit design is part of the protocol
A kit isn't just a box. Every component affects data quality: the collection device, labels, requisition, instructions, return mailer and packaging. Standardized kits help make sure every participant collects the same way, which matters most when samples feed a study endpoint.
Points to settle with your lab and kit partner:
Who builds and stores kits, and how kit lots and expiration dates are tracked.
How each kit is tied to a participant ID without exposing identifying information where the protocol doesn't call for it.
Whether kits carry sponsor branding, study branding or neutral packaging.
How kit inventory is replenished across sites and home shipments.
Some sponsors pull kit building, storage and shipping under one partner, using a white-label kit and 3PL service. That keeps the chain of custody in one place.
Results delivery and data integrity
Decide early how results will move, and who sees them:
Format: structured data, such as an API feed or file transfer, avoids manual re-keying and the errors it brings.
Routing: results may go to the investigator, the EDC system, a safety monitor or, where the protocol allows, the participant.
Audit trail: you should be able to trace every result back to a kit, a collection time and a received-sample record.
Inspection readiness: FDA's guidance expects investigators to keep a record of the clinical labs participants use during the trial.
A short planning checklist
Before the first participant is enrolled, the study team should be able to answer yes to each of these:
Is every analyte validated for the sample type and shipping conditions we plan to use?
Is every lab used for patient-specific results CLIA-certified, and licensed in the states that require it?
Are all clinical labs listed on Form FDA 1572 (for IND studies) or identified in the investigational plan (for device studies)?
Are rejection criteria and recollection steps written down and agreed with the lab?
Can we trace any result back to a kit, a participant and a collection time?
Where a single lab helps
Using one designated lab for study-specific tests reduces variability between methods and keeps the data in one format. It also gives the study team one point of contact when a sample goes wrong. IHDLab, a CLIA-certified laboratory (05D2040304) licensed in California, New York and Maryland, supports clinical research teams with standardized home collection kits and in-house testing.
Whichever lab you choose, settle the lab questions in this guide before the protocol is final.
This article is for general information only and isn't legal, regulatory or medical advice. Confirm requirements for your study with your regulatory and quality teams.
