Cannabis clinical trial software that records product, use and safety in one study

Cannabis and cannabinoid research covers a wide range: purified cannabidiol (CBD) products, THC-containing extracts, whole-plant products, and observational studies of people who use products they obtained themselves. The regulatory position differs by product and country. In the United States, federal scheduling of marijuana has been in flux during 2026, with reports of a partial move of some FDA-approved and state-licensed products to a less restricted schedule while others remain in Schedule I, so researchers should check current DEA and FDA sources for registration and sourcing rules. Hemp-derived CBD, approved cannabinoid medicines and unregulated retail products are treated differently again, and other countries have their own licensing systems. This page makes no claim about legal status; your sponsor, regulatory advisor and ethics board carry that responsibility.

That uncertainty has a data consequence: the study record must show exactly what product was used. Historically, many trials struggled because the available product did not resemble what people use in daily life, which limited generalisability. Where a study can now source products more flexibly, product variability becomes the central data problem. Record the product type, the cannabinoid content stated on the certificate of analysis, the batch or lot, the expiry, the route (oral, inhaled, topical) and the dispensing date, as structured fields rather than a name typed into a notes box.

Capture is a data capture system. It does not verify product quality, license a researcher, or ensure compliance with controlled-substance law. It supports the records around the product: dispensing and returns recorded in the study, and generic accountability reporting described below.

Safety monitoring depends on the product. Protocols for CBD products commonly monitor liver enzymes at set visits, because raised transaminases have been a documented concern in some studies at higher exposures; the schedule and thresholds are protocol-defined and should come from your own safety documents. Build the lab form with units and reference ranges, add edit checks that raise a query for values beyond a protocol limit, and link a flagged value to an adverse event record. The lab results template is a repeating table suited to this purpose, and AI-assisted drafting can turn a lab sheet into a draft table for your review.

THC-containing products add questions about psychiatric events, impaired cognition and driving, and cannabis use disorder screening in some populations. Record such events with typed fields rather than free text, and use the adverse event form with an event-of-special-interest flag if the protocol defines one. Depression and anxiety scales have structure pages such as PHQ-9 and GAD-7; structure and scoring only, with licences remaining your responsibility.

Self-reported use is imperfect but central. Daily diaries on the phone, with reminders, give a time-stamped record. See digital patient diary software and BYOD ePRO with no app download. Observational studies of patients who obtain products outside the study are a registry-style design; see EDC for registry studies. For pain indications, see EDC for chronic pain clinical trials.