Study Drug Shipped to the Participant

Part of ICH E6(R3) Annex 2 for Site Staff: Home Visits, Local Providers and Study Drug at Home.

About 5 minutes. Free, in your language, no account needed.

Expert review pending. CRLN wrote this lesson against the ICH E6(R3) Annex 2 text adopted on 3 June 2026. It has not yet been reviewed by a subject matter expert. Always follow your protocol, your sponsor and your regulator.

Why this matters

Investigational product (IP) that travels to a participant's home leaves the controlled path of the site pharmacy. It can be delivered to the wrong person, stored at the wrong temperature or arrive in a box that tells the neighbors what disease the participant has. Annex 2 lists what to think through before and during home supply.

The range of approaches

Annex 2 section 2.3 says IP management, meaning supply, storage, dispensing, administration, return, accountability documentation, destruction or other disposition, can be handled in various ways. IP may be supplied to the participant or to an appropriate designee, such as a caregiver, home nurse or local pharmacist, for use at the participant's location. These arrangements must follow applicable regulatory requirements, which vary by country.

When the site ships

Section 2.3.1 says the investigator or institution may send IP to the participant, following the sponsor's documented instructions where applicable. Five things should be considered:

When the sponsor ships

Section 2.3.2 says that where regulations allow, the sponsor may ship IP to the participant directly. In that case:

Section 3.6.2 adds a rule site staff should know by heart: the sponsor should make sure a shipment to a participant starts only after the investigator has authorized it. If you see a home shipment queued that nobody at the site authorized, especially when continuing treatment depends on results the investigator has not reviewed, ask for it to be held and tell the investigator.

Using what the pharmacy already does

Section 2.3.3 says existing institutional documentation and processes may be enough, depending on local requirements. For example, a pharmacy's standard accountability and storage records may be appropriate. You do not always need a separate trial-only system.

What the investigator oversees

Section 2.3.4 says the investigator should keep appropriate oversight of IP management and make sure documentation is kept. The level of oversight depends on the trial design, the product, the route and complexity of administration, what is known about its safety and its marketing status. Oversight covers at least:

Point (b) matters at home. If a local pharmacist or a family member changes the dose, even for a sensible reason, the decision has gone around the investigator. Report it to the investigator, who decides under the protocol, and record exactly what was taken.

What the sponsor plans

Sections 3.6.1 and 3.6.3 ask sponsors to assess home supply during protocol development, considering stability and storage needs, preparation, route, the population, the safety profile, any need for observation after a dose, blinding and emergency plans. Sponsors may use systems such as interactive response technology or DHTs, and processes such as home nurse visits, to confirm delivery and administration. Section 3.7 reminds sponsors and providers that couriers and nurses receive personal information and that it must be protected.

In practice

Key takeaways