Home Nursing, Local Providers and Investigator Oversight

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

When a home nurse, a local clinic or a mobile unit does part of the work, the investigator is not standing next to them. Annex 2 does not say the investigator stops being responsible. It says oversight should be appropriate and proportionate, and it explains what that means when the work is spread out.

Oversight is proportionate, not absent

Annex 2 section 2.4 says the investigator should keep appropriate and proportionate oversight of trial activities, to protect participants and the reliability of the data. The level depends on the nature of the activity, how important the data are and the risk to participants. It can range from direct supervision, to less intensive oversight in person or by video, phone or email, to review of essential records, including source records.

So there is no single right level. A home blood draw for a pharmacokinetic sample at an exact time needs closer oversight than a routine weight. What matters is that the investigator has thought about it and can show how they oversee each kind of task.

Sponsor-arranged providers

Sponsors often contract home nursing companies. Section 3.8 says that when a sponsor arranges activities that are under the investigator's responsibility, such as home nursing, the sponsor should make sure the provider is suitable. In those circumstances, the investigator keeps the ability to decide whether the proposed provider is appropriate, and is responsible for overseeing their activities.

For site staff, this means a request to "countersign the vendor acknowledgment by Friday" deserves questions. What are the nurses' qualifications? How are they trained on this protocol? How do samples, results and problems reach the site? A signature given with nothing in front of the investigator is not oversight.

Healthcare professionals working within usual care

Some trials rely on healthcare professionals who are not on the study team, such as a participant's own primary care doctor. Section 2.4.1 separates two cases.

Usual care tasks that need no protocol knowledge. If a task is part of usual clinical practice and does not require knowing the protocol, the investigator's brochure or trial manuals, the professional does not have to be trained on the protocol. Instead, appropriate arrangements should be in place to make the relevant information and records available to the investigator. The Annex lists what those arrangements cover: how data are shared, how records are kept (for example as certified copies), how privacy is maintained and how data integrity is assured.

Tasks that need protocol knowledge. If the task is part of usual practice but does require knowledge of the protocol or other trial documents, it should be done by delegated healthcare professionals who have been appropriately trained.

In both cases, the investigator's oversight should be proportionate to how critical the data are, and this applies whether the sponsor or the investigator arranged the professionals.

A simple test helps: could a competent clinician do this task correctly without ever reading the protocol? A routine blood pressure in clinic, yes. A foot examination scored on a trial-specific scale, no.

Safety information from the field

Section 2.5 says the investigator should review safety information across all sources. Information generated by home nursing, remote visits and DHTs should reach the investigator in a way that lets them make decisions on the participant's care. Section 3.2.5 asks the protocol to describe how safety information from these sources is collected, how potential safety concerns are identified and made available to the investigator in a timely manner, and what the investigator should do. Section 3.9.1 asks the sponsor to have processes that make it accessible in time.

A data flow that syncs within 72 hours may be fine for routine readings. It is not a safety route. If a home nurse finds something worrying, they follow the protocol's safety steps and contact the investigator directly, then record what was done.

Privacy when providers come to the home

Section 3.7 notes that service providers may need personal information, for example when a home nurse is sent to a participant. Sponsors and providers should make sure the participant has given appropriate consent, that the information is protected from accidental disclosure, and that access is limited to those authorized.

In practice

• For each off-site task, know who does it, whether they need protocol training and delegation, and how their records reach the investigator.
• Ask for a provider's qualifications, protocol training plan and reporting lines before the investigator accepts them.
• Agree a direct safety route from home visits to the investigator, separate from routine data syncs.
• Check that participants were told which providers will receive their contact details.

Key takeaways

• Investigator oversight must be appropriate and proportionate, and it can take several forms (Annex 2, section 2.4).
• For sponsor-arranged providers, the investigator still decides whether they are appropriate and oversees their work (section 3.8).
• Usual care tasks need records arrangements; tasks that need protocol knowledge need delegation and training (section 2.4.1).
• Safety information from home visits must reach the investigator in time to act (sections 2.5, 3.2.5 and 3.9.1).