When visits, nursing, drug delivery or data collection move out of the clinic, participants need to understand who will come to their home, what gets shipped, where their data goes and what to do in an emergency. These are the sections to add.
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How this study works at home
Video visits and telemedicine
Home nurse visits
Study medicine delivered to your home
Devices, apps and your data
Emergencies and your own doctor
Costs and reimbursement
Key points
Template sections
| Section | What to explain | Example wording to adapt |
|---|---|---|
| How the study works at home | Which activities happen remotely and which at the site | Some study visits will happen by video call from your home. You will still visit the clinic for your first and last visits. |
| Video visits | Platform, privacy, recording, what happens if the connection fails | Video calls are not recorded. If the call drops, the study team will phone you. |
| Home nurse visits | Who visits, what they do, scheduling, identification | A nurse from [company] will visit to take blood samples. They will show identification. |
| Medicine delivered to your home | Courier, storage, returns, what to do if a delivery is damaged | Your study medicine will be delivered by courier. Keep it in the fridge and return unused packs. |
| Devices, apps and your data | What is collected, how often, which companies receive data | The watch records your heart rate and steps. This data is sent to [vendor] and then to the study team. |
| Emergencies and your own doctor | Remote monitoring is not emergency care; who to contact | The study team does not watch your data in real time. In an emergency, call your local emergency number. |
| Costs and reimbursement | Data charges, travel for remaining site visits, reimbursement | We will reimburse mobile data used for the study app. |
Example wording is illustrative; adapt it to your study and have it reviewed by your ethics committee.
Data flows
In a site-based trial, participant data mostly stays between the site and the sponsor. In a decentralized trial it passes through more hands: a telemedicine platform, a home nursing company, a courier, a device manufacturer's cloud, the eCOA or EDC provider. Participants have a right to understand that, and ethics committees increasingly ask for a clear description or diagram of data flows.
Describe each recipient in plain language: what it receives, why, and whether it can identify the participant. Under GDPR these organisations are usually processors acting for the sponsor, and the consent form or information sheet should say so. The decentralized clinical trial guide covers the wider design questions.
Participant at home
Diary, device, video visits
Home nurse and courier
Name, address, samples, delivery
Device vendor cloud
Sensor data under a study ID
Study data system
Pseudonymised for the sponsor
Remote eConsent
Capture's eConsent lets participants read and sign on their own device. The participant acknowledges the legal statement and signs on screen, confirmed with a one-time code by email, and the investigator countersigns with password re-authentication. The document is fully executed only after countersignature, and each signature is linked to the exact document content.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Try the remote consent flow as participant and investigator in the free sandbox.
Before submission
Video visits, home nursing, direct-to-patient supply, devices.
Home nursing and courier providers, with what they see.
What goes where, in plain language.
Who to call and when to go to a local hospital.
Remote consent and shipping rules in each country.
Reviewed with patients or a readability check.
All standard consent elements, plus explanations of each remote element: video visits, home nursing, direct-to-patient shipment, devices and apps, data recipients, emergencies and costs.
Yes, where regulations and the ethics committee allow, with identity verification and an investigator countersignature.
They should understand what data each recipient receives and why. Ethics committees often ask for a data flow description.
No. The consent form should say clearly that data is not watched in real time and who to contact in an emergency.
Yes. Adapt the sections to your study and have them reviewed by your ethics committee.
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