What do sites and study teams really want to know about using remote, in-home visits as part of their clinical trial protocols?
Home trial services have been utilized by innovative sites for years as a way to access difficult-to-reach subjects, increase recruitment, improve patient satisfaction and retention, and essentially to do more even when pinched for time and resources otherwise. More recently, the pandemic threw the critical need for more accessible study visits into the spotlight. Sites that haven’t used home trial services to date, however, have questions. And rightly so. The most common questions we get from sites about home trial services revolve around one or more of the following:
- IRB approval
- Liability insurance
- Oversight
- Study contribution
- GDPR
- Training
Here are the answers to those common questions and some additional resources study teams have found helpful.
1 Do home trial providers require IRB approval from their own IRB/IEC?
Firma’s home healthcare nurses serve as an extension of the PI and Investigator Site. As such, they are covered under the same IRB approval as the Investigator Site.
#2 Do home trial providers have liability insurance?
They should. Firma holds shared indemnification with either the CRO or Sponsor. During the term of the study and two years after, Firma secures and maintains adequate insurance to cover obligations as indicated in Firma’s scope of work with the CRO or Sponsor.
#3 Who has oversight of the home healthcare providers?
The PI/Site always has full oversight of the study, subject, and home healthcare nurses. Firma’s oversees the study training (knowledge transfer), provision of supplies, issue resolution (non-health-related, like delayed couriers), and notification of home visit requests.
Additionally, Firma gives PIs all home healthcare providers’ credentials and can coordinate telephone interviews with the nurses, so the PI has all the information required to appropriately delegate home visit procedures.
All visit activities and observations are recorded by the home healthcare nurses and shared with the PI/Site to aid them in their responsibilities.
#4 Will home healthcare providers conducting in-home trial visits make a direct and significant contribution to the trial data?
Not in most cases. Home healthcare nurses provide intermittent care, documenting clinical data. They do not make any treatment decisions for the subject. In Firma’s case, we do not maintain any original lab or study data once those are provided to the site for EDC entry and inclusion in the study file.
#5 Does all data collected within the framework of an in-home visit and transferred to the United States comply with GDPR?
Your in-home trial partner should treat all individually identifiable health information as confidential in accordance with all applicable laws and local regulations, including without limitation to HIPAA and GDPR.
#6 Who trains home healthcare providers?
Training is one of the most critical elements of successful in-home visits and should be a core feature of the services your home trial partner provides. Firma conducts extensive training for all of our home healthcare nurses based on materials we pre-approve with the CRO or Sponsor, including protocol-specific and general home trial visit activities.
What does training usually entail? Jennifer Goff, RN, one of Firma’s home visit nurses, explains all the ins and outs.