Biopharmaceutical and medical device companies are increasingly focused on making it as easy as possible for patients and caregivers to participate in clinical trials. Sponsors are designing more patient-centric studies to address the challenges of recruiting and retaining study participants. New technologies, including wearables, telehealth visits, online patient diaries, eConsent, video dosing confirmation, and patient apps are making decentralized trials more feasible and appealing. Sterling IRB’s expertise helps you pivot quick and navigate the appropriate regulatory requirements for decentralized trials.
Below are guidances in designing an IRB-ready protocol for either a fully or partially decentralized trial:
The protocol should include:
- Requirements for trial-specific procedures, including details for activities that must occur at the investigative sites, those that can be performed by a local or mobile health care provider (HCP), and those that can use mobile technology solutions.
- Information regarding study-specific training and education for investigators and study staff to ensure protocol compliance.
- Site management instructions for handling source documents at decentralized sites and methods to ensure that only the study participant or other appropriate site-related personnel enter data when a device is used for data collection.
Other IRB considerations include:
- Process for screening and qualifying home-care staff to ensure that risks to study participants are minimized.
- Availability of medical equipment to home-care staff during their conduct of protocol defined procedures.
- Local context considerations relevant to each state where the research will occur.
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