Clinical investigation plans for medical devices

A clinical investigation plan is the protocol a medical device study is approved and conducted on, written against ISO 14155. The parts divide by what a writer of the plan has to settle: how a device investigation differs from the drug trial a writer may know better, the standards and regulations the plan answers to, how the plan is prepared and drafted, and what its sections say, from the identification of the plan and the device through the design of the study to its provisions for conduct, ethics and safety. The drug-trial protocol and the estimand framework that shapes it are left to clinical study protocols, the ICH E6 and SPIRIT content lists to where a protocol's content requirements come from, the structured protocol to the structured protocol and ICH M11, the participant-facing document to patient information and informed consent for device investigations, and the report of the investigation to clinical study reports for medical devices.

• How a device investigation differs from a drug trial — how hard a device protocol is to write, where the investigation documents differ in guideline, templates, terminology and safety reporting, how the investigation itself differs, from the missing phase I in healthy volunteers to blinding and the writer's influence, and the investigation types set against the phases of drug development
• Standards and regulations behind a device investigation plan — the layers of requirement a plan answers to, the Declaration of Helsinki, what ISO 14155 covers and how far it binds a study, the changes and principles of its 2020 edition, clinical investigations under the Medical Device Regulation, and disease-specific guidelines
• Preparing and drafting a clinical investigation plan — what the plan is and who signs it, the clinical evaluation and risk documents it is built on, the inputs and published studies to gather before drafting, templates and the standard's content without its order, who contributes, the synopsis drafted and agreed first, reviews and the writing schedule, and consistency within the plan and with a drug protocol
• Identifying the plan and describing the investigational device — the plan's identification and the people responsible, the device and its intended purpose against its indication, device accountability, the introduction, the justification for the design, and the risks and benefits
• Setting out the design of a device study — objectives, hypotheses and claims, an unregulated study-type vocabulary, designs adapted from medicinal products, few unambiguous endpoints, eligibility a site can apply and the withdrawal and replacement of subjects, the point of enrolment and analysis populations, duration and sample size, procedures and the comparator, and the statistical section with its cap on subjects per centre
• Conduct, ethics and safety provisions in the plan — data handling, monitoring and source verification, deviations, the compliance and ethics statements with post-study access, consent and vulnerable populations, device deficiency and the other safety terms, safety reporting and the oversight committees, stopping the investigation and following up subjects, and the publication policy