Module 15 2022

20/05/2022

Remember the Lifecycle of a Clinical Study?

Study Regulatory Approval

Study Design

Study Conduct

Study Close-out

Report

» Determine overall strategy » Develop study design and create protocol

» REC approval » Regulatory agency agreement » Hospital contract » Monitoring plan » DMC » Train investigator and staff » Develop data management process

» Enroll and follow subjects » Collect all data » Address any complications » Monitor data and device use to ensure integrity of data and safety of subjects » Audit

» Compile and analyze data

» Resolve any

pending issues » Retrieve devices » Compile Clinical Investigation report » Dissemination of results » Archive study documents for 10 15years

» Generate reports » Submit report in

regulatory application » Prepare for Inspection

» Statistical » Investigator

qualification and selection

» Manufacture clinical product

» Follow subjects through conclusion of study

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 8

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Clinical Investigation: Elements of the CIP / ISO

Subjects Number, period, Inclusion, Exclusion Criteria, Milestones Procedure Description of investigation related procedures Monitoring Plan Outline of monitoring plan Statistical Consideration Design, Sample Size, level of significance, power, drop out rate, pass/failure criteria, interim analysis, final analysis Data Management Data review, electronic data system, data retention, QA

Protocol/CIP deviations Not allowed except for emergency, recording of PDs, notification requirements, CAPA, PI disqualification criteria Device accountability Description of procedure Compliance statement Adherence to Decl.o. Helsinki, ISO, local regulations, approval, EC/Regulatory Auth. Requirements, Insurance Informed Consent Description of process, emergency treatment AE, ADE, Device Deficiency Definitions, reporting, DMC

Administrative Info Title, Version, Sponsor, PIs Overall Synopsis Summary of investigation Device Description Manufacturing, Identification, training, Intended purpose Justification of design Evaluation report: Pre-clinical, clinical data Risk Benefit Clinical benefits, adverse device effects, residual risk Objective and hypothesis Objective, hypothesis, claims, residual risks to be assessed Design Type of investigation, type of measurements, endpoints, device & comparator (incl. justification

Vulnerable Subjects Description, ICF process, EC

Suspension/ Premature termination Criteria for termination, Breaking the blind, Subject follow-up Publication Policy Statement result publication Bibliography List of references relevant for investigation

CIP Amendment Procedure for CIP amendments

Module 15 Lecture 8

The Organisation for Professionals in Regulatory Affairs

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