SYNOPSIS/PROTOCOL
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1. Clinical Investigation Plan
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- For clinical investigation, protocol and synopsis shall be prepared that describe the rationale, objectives, design, methodology, monitoring, statistical considerations, organization and conduct of a clinical investigation.
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2. The Protocol shall consist of the following content :
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- Identification of the clinical investigation plan
- Sponsor
- Investigation information (Investigator, Site, etc)
- Synopsis
- Medical Device information
- Risks and benefits of the medical device and clinical investigation
- Objectives and hypotheses of clinical investigation
- Design (Subjects, Procedure, Monitoring Plan)
- Statistical considerations
- Data management
- Deviation from clinical investigation plan
- Statements of compliance
- Informed consent process
- Adverse events / effects
- Population
- Suspension of premature termination of the clinical investigation
- Bibliography
- Etc
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3. Synopsis for clinical investigation shall consist of the following :
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- Inclusion/exclusion criteria
- Number of subjects
- Duration of the clinical investigation
- Follow-up
- Objective(s)
- Endpoint(s)
- Etc
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