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CLINICAL INVESTIGATION PLAN (according to DIN EN ISO 14155:201201)ASSESSMENT OF THE CAPABILITY OF PULMOVISTA 500 TO CONTINUOUSLY MONITOR CHANGES OF VENTILATION OVER TIME. PulmoVista 500 Multi center,
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How to fill out clinical investigation plan
How to fill out clinical investigation plan
01
Begin by reviewing the regulatory requirements and guidelines related to clinical investigation plans in your country or region.
02
Identify the objectives and scope of the clinical investigation plan, including the device or drug being investigated, the target population, and the intended use.
03
Develop a protocol outlining the study design, methodology, and data collection procedures. This should include details on the study population, sample size, inclusion and exclusion criteria, study endpoints, and statistical analysis plan.
04
Create a comprehensive study timeline, including key milestones and deadlines for each phase of the investigation.
05
Determine the resources and budget required for the clinical investigation, including personnel, equipment, facilities, and funding.
06
Conduct a risk assessment to identify potential risks and develop strategies to mitigate them.
07
Obtain ethical and regulatory approvals from relevant authorities and ethics committees.
08
Recruit and train study investigators and site personnel who will be responsible for conducting the investigation and collecting data.
09
Implement the clinical investigation according to the protocol and monitor the progress of the study regularly.
10
Collect and analyze the data obtained from the investigation, ensuring compliance with data protection and privacy regulations.
11
Prepare a final report summarizing the findings of the clinical investigation, including any safety concerns or adverse events.
12
Review and revise the clinical investigation plan as necessary based on the results and conclusions drawn from the investigation.
Who needs clinical investigation plan?
01
Clinical investigation plans are needed by medical device manufacturers, pharmaceutical companies, and researchers conducting clinical trials.
02
Regulatory authorities and ethics committees also require clinical investigation plans to ensure that studies are conducted in a safe and ethical manner.
03
Healthcare professionals may also benefit from clinical investigation plans to understand the rationale and design of clinical studies.
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What is clinical investigation plan?
A clinical investigation plan is a detailed document outlining the objectives, methodology, and timeline for conducting a clinical study.
Who is required to file clinical investigation plan?
The sponsor or applicant of a clinical study is required to file the clinical investigation plan.
How to fill out clinical investigation plan?
The clinical investigation plan should be filled out with detailed information on study objectives, methodology, participant criteria, data collection procedures, and statistical analysis.
What is the purpose of clinical investigation plan?
The purpose of a clinical investigation plan is to provide a roadmap for conducting a clinical study in a systematic and ethical manner.
What information must be reported on clinical investigation plan?
The clinical investigation plan must include details on study objectives, methodology, participant eligibility criteria, data collection procedures, and statistical analysis plan.
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