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Clinical investigation plan checklist (CIP)

Clinical Investigation Plan Checklist Template (ISO 14155, Medical Device)

49,00 €

This Clinical investigation plan (CIP) checklist is intended for medical device clinical investigations in adherence to ISO 14155, and is a structured tool to ensure compliance with regulatory requirements.

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Description

Why it is useful

The CIP checklist aids research teams in preparing comprehensive clinical investigation plans by systematically covering all essential elements required for a successful study. This checklist encompasses critical aspects like study objectives, design, ethical considerations, regulatory compliance, risk assessment, and data management. Utilising this checklist ensures that the clinical investigation plan aligns with ISO 14155 standards, promoting the quality and integrity of the research while adhering to regulatory guidelines.

How to use it

  1. Use it to support the review of your informed consent form.
  2. Use the template as an inspiration for creating your own checklist.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customised to work with the current project.

Support

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need clinical investigation training and a course certificate?

Should you want to learn more about using the template or clinical investigations in general, it is covered in our online course: Clinical Investigation for Medical Devices and ISO 14155.

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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.

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