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Informed Consent Checklist Template (ISO 14155, Medical Device)

49,00 €

This downloadable Informed consent checklist template is a vital tool designed to ensure that all necessary and pertinent information is included within the informed consent document in accordance with ISO 14155.

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Description

Why it is useful

This checklist serves as a systematic guide to verify that essential elements such as the study’s purpose, risks, benefits, confidentiality measures, and the voluntary nature of participation are adequately addressed.
By using this checklist, researchers can confirm that their informed consent forms are comprehensive and compliant with ISO 14155 standards, safeguarding the rights and well-being of study participants.

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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