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Investigator site file checklist template

Investigator Site File Checklist Template (ISO 14155, Medical Device)

49,00 €

This Investigator site file (ISF) checklist is a structured tool used in medical device clinical investigations following the ISO 14155 standard.

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Description

Why it is useful

This checklist ensures that all essential documents and records related to the clinical site and study activities are complete, organised, and compliant.
It covers items like ethics approvals, investigator qualifications, informed consent forms, and other critical documentation, facilitating a systematic and standardised approach to trial management and regulatory compliance.

How to use it

1. Use it to support the review of your investigator site file.
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 want to learn more about using the template or clinical investigations in general, it is covered in our online course: Introduction to 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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