Description
Why it is useful
You need to maintain records from your clinical investigation activities and be able to demonstrate traceability all the way from initial planning to the final reporting of the clinical investigation. This is easily done using the Annex E listing all the essential documents.
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.
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.