Description
Why it is useful
ISO 14155 GCP emphasises the importance of selecting competent investigators and suitable research sites to conduct clinical trials in a reliable and compliant manner. The Site and investigator qualification questionnaire serves as a comprehensive tool to evaluate the capabilities, qualifications, and facilities of potential investigators and research sites prior to their involvement in clinical trials.
The questionnaire encompasses a range of essential aspects, including the investigator’s experience, expertise, medical qualifications, training, infrastructure, resources, and track record in conducting clinical research. It also assesses the site’s infrastructure, facilities, and adherence to ethical and regulatory requirements.
How to use it
1. Gather necessary information to make informed decisions regarding the selection of investigators and research sites.
2. Use the template as an inspiration for creating your own questionnaire.
3. Use the template as a benchmark to check your own existing questionnaire.
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.
