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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

What is the GCP HelpDesk?
The GCP HelpDesk is a support service provided to respond to queries raised by Investigators/Physicians on Good Clinical Practice in Clinical Research. It provides a central point of contact on global GCP issues and ensures that consistent replies are provided to questions. The HelpDesk also allows the users to give their feedback, which will be continuously reviewed in order to improve its services and helps in regularly updating the list of Frequently Asked Questions (FAQs) published on its website.

How to access the HelpDesk?
To access the HelpDesk, first click on “FAQs” which appears on every web page (left of the page):

  • Click on “Frequently Asked Questions” to reach the collection of answers to questions regularly raised by users. Click on relevant topic name and a list of questions will appear.
  • Find the question and read the answer.
  • If the list of questions and answers do not provide you with a reply to your specific query, you can contact the HelpDesk via the Ask a GCP Expert by posting a question where you can get personalized answers by email.

How to send a question?

  • To send a question, click on GCP HelpDesk
  • You will then be asked to identify yourself:Name, Email, Phone Number
  • Type-in your question and make sure all the fields are filled in. Questions in English are only accepted. Avoid browsing other web pages at this stage as you may lose what you have typed.
  • Click on “Send” your question.
  • An automatic message will appear and confirm that your question has been sent to the HelpDesk.
  • At this stage you can to return to the HelpDesk menu.
  • You will receive a “Confirmation Email” within approximately 10 minutes, giving you the question’s reference number.
  • If you do not receive the “Confirmation E-mail”, then please check your “Junk” folder and the “Spam” settings in case the email was delivered to these folders instead of to your “Inbox”. It may also be that there was a typographical error in the e-mail address you entered when posting a question to HelpDesk.

Receiving a response

  • Once the GCP HelpDesk has responded to your question, you will receive an e-mail.
  • You can ask for further clarifications on your original question by completing a new question form.


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
There are no events at this time