Depending on the nature of your clinical study, you may have to seek approval from and submit documentation to one or more accredited medical ethical research committees and national regulatory authorities. Like many investigators, you may find preparing this documentation to be time-consuming and bureaucratic.
At the TCC, we can carry out the whole process of application for approval from medical ethical research committees and national regulatory authorities. We can also support you in carrying out this process yourself. Our staff can reduce the amount of work for you by assembling the documentation, submitting the documentation or responding to comments by external bodies.
To help ensure that you get approval for your study quickly and efficiently, we review the guidelines for submissions to ethics committees and national competent authorities. We have also developed clear checklists for this process. We have supported submissions to competent authorities and ethics committees for international and multi-center studies and in a range of European countries. These include:
- The Netherlands.
- The United Kingdom.
- The Republic of Ireland.