The purpose of the following questionnaire is to evaluate the differences between the old EU clinical trial directive (2001/20/EC) and the new EU clinical trial regulation (536/2014) and the impact of the changes going forward. As part of my MSc dissertation at Griffith College, Dublin, Ireland, I am asking people who work in the area of clinical research to answer the following questions to assess their knowledge about the guidelines and their opinions on the new regulations. The survey should only take a few minutes to complete. All the information collected and the identities of those participating will be kept strictly confidential.

Question Title

* 1. Your Gender

Question Title

* 2. Your Age Group

Question Title

* 3. Your Job Title or area of work in Clinical Industry

Question Title

* 4. Your Location in the world

Question Title

* 5. Did you know there is a new clinical trial regulation 536/2014 being implemented to replace the old directive 2001/20/EC?

Question Title

* 6. Are you familiar with the old directive 2001/20/EC?

Question Title

* 7. Are you familiar with the new regulation 536/2014?

Question Title

* 8. Have you received training on the new clinical trial regulations?

Question Title

* 9. Do you think the new regulation will save time?

Question Title

* 10. Do you think the new regulation will be cost effective?

Question Title

* 11. Do you think the use of a single online portal is a good idea?

Question Title

* 12. Do you think removing national laws from Member States is a good decision?

Question Title

* 13. Do you think that a three-year transition time from the old directive to the new regulation is sufficient?

Question Title

* 14. Do you think the new regulation will give the EU an advantage over the rest of the world?

Question Title

* 15. What do you think will be the impact of the new EU Regulation on Clinical Trials?

Question Title

* 16. What do you think will be the impact of the new EU Regulation on CROs and Pharmaceutical companies?

Question Title

* 17. Do you think the new Regulation will be better than the previous directive? If Yes, in what way?

Question Title

* 18. Do you think implementation of the new regulation will be easy or not?

Question Title

* 19. What do you think the future holds for the clinical trial industry in terms of regulation?

T