Clinical research and biomedicine - The influence of the Clinical Trial Directive/Regulation
12 important questions on Clinical research and biomedicine - The influence of the Clinical Trial Directive/Regulation
What is the number of the clinical trial regulation?
The approach to clinical trials are different in all the MS, however there are 3 things that has to be organized, which?
- Principles of clinical confidentiality and disclosure of patient information
- Inclusion of vulnerable groups
- Different structures for application of clinical trials
What are the 3 policy aims of the directive/regulation?
- Protecting individual research subjects: focus on good clinical practice
- Harmonisation of the reporting procedures for safety, monitoring and surveillance of procedures
- Ensuring that the approval procedures for trials are speeded up to facilitate scientific progress
- Higher grades + faster learning
- Never study anything twice
- 100% sure, 100% understanding
For my 1st exam I got a C. Then, I started looking for ways to learn better and I came across Study Smart. Since then I have scored a A+, A, A- and another A. I highly recommend it to everyone who wants to hear it. I am so happy with it!!
I was struggling to finish all my first-year subjects for 3 years. Then I discovered Study Smart, which helped me to finish all of them within 3 months.
Because of StudySmart, things are going well in many ways. Before, I always had study stress and no time for anything. Now I feel calm and confident (because of the program). I used to score a B, now I usually score an A or A+.
Hey Chris, I really want to thank you very much for developing the platform, I usually got around C for my exams, now I scored an A+, an A and a A- !!
Since using Study Smart, my average has increased significantly. I even completed a statistics course with a A+ while I'm bad at statistics. I took on extra courses this year, because of Study Smart. Thanks so much!
Ever since I started studying with StudySmart I passed all my exams !!! No more re-sits!! At first, I was happy with a pass and now I only get good grades. Many thanks!
I aced all the courses I studied with Study Smart. For law, I first scored a D, and now an A! I’m 100% sure that I’ll pass all the courses I study with Study Smart.
I always thought I studied well. My grades were fine. I could never have imagined that applying these study skills would have such a huge and direct impact on my grades, my speed and the pleasure I have in learning.
For the first time, I finally feel totally confident about the way I learn. I have the perfect overview and make great progress in terms of speed and the grades I get. Thanks, Chris!
I immediately started to enjoy learning again, and my grades soared. All of a sudden, everything went better. I highly recommend Study Smart to all students..
Being able to create my materials online made the process of studying so much smoother and quicker. I no longer have to spend a huge amount of my time on creating my summaries.
At first, my notes were a mess. Now I use Study Smart to take my notes in a perfectly structured way. It helps me to save a lot of time and do other things I enjoy.
Students that study with Study Smart get better grades. The system applies all the learning methods in such a way that both well-performing students and students who struggle perform much better.
Hi Chris, I would like to thank you very much. Last year I scored C on a course, and this year I got an A+ thanks to your method! Thank you very much!
The largest effect is that my child is more enthusiastic about school! Every parent wants their children to be happy at school, Study Smart made it happen.
In high school, I failed several exams, and that has really changed now. I actually needed this tool very much back then. Since I started studying with StudySmart, I haven't had any D's. My average score is now an A and those are results I would have never had in the past
With my old method, I passed only 3 out of 8 courses. Since I started taking my notes digitally in Study Smart, I have passed all my courses on the first try. For me, StudySmart takes away the stress of wondering if I will pass or not.
Thanks to StudySmart, I passed all my exams, and with better grades than before! On top of that, I have mastered a very good study method now, which I am confident will help me earn my degree.
What is the goal of the Clinical Trial Regulation? How is it achieved (7)?
- Single submission dossier submitting via a single EU portal
- Simplified rules for low intervention clinical trials
- Extension of the tacit agreement principle to whole authorization process
- Commission can conduct controls
- Consistent rules for conducting clinical trials
- New indemnity rules reducing the burden for non commercial sponsors
- Integrity/transparancy of research data
On which legal basis does the EU have competences in the field of clinical research? For the directive and for the regulation?
Regulation: art. 114 TFEU & 168.4 TFEU
What is the scope of application of the directive?
- only about clinical trials: research conducted on humans and that are necessary to test the medicinal product
- experimental treatment is excluded
- does not apply to:
- psychological research
- research into medical devices
- research into tissue, organs or blood
- embryo research
- = only the MS have the competence to deal with these
Which article sets out the basic guidelines for the ethics committee to conducer when assessing trials?
What has been added to the role of the committee since the regulation?
- it's an independent body
- the review may encompass aspect addressed in part 1 and 2
How does art. 29 of the regulation protect the clinical trial subject?
- written, dated and signed
- duly informed
- informed consent shall be documenten
- adequate time to consider his participation
Information duty
- enable to understand
- be kept comprehensive
- provided in a prior interview
- info about damage compensation system
- info on EU trial number and about availability of trial
- summary of results will be available in EU database
Which specific articles protect minors and mentally incapacitated adults
Art. 31-33 regulation
What provisions are related to surveillance of trials?
- info concerning trials in MS is to be entered into a central EU database
Art. 40-46 Regulation
- electronic database
- reporting to the sponsor
- reporting to the agency
- annual reporting
- assessment by member states
What 3 aspects are still to be regulated by the member states after the adoption of the regulation
- "Who can be a legal representative"
- Authorization and oversight of clinical trials: remains the responsibility of MS
- Ethically controversial research bv cloning
- MS may maintain additional measures regarding
- persons performing mandatory military service
- persons deprived of liberty
- persons wh cannot take part in clinical trials
The question on the page originate from the summary of the following study material:
- A unique study and practice tool
- Never study anything twice again
- Get the grades you hope for
- 100% sure, 100% understanding
